cyrilzakka/clinical-trials huggingface dataset:
Home-based Program "T&E" for Fall Prevention and QoL in Elderly: a Randomised Control Pilot-study

The aim of the pilot-study is to evaluate the feasability of a future RCT, regarding recruitement of eligible participants, adhesion rate, datarecording and cost. In this feasibility pilot study, 18 patients with at least 65 years will be allocated randomly to one of two interventions. The control group gets a well-known home-based exercise program (OTAGO) aiming to prevent falls where the exercises are prescribed by a physical therapists. The exercises will be presented on a booklet and on printed cards. The Intervention group consists of an exercise program, the "T\&E" program, where the elderly persons can choose the exercises depending on their abilities. The exercises in the "T\&E" program will be presented in a printed manual and shown on videos on an electronic tablet. Both intervention groups receive 6 hours of instruction and control/supervision sessions by physical therapists. In addition, the participants will exercise alone.

The interventions will be performed over 24 weeks.

In this pilot study, the hypothesis is that the adhesion rate is at least 65%. Other feasibility criteria will be costs, data recording issues and the qualitative evaluation of the booklet and the tablet.

Falls will be assessed with a falls calendar. The amount of physical activity of the participants is assessed with an accelerometers (actigraph) and quality of life will be assessed with OPQOL-35 at baseline, week 16 and week 24.


Eligibility Criteria:
Inclusion Criteria:

* Living at home
* Ability to perform standing position independently with/without walking aids (rollator crutch)
* Reported fall(s) during the last 12 months and/or fear of falling (Short FES-I ≥8)
* Understand french / german

Exclusion Criteria:

* Actually in treatment with a physical therapist
* Participate at an other home-based programm exercises
* MMS Score ≥ 25.
A Phase 1 Dose Escalation Study of Intravenous VX-993 in Healthy Adults

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of intravenously administered VX-993 at different doses in healthy participants.

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m\^2), inclusive
* A total body weight of more than (\>) 50 kg
* Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug

Key Exclusion Criteria:

* History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug.
* Any condition possibly affecting drug distribution, metabolism, or excretion

Other protocol defined Inclusion/Exclusion criteria may apply.
EUS Biliary Drainage vs. ERCP

Endoscopic ultrasound guided biliary drainage (EUS-BD) is an evolving field that has grown in popularity in the management of malignant biliary obstruction. Although Endoscopic retrograde cholangio-pancreatography (ERCP) with stent insertion has been the mainstay therapy throughout several decades, the transpapillary approach through tumor tissue is associated with significant risk for adverse events such as post-ERCP pancreatitis and stent dysfunction from tumor tissue overgrowth and ingrowth. EUS-BD, through the creation of a choledochoduodenostomy with a stent, has the potential advantage of avoiding the papilla and its associated complications while potentially improving stent patency with lower risks for tumor tissue ingrowth and/or overgrowth.


Eligibility Criteria:
Inclusion Criteria:

* Radiological diagnosis (with or without pathological diagnosis) of borderline resectable, locally advanced, or unresectable malignant distal biliary obstruction at least 2 cm distal to the hilum. Resectability based on tumor staging on axial imaging and surgeon evaluation.
* Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (18.9 umol/L)
* Dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or US
* Confirmation of bile duct accessibility and size of at least 1.2 cm on endoscopic ultrasound
* Karnofsky index \> 30%
* ASA score \<IV
* Provision of informed consent

Exclusion Criteria:

* Hilar obstruction (biliary obstruction \< 2 cm from the hilum)
* Uncorrectable coagulopathy and/or thrombocytopenia
* Age \< 18
* Liver metastasis involving \> 30% of the liver volume
* Liver cirrhosis with portal hypertension or ascites
* Prior biliary sphincterotomy or stent placement
* Surgically altered anatomy
* Common bile duct measuring less than 1.2 cm will be excluded
* Patient with clinical and radiological evidence of gastric outlet obstruction
Obstructive Sleep Apnea Syndrome in Glaucoma

The aim of the study is to determine if plasma matrix-metalloproteinase activity can predict glaucoma in patients with OSAS and if the level of plasma matrix-metalloproteinase activity will decrease after one month of nCPAP-treatment.

