cyrilzakka/clinical-trials huggingface dataset:
Influence of a Liquid Oat Bran Product on Blood Glucose in Patients With Poorly Controlled Type 2 Diabetes

This study evaluates the effects of an ad libitum addition of a high fiber product to the regular diet of type 2 diabetes patients on body weight and blood sugar control. In the first 6 weeks half of the participants will receive the high fiber test product and half a reference product without fiber. After the first 6 weeks both groups will be switched to the high fiber product.

It has previously been shown that an increase in the consumption of fiber improves glucose control in type 2 diabetes. In addition, previous pilot studies have shown that a diet solely based on oat flakes can improve insulin sensitivity and glucose control in poorly controlled type 2 diabetes. Recent clinical data indicates, that early hyperglycemia can be normalized by a diet high in fiber. In this controlled pilot study, a food containing liquid oat bran high in fiber will be studied in type 2 diabetes patients with inadequate glucose control that are treated with oral medication or with additional once-daily insulin only against a reference product. 30 patients will be treated with the oat bran product or reference product over a period of 6 weeks in a double blinded approach, hereafter all participants will be switched to the oat bran product. The primary endpoint will be fasting glucose after 6 weeks. Secondary endpoints will be long-term glucose control as measured by HbA1c, self-documented glucose as well as the body weight and body mass index.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes with inadequate glucose control and a HbA1c \>7,5 and \< 9%
* Treatment with all oral antidiabetic medication or injectable GLP-1 analogues
* BMI 28,0-39,9 kg/m²
* Age 30-70 years

Exclusion Criteria:

* insulin treatment
* Psychiatric Disease
* Acute Infections
* Alcohol or drug abuse
* Acute diverticulitis
* Malignant tumors or hematologic disorders
* Heart failure NYHA III-IV
* Acute coronary syndrome
* Chronic kidney disease \> Stage 3 (KDOQI)
* Pregnancy or Lactation
* Previous bariatric interventions
Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Growth failure due to growth hormone insufficiency (GHD)
* Turner syndrome: established diagnosis according to sex chromosome analysis, or
* Growth retardation in children with chronic renal disorders

Exclusion Criteria:

* Pregnancy
* Breast feeding women
* Suspected or know allergy to trial product
* Participating in any other trial involving other investigational products within the last 3 months
* Previous participation in the trial
* Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
Comparison Effects Of Different Exercise Approaches On Type 2 DM Women

Type 2 Diabetes Mellitus (T2DM) is one of the most common metabolic diseases with a complex, multifactorial aetiology, and is a chronic disease with various clinical and biochemical manifestations. It has been known for a long time that T2DM treatments are medication, diet, and exercise. Exercise can improve blood glucose control, increase insulin sensitivity, respiratory capacity, well-being and cognitive functions, regulate lipid profile, blood pressure, reduce cardiovascular disease risk, abdominal obesity, weight. Although there are many studies in the literature on the effects of exercise in T2DM, there is no consensus on which exercise protocol is more effective. In the studies, the obstacles in front of the diabetic patients' adaptation to exercise; laziness, lack of motivation and energy, embarrassment from family and social environment, lack of support, timelessness, financial problems, lack of space to exercise, fear of hypoglycaemia, pain, stiffness, fatigue, shortness of breath, presence of additional diseases, fear of injury. Blue Prescription (BP) is a model developed to facilitate the continuous participation in physical activity. In traditional home programs, patients are told what to do. The BP approach, on the other hand, involves providing the person with options for physical activity, removing the barriers to activity instead of the classical home exercise program or physical activity counselling, and being in communication with the way the person wants during this process. This approach has been developed to facilitate participation in physical activity and to ensure the sustainability of physical activity in individuals with chronic diseases. Philosophy of the approach aims to increase the activity level gradually, improve the quality of life and continuous participation in the activity with motivational interview, continuous support, communication and activity diary, instead of recommending physical activity with classical methods due to the different needs, desires and tastes of people. Studies using the BP in the literature have focused on Multiple Sclerosis and stroke, and no publications on other chronic diseases have been found. The aim of this study is to examine the effects of BP, video-based home exercise and supervised group exercises on HbA1c, physical activity level, functional capacity and other metabolic control variables in primary care women with T2DM.


