cyrilzakka/clinical-trials huggingface dataset:
Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.

This study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.

Eligibility Criteria:
Inclusion Criteria:

* women delivering at home with a trained study provider who are able to provide informed consent

Exclusion Criteria:

* women with known contraindications to prostaglandins
Reha Drive: Predictors of Fitness to Drive a Car for Cardiologic Patients and Determination of Vital Signs

In this study predictors of fitness to drive a car in cardiologic patients after acute intervention and discharge from hospital to home or rehabilitation are determined in addition to possible automotive monitoring of vital signs via contact less sensors.

Increasing numbers of elderly people with cardiovascular diseases and the wish to drive a car need recommendations corresponding to fitness of driving after their discharge from hospital to home or rehabilitation. A policy paper of the German Cardiac Society (DGK) of 2010 discusses the aptitude of driving a car of cardiovascular patients on experience but only little trial data.Therefore predictors of reduced fitness to drive a car are determined via medical data in comparison to data elevated while "driving" in a simulator and evaluated via Lane Change Test (LCT). Also monitoring of the fitness of driving in the car, automotive monitoring via contactless sensors, could be helpful for judgement.Therefore possible evaluation of heart and breathing rate will be examined with contactless measurements via video camera.

Eligibility Criteria:
Inclusion Criteria:

* cardiologic disease after acute event (e. g. myocard infarction, bypass surgery, device implantation)
* rehabilitation in clinic "An der Rosenquelle"

Exclusion Criteria:

* dementia
* lack of language ability
* pregnancy
Enduring Happiness and Continued Self-Enhancement

Over the past several decades, a new science of subjective well-being has produced insights into the factors that make people happy-from cultivating strong relationships to pursuing the right goals. Drawing on these empirical findings, the investigators created a comprehensive 12-week intervention program, ENHANCE: Enduring Happiness and Continued Self-Enhancement. The investigators multimodal program is designed to teach people essential skills in order to produce sustainable changes in behavior and, as a result, long-lasting increases in happiness. To test the effectiveness of ENHANCE, the investigators designed a six-month randomized clinical trial. Participants will be assigned to an active treatment group or a waiting group control. They will complete baseline assessments, and follow-up assessment at three and six months after the start of the intervention. These assessments will contain measures of subjective well-being and objective measures of health, as well as a variety of psychological mediators (e.g., psychological needs) and moderators (e.g. personality). The investigators will thus be able to explore not only whether ENHANCE works to improve well-being, but also why and how ENHANCE works.


Eligibility Criteria:
Inclusion Criteria:

• Participants ages 25 to 75

Exclusion Criteria:

• Major Depression
Effect of Deep Neuromuscular Block on Surgical Conditions in Morbidly Obese Patients

This is a randomized control trial (RCT) that studies the surgical conditions during moderate and deep neuromuscular blockade in 100 morbidly obese patients receiving elective laparoscopic surgery for bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* BMI \> 34 kg/m2
* Elective bariatric surgery.

Exclusion Criteria:

* Known or suspected neuromuscular disorders impairing neuromuscular function
* Allergies to muscle relaxants, anesthetics or narcotics
* A(family) history of malignant hyperthermia
* Women who are or may be pregnant or are currently breast feeding
* Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output \< 0.5 ml/kg/h for at least 6 h.
Virtual Reality Exposure Therapy in the Intensive Treatment of Social Anxiety Disorder

To explore the efficacy of drugs combined with virtual reality exposure therapy in the treatment of phobias compared with single drug treatment.


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for phobias in DSM-IV.
* Age from 18 to 45 years old.
* Graduated from junior high school or above.
* No serious physical disease, no serious visual impairment, and no family history of mental illness.

Exclusion Criteria:

* Exclude other psychiatric diagnosis and treatment history.
Benefit of Immunoprophylaxis on Fibrosis to Reduce Viral Load After Liver Transplantation

An open-label randomized multicenter clinical study comparing three regimes of immunosuppression : (A) tacrolimus and steroids, (B) antithymocyte induction therapy and full dose of tacrolimus, (C) antithymocyte induction therapy with mycophenolate mofetil and a reduced dose of tacrolimus.