Glaucoma is a leading cause of blindness world-wide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The key feature of glaucoma is damage to the optic nerve head, which is not necessarily related to an increased intraocular pressure. The prevalence of glaucoma among the patients with sleep apnoea was 7,2%: normal-tension glaucoma 2,9%, primary open-angle glaucoma 4,3%. The prevalence of obstructive sleep apnoea syndrome (OSAS) is around 4-10% for men and 2-4% for women. Matrix metalloproteinases (MMPs) substrates include essentially all extracellular matrix components as well as a wide array of molecules involved in intracellular adhesion, cell-matrix interaction, and cell signalling. However, MMPs effects are not restricted to extracellular matrix degradation. The prevalence of increased MMP in patients with OSAS and its predicting value for an additional glaucoma are not known. Further, we do not know if treatment of OSAS with nasal continuous positive air pressure(nCPAP) can decrease the MMP activity. With this study, we want to determine the prevalence of MMP activity and the prevalence of glaucoma in patients with OSAS. Further, we want to investigate if a nCPAP treatment period of four weeks decreases the MMP activity.

Eligibility Criteria:
Inclusion Criteria:

* OSAS planned begin of a nCPAP treatment

Exclusion Criteria:

* Current malignancy
* Oral steroids
Blood Pressure in the Emergency Department

This is a cohort study based on a large sample (\> 600 000) of emergency department (ED) visits from two university hospital EDs. Information on incident disease after discharge from the ED will be collected through linkage to Swedish national in-patient register and cause of death register. The importance of blood pressure measured at the ED for incident atherosclerotic cardiovascular disease during long term follow up will be studied by Cox-regression analysis


Eligibility Criteria:
Inclusion Criteria:

* Attending the Emergency departments (ED) at Karolinska University hospital in Solna or Huddinge during the specified time period
* Record of blood pressure measurement from the ED-visit

Exclusion Criteria:
Effects of Acupressure and Foot Massage on Pain During Heel Lancing in Neonates

Aim: The study was aimed to identifying the effects of foot massage and acupressure on pain during heel lancing in neonates.

Methods: A single-blinded randomized controlled trial was performed in a university hospital in Turkey between April-December 2018. Neonates were randomized into three groups as acupressure, massage and control groups. Data were obtained by using Information form, Neonatal Infant Pain Scale (NIPS), pulse oximeter device and chronometer. Acupressure was applied to the neonates in the acupressure group and massage was given to the neonates in the massage group for 2 minutes before heel lancing procedure. Pain levels of the neonates in the groups were evaluated during and 1 minute after heel lancing procedure. Furthermore, the oxygen saturation and heart rate values of the neonates in the groups were measured by pulse oximeter device before, during and after heel lancing procedure. Duration of crying and heel lancing procedure were recorded by chronometer.

Massage is a systematic and scientific procedure applied by using hands or special tools. As for acupressure, it is a method applied by stimulating the acupuncture points using hands and fingers by applying pressure on the meridians in body.Both methods are reliable, economic and easy to learn and apply. Review of the related literature indicates studies on the effectiveness of acupressure and foot massage on reducing pain in neonates.

Eligibility Criteria:
Inclusion Criteria:

* having 2500-4000 gr body weight and being term neonates,
* having APGAR score of over 7 five minutes after birth,
* having no health problems detected in the newborn examination after birth,
* having received no painful interventions apart from Hepatitis B and Kvit after birth,
* being with the mother and being fed orally,
* having had breast milk within 30 minutes before heel lancing
* having a clean diaper.
Comforting Conversation During Colonoscopy: A Trial on Patient Satisfaction

Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management.