Eligibility Criteria:
Inclusion Criteria:

1. Between 25-65 years of age
2. Having Type 2 DM for at least 5 years
3. HbA1c value\> 6.5% / Fasting blood glucose\> 126 mg / dl
4. Ability to walk independently
5. Volunteering to participate in research

Exclusion Criteria:

1. Type 1 DM
2. Using insulin
3. Orthopedic and neurological diseases that prevent exercise
4. Having cardiovascular, pulmonary and systemic diseases in which exercise is contraindicated.
Efficacy of STABL Virtual Rehabilitation

The purpose of the proposed study is to evaluate the efficacy of STABL rehabilitation vs in-person rehabilitation following meniscectomy or synovectomy. STABL is a digital health platform that uses computer-vision technology to facilitate at-home post-op recovery for patients while enabling remote monitoring by their surgeon.

Patients undergoing minor knee procedures (defined as meniscectomy and synovectomy) will be randomized to virtual rehabilitation using the STABL platform or standard physical therapy over the course of 6 weeks to determine any possible difference in clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Underwent meniscectomy or synovectomy surgery
* Age 18-65
* Ability to comply with a standardized postoperative protocol
* Willing and able to provide consent

Exclusion Criteria:

* Previous knee surgery
* Patients at any increased risk of falls or at increased risk from harm due to falling, including issues with vertigo, osteoporosis, or a history of past falls
* Patient otherwise deemed at increased risk from this investigational rehabilitation program by their referring surgeon or physical therapist
* Patients who are pregnant
Swedish External Support Study

Randomized study to evaluate the effect of adding external support to PTFE-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage.


Eligibility Criteria:
Inclusion Criteria:

Critical limb ischemia Need for bypass surgery

Exclusion Criteria:

Can participate in follow-up Has suitable saphenous vein
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries

This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits

Background: Pulpectomy is the reference treatment for vital primary molars with irreversible pulpitis.Over the past decades, dental caries has unfailingly been the most common chronic infectious disease of childhood and adults. If remained untreated, it can potentially compromise dental pulp tissue. When the dental pulp of primary teeth is irreversibly inflamed, the first treatment choice is pulpectomy, owing to the well-recognized importance of primary tooth retention for child oral/general health. Although a pulpless tooth can remain functional in the oral cavity, modern pediatric endodontics encourages regenerative approaches in primary teeth.The introduction of calcium silicate-based (CS-B) biomaterials such as mineral trioxide aggregate (MTA), along with further understanding of pulp biology and inflammatory processes, has revolutionized treatment modalities for management of irreversible pulpitis in mature permanent teeth. A growing body of evidence has revealed successful implementation of minimally invasive endodontics, that is, vital pulp therapies (VPTs) for management of permanent teeth with irreversible pulpitis even when associated with apical periodontitis. Due to the traditional notion of poorer healing capacity of primary dental pulp, such a paradigm shift has not been seen in pediatric dentistry.Recent research revealed similar vascular/immune responses of primary and permanent dental pulps to caries; therefore, indicating that their healing potential might be this in mind, a reevaluation of traditional approaches for treatment of inflamed primary pulp seems justified.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 4 to 6 years , in good general health
2. The parents provided written informed consent.
3. Clinical characteristics, defined as spontaneous pain and the presence of a deep carious lesion with pulp exposure and bleeding that did not halt within five minutes following removal of the coronal pulp tissue.
4. Restorable teeth.