Eligibility Criteria:
Inclusion Criteria:

* patients who received a first liver transplantation,
* presenting with a qualitative or quantitative PCR positive for hepatitis C virus at time of transplantation, whatever the transaminase activity,
* Women of childbearing potential with a negative pregnancy test,
* Male or female patients who agree to use an effective method of contraception,
* patients who signed a written informed consent form to participate in the study,
* patients who are compliant and likely to follow the visits specified by the study protocol

Exclusion Criteria:

* • Preoperative serious renal impairment (serum creatinine levels \> 200 µmol/l),

  * repeat transplantation,
  * multiple organ transplantation,
  * transplantation performed with an organ transplant obtained from a living donor or a reduced or shared organ grafts,
  * serious concomitant disorder,
  * positive serology for HBs antigen or HIV positive at time of enrollment,
  * previous history of nonhepatic cancer (except for localized skin cancer),
  * presence of a hepatocellular carcinoma, for which the primary lesion exceeds 5 cm or is complicated by portal thrombosis or metastatic disease,
  * an investigational product or therapy administered less than one month before entry into the study.
Near-Infrared Fluorescent Sentinel Lymph Node Mapping for Breast Cancer

Sentinel lymph node (SLN) mapping is the standard of care for the surgical staging of breast cancer. We propose a method of SLN mapping based on the use of invisible near-infrared fluorescent light that has significant advantages for both patient and surgeon. The present study is a 6-patient pilot study designed to optimize clinical workflow with the new imaging system.

The standard of care in breast cancer surgery includes identification and assessment of the sentinel lymph node (SLN). At the present time, SLN mapping utilizes a gamma ray-emitting radiotracer and/or a blue dye. Radiotracers provide sensitive detection of SLNs, but require involvement of a nuclear medicine physician, vary widely in transit time depending on the agent employed, can be difficult to localize with a handheld gamma probe, and expose both patient and caregivers to ionizing radiation. Blue dyes, such as isosulfan blue, cannot be seen easily through skin and fat, but can aid in definitive identification of the SLN when the handheld gamma probe gives ambiguous results. Finally, the learning curve associated with expertise in the SLN procedure is quite long using currently available techniques.

In this 12-patient pilot study, we are testing a new intraoperative imaging system that we developed for image-guided surgery. The imaging system uses invisible, near-infrared (NIR) light to visualize lymphatic flow and to identify the SLN. The imaging system makes no contact with the patient and can display surgical anatomy simultaneously with NIR fluorescence.

All patients will receive the standard of care for SLN mapping, namely technetium-99m sulfur colloid lymphoscintigraphy. In addition, patients will be injected with indocyanine green (ICG) diluted in human serum albumin (HSA). ICG is already FDA approved for other indications and is used in this study at 400-fold to 2000-fold lower than the typical clinical dose. Dilution into HSA improves the brightness of ICG by over 3-fold, making it an excellent tracer for lymphatic flow.

The purpose of this pilot study is to determine whether the ergonomics of the imaging system interfere with typical clinical workflow during breast cancer surgery. A secondary goal is to optimize the imaging parameters (light levels, exposure time, etc.) associated with identification of the SLN.

Eligibility Criteria:
Inclusion Criteria:

* Women or men above the age of 21 who have biopsy-proven breast cancer, and who are undergoing sentinel lymph node mapping for staging and treatment of their disease.

Exclusion Criteria:

* Pregnant women,
* Significant renal, cardiac, or pulmonary disease,
* History of iodine allergy.
The Role of Granulocyte Colony Stimulating Factor in Embryo Transfer Outcomes

The goal of this clinical trial is to test the effect of granulocyte colony-stimulating factor (G-CSF, A.K.A. Filgrastim) in infertility patients undergoing in vitro fertilization (IVF) treatment. The main question it aims to answer is:

Can in vitro fertilization-embryo transfer (IVF-ET) outcomes be improved by supplementing the transfer media with Granulocyte colony-stimulating factor (GCSF)?

Participants will undergo their embryo transfer as per the normal clinic protocol but will be randomized to either receive the standard embryo transfer media or the GCSG-supplemented transfer media.

Researchers will compare the GCSF and standard transfer media groups to see if clinical outcomes are improved (i.e., implantation rate, pregnancy, clinical pregnancy rate, live birth rate).

Please see uploaded study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Recruited subjects will either be undergoing a fresh IVF-ET cycle in which the embryo(s) generated from the initial treatment cycle are transferred during that same cycle (i.e., on day 5 or 6 post-egg retrieval) or an FET cycle in which the embryo(s) transferred were generated in a previous IVF cycle and were cryopreserved for subsequent warming and transfer.

Exclusion Criteria:

* Patients with uterine factor or severe male factor infertility will be excluded.
* Patients who have had previous IVF failures will be excluded.
A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation
* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm

Exclusion criteria:

* Malabsorption or other condition that would interfere with enteral absorption
* Active brain metastases
* Clinically significant cardiovascular dysfunction or liver disease
Randomized Controlled Trial to Evaluate the Impact of ZYN Nicotine Pouch Products on Cigarette Usage and BoExp in Adult Smokers Over a 12-week Period

To verify whether unrestricted access to flavored products is likely to lead to greater reductions in combustible cigarette smoking and decreased exposure to smoking related toxicants.