Does comforting conversation during colonoscopy improve on patient satisfaction, compliance and pain management. A randomized controlled trial on comforting conversation or standard communication during colonoscopy. Using a mixed methods model, a qualitative study will be conducted to clarify what patients deem as important or effective conversation during colonoscopy. A randomized controlled trial will hereafter be conducted, where the results from the initial study will be utilized in the conversation during colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-85
* Colonoscopy
* Written informed content

Exclusion Criteria:

* ASA Class 4 or higher
* BMI 40 or higher
* Analgesics taken prior to procedure
* Pregnancy or breast feeding
* Allergy to Fentanyl/Midazolam
* Daily consumption of opioids
* Unable to complete questionnaire
Safety and Efficacy of LX4211 With Metformin in Type 2 Diabetes Patients With Inadequate Glycemic Control on Metformin

This study is intended to assess the effect on HbA1c of different dose regimens of LX4211 in combination with metformin in subjects with Type 2 Diabetes Mellitus who have inadequate glycemic control on metformin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects between the ages of 18 to 75 years, inclusive
* Confirmed diagnosis of Type 2 diabetes mellitus
* Meet required laboratory values at screening, including fasting plasma glucose less than 270 mg/dL
* Stable dose of metformin monotherapy greater than 1500 mg/day for at least 8 weeks
* Willing and able to provide written informed consent
* Willing and able to maintain consistent dietary, physical activity, and sleeping patterns throughout the study

Exclusion Criteria:

* History of Type 1 diabetes mellitus, diabetic ketoacidosis, hyperosmolar nonketotic syndrome, or diabetes resulting from pancreatic disorder or secondary diabetes
* History of renal disease or clinically significant abnormal kidney function tests
* Presence of active hepatic disease or clinically significant abnormal liver function tests
* Subjects with a history of heart attack, severe/unstable angina, or coronary revascularization procedure within 6 months prior to study Day 1
* History of clinically significant cardiac arrhythmias within one year of study Day 1
* Subjects with congestive heart failure
* Subjects with uncontrolled Stage III hypertension
* Triglycerides \>1000 mg/dL at Screening
* Known history of HIV or hepatitis C
* History of illicit drug or alcohol abuse with one year of study Day 1
* Have had 2 or more emergency room visits, doctor visits, or hospitalizations due to hypoglycemia within 6 months of study Day 1
* Use of any other investigational drug within 30 days of study Day 1
* Prior exposure to LX4211
* Use of any medication or herbal supplement for the purpose of weight loss
* Chronic use of any antidiabetic therapy other than metformin in the 3 months prior to study Day 1
* Use of corticosteroids within 2 weeks prior to study Day 1
* Major surgery within 6 months of study Day 1
* Subjects with any history of severe gastroparesis
* Inability or difficulty swallowing whole capsules or tablets
* Women who are pregnant or breast feeding
TOPIK Study: A Study to Report Progressive Multifocal Leukoencephalopathy and Other Serious Opportunistic Infections in Natalizumab Treated Participants

The primary objective of the study is to estimate the incidence of progressive multifocal leukoencephalopathy (PML) and serious adverse events (SAEs) of other opportunistic infections (OIs) among all participants taking natalizumab. The secondary objectives of the study are to estimate the incidence of SAEs, to estimate the incidence of SAEs among participant subgroups defined by demographic and clinical factors (age, gender, duration of treatment, pregnancy, breastfeeding), to characterize and estimate incidences of malignancies, hypersensitivity reactions and John Cunningham Virus (JCV) positivity among all participants taking natalizumab, and to count and describe pregnancies and breastfeeding among participants previously exposed to natalizumab.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants starting with natalizumab after 1st January 2019 and participating in the ReMuS will be included in this study

Key Exclusion Criteria:

* Not Applicable (NA)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Surgical Septal Myectomy vs Percutaneous Transluminal Alcohol Septal Ablation in Patients With Hypertrophic Obstructive Cardiomyopathy

The aim of this randomized trial is to compare the improvement in exercise capacity among patients with highly symptomatic hypertrophic obstructive cardiomyopathy despite optimal medical treatment who undergo alcohol septal ablation (ASA) or surgical septal myectomy (SSM).