Exclusion Criteria:

1. Physical or mental disability.
2. Unable to attend follow-up visits.
3. Previously accessed teeth.
4. Swelling, tenderness to percussion or palpation, or pathological mobility.
5. Pre-operative radiographic pathology such as resorption (internal or external), per-radicular or furcation radiolucency.
Effect of Pulsed Electromagnetic Stimulation on DOMS

The aim of our study is to investigate the effect of Pulsed Electro Magnetic Field application on delayed muscle soreness in healthy Quadriceps femoris muscle.

Participants will complete 100 consecutive fall jumps from a 0.60 m high platform to generate Delayed muscle soreness. After landing, participants will be encouraged to jump vertically immediately with maximum force. Five sets of 20 jumps will be performed with 10-second intervals between each jump, with a 2-minute rest between sets.Immediately after the implementation of the exercise protocol that will cause delayed muscle soreness, the participants will be randomly divided into 2 groups. Pulsed Electromagnetic Field or sham Pulsed Electromagnetic Field application will be applied to the non-dominant extremities of the participants.

The participants will be evaluated before (0), 24, 48 and 72 hours after the delayed muscle pain protocol.

Pain intensity of the participants will be evaluated with Visual Pain Scale (VAS), muscle fatigue will be evaluated with Modified Borg Scale, muscle performance will be evaluated with one-leg jump test, and muscle tenderness will be evaluated with an algometer.

In addition, serum creatine kinase and myoglabin values will be tested by laboratory analysis.

Eligibility Criteria:
Inclusion Criteria:

* not having any systemic disease
* not having neuromuscular deficit
* not having knee pathology
* To be defined as inactive (less than 30 minutes of moderate physical activity five times a week) according to the minimum activity guidelines published by the American College of Sports Medicine

Exclusion Criteria:

* Being actively involved in any sport
* participating in a regular exercise program
Pilot Study of Irreversible Electroporation (IRE) to Treat Metastatic Liver Cancer & Cholangiocarcinoma

Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.

Single-arm pilot clinical trial. Patients will be subjected to irreversible electroporation (IRE) as the sole treatment of nodules not considered treatable by resection or thermal ablation.

This pilot study was designed to study the feasibility and safety of treatment as an alternative therapeutic IRE in the treatment of neoplastic nodules in the liver, with particular reference to metastatic liver cancer and cholangiocarcinoma, where the current therapeutic arsenal is inadequate or counter-indicated.

To perform the IRE procedure the IRE NanoKnife™ System (AngioDynamics) will be used.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years,
* male or female,
* diagnosis of secondary liver cancer or cholangiocarcinoma based on positive biopsy or noninvasive criteria,
* presence of at least one lesion untreatable by surgical resection or ablation for microwave or radio frequency,
* the target nodule must have a diameter of ≤ 5 cm
* ECOG score(Eastern Cooperative Oncology Group) 0,
* ASA score (American Society of Anesthesiologists) ≤ 3,
* prothrombin time ratio \>50%
* platelet count \>50x10\^9/l,
* patient's ability to discontinue anticoagulant and antiplatelet therapy for seven days before and seven days after surgery with NanoKnife™,
* ability to understand and willingness to sign the written informed consent form (ICF),
* life expectancy of at least 3 months.

Exclusion Criteria:

* presence of more than 5 liver lesions,
* previous treatment of the target nodule,
* patient received systemic chemotherapy within 30 days of treatment with the IRE NanoKnife™,
* heart failure, coronary artery disease or arrhythmia in progress, active implantable devices (eg pacemaker),
* pregnant women or women of childbearing potential not using an acceptable method of contraception,
* patient undergoing treatment with an investigational drug within 30 days of treatment with the IRE NanoKnife™,
* in the opinion of the researcher, anyone who can not follow the calendar of visits and assessments of the Protocol.
Applying Num Vapocoolant Spray to Cervix Before Paracervical Block to Decrease Pain During Gynecology Procedures

The purpose of this study is to assess if Num vapocoolant spray decreases pain associated with paracervical block in gynecology procedures.