US adult smokers will be randomized into three groups (Group I: (control) continue smoking their usual brand of CC; Group II: provided with tobacco flavor and unflavored options of ZYN; Group III: provide with unrestricted flavor options of ZYN) to evaluate the impact of availability of different ZYN products on cigarette usage patterns and biomarkers of exposure over a 12-week study period, followed by an 6-week extension for some participants.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult smokers 22 to 65 years of age (inclusive) at screening.
* Smokes an average of at least 10 commercially available cigarettes per day for the last 12 months.
* Interested in switching from combustible cigarettes to nicotine pouch products.

Exclusion Criteria:

* Participants of childbearing potential (CBP) who are breast-feeding or have a positive pregnancy test.
* Participants who currently use nicotine pouches.
* Participants with known heart disease or medical condition that may adversely affect participant safety
The Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Proximal Humerus Fracture Patients

The aim of this study is to determine the diagnostic accuracy of ultrasonography (US) in detecting full-thickness (a lesion that extends through both the bursal and articular part of the tendon) rotator cuff tear in patients who have sustained a proximal humerus fracture, using operative examination as the golden standard.

Although most of the focus concerning proximal humerus fractures is on the bony structures, injuries in the musculotendinous insertion regions of the rotator cuff musculature may also need attention in the treatment. Ultrasound is a painless and non-invasive screening modality in patients with a suspected rotator cuff tear. It is a user-dependent modality and health professionals must possess the competence and training before using it. To the investigators knowledge, no studies have investigated the accuracy of ultrasound in detecting rotator cuff tears, in patients who sustained a proximal humerus fracture.

Eligibility Criteria:
Inclusion Criteria:

* Displaced proximal humeral fracture
* Referred to operative treatment

Exclusion Criteria:

* Younger than 18 years old
* Non-independent
* Does no understand written and spoken guidance in local language, Danish, Swedish or Finnish
* Open fracture
* Isolated tuberculum fracture
Ultrasound Guided Supracondylar Nerve Block & Hematoma Block for Closed Reduction of Distal End Radius Fractures

Comparison of analgesia between ultrasound guided supracondylar radial nerve block and hematoma block for closed reduction of distal end radius fractures- an observational study

A patient who presents to the emergency department with a suspected distal end radius fracture will be assessed with a baseline NRS score1 and given analgesics if needed. Further they will be sent for an x-ray. If the X ray-shows a distal end radius fracture a decision to give hematoma block or supracondylar radial nerve block will be taken as per the choice of the treating physician. Patients who do not meet the exclusion criteria are excluded from the study at this phase. NRS score 2 is assessed once again prior to block and a Hematoma block/ Supracondylar radial nerve block is given. Needle in and out time will be noted and the pain during needling is evaluated using the NRS score 3. Pain score will further be evaluated for every 10 mins after needle out time for a maximum of 30 mins or when the patient gets adequate analgesia ( NRS score 4a, 4b, 4c, 4d).

If the block is successful, the treating physician will proceed to fracture reduction. If the block is a failure the physician will go for a rescue analgesia. NRS score5 will be evaluated at this stage. Further a NRS score 6 will be assessed 15 minutes post reduction. An x-ray will be checked for the evaluation of the reduction procedure performed and the patient will be discharged or admitted as necessary. The patient will be further followed after 1 week for delayed complications.

Eligibility Criteria:
Inclusion Criteria:

1. Adults \> 18 years with distal end radius fracture requiring closed reduction in Emergency Department
2. Patient who legally consent for study

Exclusion Criteria:

1. History of allergy to local anesthetics
2. Pregnant or lactating women
3. Infection or burn with local anaesthetic at injection site
4. Patients having other fractures or significant injuries that are causing pain
5. Patients with hemodynamic instability which includes patients with GCS score less than 15 under influence of alcohol/ inebriated state.
6. Patients on anticoagulants
7. Patients with compromised neurovascular system
Safety Evaluation and Effect of Food Supplement Containing Dietary Fiber From Cassava on the Alterations of Physiological Parameters in Overweight Female Volunteers

This study is set up to determine the consumption safety and the effect of a food supplement containing dietary fiber from cassava on the alterations of physiological parameters including fasting blood sugar, HbA1c, insulin resistance, lipid profiles, atherogenic index, blood pressure and gut microbes in overweight female volunteers.