This is a prospective, multicentre, open label, randomized controlled, non-inferiority trial (RCT) with a 1:1 randomization to alcohol septal ablation or surgical septal myectomy in patients with hypertrophic obstructive cardiomyopathy (HOCM) between 40-75 year of age with symptoms and/or syncope due to HOCM despite medical therapy. A total of 100 patients will be included. All patients will be evaluated with bicycle ergometry exercise test, MRI and 2D-echo before and 1 year after invasive treatment. Follow-up will be at 1,3 and 5 years.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 40-75 years including 40 and 75 years of age
2. HOCM eligible for both SSM and ASA by a heart team (multidisciplinary team) and core lab.
3. Left ventricle outflow tract (LVOT) obstruction \> 30mmHg at rest or during physiological provocation by transthoracic echocardiogram
4. Symptomatic (New York Heart Association classification (NYHA) \>1 or Canadian Cardiovascular Society (CCS) class \>1) and/or syncope due to HOCM

Exclusion Criteria:

1. Unable to give informed consent
2. A life expectancy of less than 1 year
3. Concomitant (structural valve disease, aorta, rhythm, CABG) surgery during the same session
4. Not able to perform bicycle ergometry exercise test
Level of Physical Activities in Patients Before and After Breast Cancer Treatment

Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had already been treated at the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the level of physical activities was the International Physical Activities Questionnaire (IPAQ-short version), validated by the World Health Organization - Physical Activities and Health International Committee (1998).

Introduction: Breast cancer is the most common malignant neoplasy in women. The risk for breast cancer in a lifetime is high among north-american women, about one out of eight, with 66% of the cases occurring after menopause and 15% when women are under 40 years old. Published cohort studies show clear evidences that women who practice intense physical activities have the risk for breast cancer reduced. The risk reduction for these women is 70%, and 10% for those who practice physical activities at a low level. During adolescence and adult age, moderate to intense physical activities may protect against a future breast cancer development. But some questions still need to be answered: Were women with a breast carcinoma diagnosis already physically active during life? Were there changes in these physical activities after treatment? Why? Objectives: The aim of this study was to identify the level of physical activities in patients before and after breast carcinoma treatment, and to observe if there were changes in the level of these activities. Subjects and Methods: 303 patients who had already had the diagnosis of breast cancer and had already been treated at the Ambulatory of Botucatu School of Medicine were selected. The measuring tool used for the level of physical activities was the International Physical Activities Questionnaire (IPAQ-short version), validated by the World Health Organization - Physical Activities and Health International Committee (1998).

Eligibility Criteria:
Inclusion Criteria:

* Patients whit diagnosis of breast cancer
Effect of Carnosine on Diabetes and Cardiovascular Risk Factors

Carnosine is a naturally occurring compound with a potential health benefits. In animal studies, carnosine supplementation reduces manifestation of chronic civilization diseases, regulates subclinical inflammation, protein glycation and lipid \& glucose metabolism. Our preliminary data showed the relationship between insulin resistance and carnosine content in human skeletal muscle. Based on these unique results we plan to perform intervention study aimed at identifying effects of carnosine on insulin sensitivity and secretion, which might reduce the development of T2D in obese. Similar metabolic effects of vitamin D3 were associated with expression of specific miRNAs. Circulating miRNAs related to carnosine action are unknown. The putative positive effects of carnosine on insulin sensitivity and secretion in obese patients might have a tremendous impact in prevention of type 2 diabetes. Identification of miRNAs associated with carnosine action could provide predictors of successful therapy.