After patients seen in our clinic have decided to proceed with a gynecology procedure that requires a paracervical block, the doctor will evaluate if the patient meets eligibility criteria for this study. If the patient does meet eligibility criteria, the doctor will inform the patient about the study and the potential risks. All patients will be given written informed consent. If the patient decides to participate in the study, they will be randomized (patient blinded) to receive either Num vapocoolant spray or placebo (normal saline spray), which the patient will receive during their gynecologic procedure just before the paracervical block. The purpose of this study is to see if the Num vapocoolant spray decreases patients pain with the paracervical block.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or older

Undergoing a procedure requiring paracervical block

English-speaking

Able and willing to sign the informed consent form and agree to terms of the study

Exclusion Criteria:

* Required or requested narcotics, anxiolytics, IV sedation, or general anesthesia for the procedure

Declines or has a contraindication/allergy to ibuprofen

Previously received vapocoolant spray in a medical setting

Contraindications or allergies to lidocaine for paracervical block or vapocoolant spray components (1,1,3,3-pentafluoropropaine or 1,1,1,2-tetrafluroethane)
University Hospital Advanced Age Pregnant Cohort

The University Hospital Advanced Age Pregnant (UNIHOPE) Cohort is the major part of the National Key Research and Development Program on Reproductive Health \& Major Birth Defects Control and Prevention Project, which is funded by the Ministry of Science and Technology of China. The Project is led by Prof. Zhao Yangyu, from the Department of Gynecology \& Obstetrics, Peking University Third Hospital, and the UNIHOPE cohort is led by Prof. Jian-meng Liu, the Co-PI of the Project.

The UNIHOPE Cohort is set up to provide comprehensive evidence for the prevention and treatment of gestational complications in pregnant women with advanced maternal age, and therefore, to meet the growing clinical challenges of increasing pregnant women with advanced age in the two-child era. The UNIHOPE Cohort is planning to recruit 22,000 pregnant women aged ≥35 years from 9 large obstetrical center of major University-affiliated Hospitals across China, between July 2016 and December 2020. All women will be enrolled prior to 14 wks of gestation, followed up at 24-28 wks, 32-34 wks of gestation, delivery, and 42 days postpartum. Data including demographics, medical history, reproductive history, prenatal health care, gestational complications, and pregnancy and birth outcomes will be collected via electronic data capture system. Venous blood of the pregnant women will be collected at enrollment and each follow-up visit during pregnancy, and placental tissue, cord blood and hair of the newborn will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* Female aged ≥ 35 years
* Less than 14 gestational weeks
* Planning to receive prenatal healthcare and delivery service at the study hospital

Exclusion Criteria:

* Inability to provide informed consent
* Women with mental disorders
Impact and Performance of Institutionalizing Immediate Post-partum IUD Services

Studying the impact and performance of institutionalizing immediate post-partum IUD services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Tanzania, and Nepal.

The International Federation of Gynaecology and Obstetrics (FIGO) has designed and is planning to implement, through its nationally-affiliated Associations of Gynaecologists and Obstetricians, an intervention program on post-partum IUD (PPIUD) services. As part of this Program, FIGO is responsible for information material, training providers, improving facilities, quality of service, and monitoring the program. Independent of the implementation, this study will measure the impact and performance of this intervention in three (Sri Lanka, Nepal and Tanzania) of the six countries participating in the FIGO project entitled: "Institutionalization of immediate post-partum IUD (PPIUD) services as a routine part of antenatal counselling and delivery room services in Sri Lanka, Kenya, India, Tanzania, Nepal and Bangladesh." The FIGO intervention will take place over a nine-month period in Tanzania (nine months in the first group of three hospitals and three months in the second group of three hospitals), and over a fifteen-month period in Nepal and Sri Lanka (fifteen months in the first group of three hospitals and nine months in the second group of three hospitals). Investigators will study both the impact of the intervention on the uptake and subsequent continued use of PPIUD and the extent to which the intervention leads to the institutionalization of postpartum IUD services in the hospitals during and after the FIGO intervention and to what extent the service diffuses to other hospitals or providers. The institutionalization and diffusion of the intervention will be measured by interviewing and following up trained providers, review of hospital records and baseline, during intervention and post-intervention facility surveys.