Cassava is one of the important industrial crops in Thailand. The leftover fiber of cassava is still valuable and can be used as a dietary fiber. The previous study demonstrated that dietary fiber containing cassava fiber was safe for consumption without any contamination of the cyanide and heavy metals. Moreover, the microbial contaminations were within the safety range. The toxicity study revealed that the LD50 of the cassava dietary fiber was more than 5 g/kg body weight (BW) and NOAEL was 3 g/kg BW. The NOAEL was used to calculate the human equivalent dose for determining the effect of cassava dietary fiber in a clinical study.

Cassava dietary fiber consists of water-insoluble fiber such as cellulose more than 50%. The previous study showed that insoluble fiber decreased the risk of type 2 diabetes and increased insulin release. Moreover, a high fiber diet also decreased the fasting glucose and HbA1C in type 2 diabetes volunteer. In addition, the effect of dietary fiber on the reduction of cholesterol was also reported. The previous study reported that the cassava dietary fiber could decrease the total cholesterol, triglyceride but increase high-density lipoprotein in a dyslipidemia rat model. Therefore, the cassava fiber might be the potential food supplement for the control of blood sugar and lipid profiles in human. However, less scientific data support the effect of cassava dietary fiber in human.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women age between 35-60 years old
* BMI 23-29.99
* Blood pressure \<140/90 mmHg
* Fasting plasma glucose \< 100 mg/dL

Exclusion Criteria:

* Presence of any chronic diseases
* Alcohol addict or consume more than 2 units/day
* Smoking more than 10 cigarettes per day
* Medication or herbal medicine usage within 1 month prior to the study
* Use any medication or food supplement which affect to outcomes
* Pregnant or breastfeeding women
* Athlete
A Comprehensive Intervention for Diabetes and Comorbid Depression in Primary Care

The study involves a 32-week randomized controlled trial in primary care of a comprehensive diabetic and depression intervention in patients with type 2 diabetes and comorbid MDD, compared to a group treated with usual care for MDD plus disease self-management and measurement-based care for diabetes.

The overarching goal of the study is to translate research-based treatment procedures that have been shown to improve outcomes for both DM and MDD for use in primary care. More specifically, the aims are: 1) to evaluate the benefits of CDDI in improving diabetic outcomes compared to usual care for MDD plus disease self-management for diabetes; 2) to evaluate the benefits of CDDI in improving depression outcomes compared to the UC for MDD treatment protocol; and 3) to evaluate the benefits of CDDI in terms of improved (1) cardiovascular risk factors (blood pressure, body mass index, lipids, and abdominal fat), (2) levels of exercise and better diet, (3) clinician and patient satisfaction with care, (4) fidelity to treatment guidelines, and (5) cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for single or recurrent nonpsychotic MDD, and whom the physician deems it necessary to start on an antidepressant.
* Meets clinical criteria for type 2 diabetes as follows: (1) on pharmacological treatment for type 2 diabetes and/or (2) fasting plasma glucose \> 126mg/dL on 2 separate occasions or an abnormal oral glucose tolerance test (OGTT) (2-hours post load glucose ≥ 200mg/dL).
* HbA1C \> 7
* Ability and willingness to provide written informed consent
* Hamilton Rating Scale for Depression (HRSD) score ≥ 14
* Not on antidepressant medication for at least 2 weeks prior to screen (or 6 weeks in the case of fluoxetine or monoamine oxidase inhibitors - MAOIs)

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Type 1 diabetes
* General medical conditions that contraindicate use of antidepressant medications
* Unstable medical illnesses, such as uncontrolled hypertension or symptomatic cardiovascular disease, such as congestive heart failure or angina
* Current or past psychotic disorders including bipolar disorder (I, II, or NOS), schizophrenia, or schizoaffective disorder; anorexia; bulimia
* High risk for being unable to complete the study due to hospitalization, suicide attempts, significant self-mutilation, or other self-injurious or destructive behavior
* Concomitant pharmacological or psychotherapeutic treatment including but not limited to anxiolytics, neuroleptics, mood stabilizers, and/or other agents without proven antidepressant efficacy; cognitive behavioral therapy; current use of other medications that would be contraindicated with antidepressant treatment, as determined by the study doctor
* History of current substance or alcohol dependence requiring detoxification within the last 6 months
* Currently suicidal or considered a high suicide risk
* Require inpatient treatment for their depression
A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus;
* treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for \>=12 weeks prior to screening;
* HbA1c \>=7.0% and \<=10% at screening;
* stable weight +/-5% for \>=12 weeks prior to screening.

Exclusion Criteria:

* type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;
* clinically significant diabetic complications;
* clinically symptomatic gastrointestinal disease;
* \>3 episodes of severe hypoglycemia within 6 months before screening.