Eligibility Criteria:
Inclusion Criteria:

* BMI (28-38 kg.m-2);
* waist circumference \>94 cm;
* % body fat 30%
* fasting glycemia \< 7 mmol/l

Exclusion Criteria:

* age \< 25 or \> 50 years,
* change in body weight \> 5 kg in last 12 months,
* obesity with BMI \> 38kg.m-2,
* previously or newly (oGTT) diagnosed type 2 diabetes,
* allergy, smoking, alcohol abuse, any pharmacotherapy including regular vitamin intake;
* cardiovascular, hematologic, respiratory, gastrointestinal, endocrine or oncologic diseases,
* kidney disease, acute inflammatory disease.
MOWOOT Device Treatment for Adults with Chronic Constipation

The primary objective is to compare the effectiveness of the experimental Intermittent Colonic Exoperistalsis (ICE) treatment with MOWOOT, with the active control of trans-anal irrigation (TAI) as standard-of-care. The secondary objectives are to further compare the ICE treatment with MOWOOT to the TAI standard-of-care clinically and economically.

The RCT will assess clinical effectiveness by means of quantitative and qualitative variables, and the cost effectiveness by means of economic outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Any gender 18 years or older
2. Symptoms meeting the American College of Gastroenterology definition of chronic constipation: unsatisfactory defaecation characterized by infrequent stool, difficult stool passage or both for at least previous 3 months
3. Bothered by their constipation
4. PAC-QOL ≥1.8
5. Using TAI for at least 3 months
6. Able to undertake the treatment with TAI or with the device themselves or with a carer willing to do it
7. Able to understand the study requirements
8. Able to understand written and spoken English (due to questionnaire validity)
9. Able and willing to provide written informed consent to participate

Exclusion Criteria:

Disease phenotype exclusion criteria:

1. Irritable Bowel Syndrome with Diarrhoea (IBS-D) or alternating constipation and diarrhoea (IBSmix): (not due to laxative use)
2. Inflammatory Bowel Disease (IBD)

   Device-related exclusion criteria:
3. Abdominal perimeter ≤65cm or ≥130cm
4. Unable to independently use the MOWOOT or TAI technology, unless a carer is available daily to assist

   Other medical conditions, medications and contraindications:
5. Previous large bowel resection
6. The presence of a stoma
7. External rectal prolapse
8. Active anorexia or bulimia
9. Active abdominal cancer
10. Large inguinal or umbilical hernia
11. Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable
12. Pregnancy or attempt to become pregnant in the next 6 months
13. Use of strong opioids\*
14. Use of antidepressants, bladder stabilisers or any other medication inducing, or treating, constipation unless used at a stable dose for at least 4 weeks before Screening Visit (this excludes laxatives which may be used as required up to three days before the screening visit)
15. Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 months
16. Participation in another parallel interventional clinical trial or less than 2 months from participation in a previous interventional clinical trial
17. Planned surgery for constipation if it might be within trial dates
Comparison of Transfers of Fresh and Thawed Embryos in Patients With Prior Failed Embryo Transfer Cycles

This study seeks to determine if patients with a history of failed fresh embryo transfer(s) will have increased success rates with embryo cryopreservation and subsequent thawed embryo transfer when compared to fresh embryo transfer.

Implantation failure remains a significant problem in cycles of in vitro fertilization (IVF). Patients with a history of implantation failure in fresh autologous cycles have been shown have reduced chance of success in subsequent fresh autologous cycles. A potentially frequent cause of implantation failure is reduced endometrial receptivity following ovarian stimulation, perhaps due to the effects of supraphysiologic hormone levels on endometrial development. Therefore, such patients may have a greater chance of success if all of their embryos are cryopreserved for use in a subsequent cycle in which endometrial development can be more carefully controlled, absent the effects of ovarian stimulation. Therefore this study compares success rates in cycles of fresh embryo transfer and cycles with transfer of frozen-thawed embryos.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 40 years
* Cycle day 3 FSH less than 10 IU/l
* At least 8 antral follicles
* At least one previous autologous embryo transfer cycle that did not result in ongoing pregnancy at 10 weeks.

Exclusion Criteria:

* Embryo biopsy
* Any prior fresh embryo transfer that resulted in live birth