Eligibility Criteria:
Inclusion Criteria:

* Delivered in intervention hospital during 12-month enrollment period (Tanzania)/18-month enrollment period (Nepal and Sri Lanka)

Exclusion Criteria:

* Does not live in the country where delivered
* Tanzania only: Under age 18
The Effect of Interscalene Block on Intracranial Pressure

The study aims to show the effects of interscalene brachial plexus (ISBP) block on intracranial pressure by measuring optic nerve sheath diameter (ONSD) and internal vein collapsibility index (IJV-CI).

40 is the targeted number of patients who are going to have humerus fracture or opened rotator-cuff surgery. Single shot-ISBP block with 25 ml local anesthetic will be performed as anesthetic approach for surgery to all participants. Intraoperative ONSD and IJV-CI measurements will be performed before the ISBP block, 20 minutes and 60 minutes after the block. Hypothesis; external drug-volume effect on internal jugular vein causes decreasing maximum diameter of internal jugular vein (Dmax), venous return from cranium to heart decreases, intracranial pressure can increase.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had elective humeral fracture and open rotator-cuff surgery,
* Patients aged 18-85 years,
* Patients have ASA I-II anesthesia risk according to the American Society of Anesthesiologists (ASA) risk classification,
* Patients that gave consent for participation in the study will be included.

Exclusion Criteria:

* Patients who do not give consent to the study,
* Patients with infection and open wounds in the area of skin puncture and eyelids,
* Patients have any history of intracranial pathology,
* Patients have nerve blockade contraindications such as coagulation disorder and antithrombotic-anticoagulant use,
* Patients have a history of allergy to one of the study drugs,
* Patients have a body mass index over 35 kg/m2,
* Patients with contralateral pneumothorax,
* Patients with severe respiratory distress,
* Patients with uncontrolled hypertension,
* Patients with acute or chronic eye disease,
* Patients with previous eye surgery,
* Patients using a beta-blocker known to increase intraocular pressure,
* Patients using calcium channel blockers, statins and nitrates,
* Patients in need of intraoperative sedation,
* Patients who develope any complications (hoarseness, horner's syndrome, respiratory distress, local anesthetic toxicity) due to ISBP block will be excluded from the study.
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Repeated Doses of PF-04958242 in Healthy Volunteers

This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a number of ascending doses administered once daily for 14 days in healthy volunteers.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-child bearing potential Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* History of seizures or of a condition with risk of seizures
* Pregnant or nursing females, and females of child bearing potential
Ketamine Trial for the Treatment of Depression

This study is a Randomized Controlled Trial, investigating the safety and efficacy of administration of ketamine as a potential treatment for depression.


Eligibility Criteria:
Individuals will be eligible for enrolment on the basis of:

* major depressive disorder for at least three months duration
* an inadequate response to at least 2 adequate antidepressants
* MADRS ≥ 20

Patients will be excluded on the basis of:

* History of psychosis
* History of bipolar disorder
* Any unstable medical or neurologic condition
* Any Axis I disorder other than MDD judged to be primary presenting problem
* Planned major changes to psychotropic medication
* Significant risk of suicide
* Planned or probable use of ECT
* Age under 16 years, or 16-17 years without parental consent
* Substance abuse or dependence in previous 6 months
* Any history of abuse of ketamine or phencyclidine
* Contraindication to the use of ketamine
* Planned use of ketamine
* Women of childbearing potential not taking reliable contraception
* Likely non-compliance with trial treatment
* Other condition judged by the treating clinician as likely to impact on the ability of the participant to complete the trial