cyrilzakka/clinical-trials huggingface dataset:
Preventing Recurrent Gestational Diabetes With Metformin

Study Hypothesis: Intervention with metformin therapy early in pregnancy will prevent gestational diabetes mellitus recurring in previously affected pregnancies.

Gestational diabetes mellitus (GDM) is a common medical complication of pregnancy and is associated with increased risks to mother and baby. The incidence is increasing reflecting changing pre-gravid female demographics. Once one pregnancy is complicated by GDM, subsequent pregnancies are more likely to be affected by the same condition. This reported risk of recurrence is estimated to range between 35 and 80%, with non-caucasian ethnicity being the strongest predictor of GDM recurrence. Evidence regarding further predictors of recurrent GDM is conflicting and measures that might prevent recurrence need exploring.

Metformin is commonly used in the treatment of established GDM and has been shown to reduce the incidence of GDM in the context of polycystic ovarian syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy;
* 8-22 weeks gestation
* Previous pregnancy complicated by gestational diabetes

Exclusion Criteria:

* Established pre-existing diabetes (including unrecognised diabetes defined as a fasting plasma glucose ≥ 7.0mmol/L and/ or HbA1c ≥ 48mmol/mol); Contraindications to metformin therapy (creatinine ≥ 130μmol/L/ alanine transaminase ≥ 2.0 x upper limit normal/ previous intolerance to metformin)
* Planned continued antenatal care/ delivery at centre not included in trial
* Planned fast for cultural/ religious reasons e.g. Ramadan
Efficacy and Safety of DLBS3233 in Subjects With New Onset of Type 2 Diabetes Mellitus

This is a 2-arm, double-blind, parallel, randomized, placebo-controlled clinical study, with 12 weeks of therapy to evaluate the efficacy and safety of DLBS3233 in improving metabolic control in newly diagnosed type-2-diabetic patients, as measured by A1c level, fasting and 2-hours post-prandial plasma glucose, fasting insulin level, HOMA-IR, HOMA-B, adiponectin level, lipid profile, and body weight.

There will be two groups of treatment in this study who will receive DLBS3233 or placebo of DLBS3233 (with lifestyle modification) for 12 weeks of therapy.

Clinical and physical examination to evaluate the efficacy and safety as well as measurement of fasting and 2-hour post-prandial plasma glucose level will be performed at baseline and every 6-weeks-interval. Other clinical and laboratory examinations will be performed at baseline and at the end of study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with age of 18-60 years
* BMI ≥ 18.5 kg/m2
* Newly diagnosed (new onset of) type 2 DM subjects, defined as FPG level of ≥ 126 mg/dL or 2h-PG level of ≥ 200 mg/dL or A1c of ≥ 6.5%)
* FPG ≤ 183 mg/dL
* Hemoglobin level of ≥ 10.0 g/dL
* Serum ALT ≤ 2.5 times upper limit of normal
* Serum creatinine \< 1.5 times upper limit of normal

Exclusion Criteria:

* Female of childbearing potential
* Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment
* Uncontrolled hypertension (SBP \> 160 mmHg and/or DBP \> 100 mmHg)
* History of renal and/or liver disease
* History of or the presence of any clinical evidence of malignancies
* Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections
* Current treatment with systemic corticosteroids or herbal (alternative) medicines
* Participation in any other intervention trial within 30 days prior to Screening
Does PTH 1-34 (Teriparatide) Enhance Spinal Fusion in Humans?

Parathyroid (PTH) hormone has been shown to enhance fracture healing in animal studies. There are so far only three published papers concerning humans. Postero-lateral fusions have shown a healing rate of less than 50% after bone. The purpose of this study is to determine if PTH 1-34 (teriparatide) improves the healing rate and the clinical course after spinal stenosis surgery.

100 patients undergoing surgery due to spinal stenosis and intraoperatively treated with autologous bone graft, will be randomised to either 4 weeks of daily injections with teriparatide or control.

Primary outcome: The rate of healing at 6 months on CT Scans. Secondary outcomes; Pain (VAS), function (Oswestry Disability Index), quality of life (EQ-5D) at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* lumbar spinal stenosis operated on with decompression and bone grafting. All ages are accepted, but women must be postmenopausal.

Exclusion Criteria:

* •dementia or psychiatric disorder

  * known malignancy \< 5 years prior to fracture
  * calcium above reference value
  * signs of liver disease
  * creatinine over ref. value
  * inflammatory joint disease
  * alcohol or drug abuse
  * oral corticosteroid medication
  * long-term NSAID-treatment (=\> 3 months prior to fracture)
The Use of Self-reported Symptoms as a Proxy for Acute Organophosphate Poisoning Among Nepali Farmers

The purpose of this study is to evaluate self-reported symptoms as a proxy for acute organophosphate poisoning by examining self-reported acute organophosphate poisoning symptoms and PchE activity in response to occupational acute organophosphate exposure among farmers in Nepal.


Eligibility Criteria:
Inclusion Criteria:

* male
* minimum age 18 years
* hand pressured backpack sprayer usage
* used to spray with moderately to extremely hazardous pesticides according to the World Health Organization's (WHO) Pesticide Hazard Classification

Exclusion Criteria:

* usual personal protective equipment use (respirator/mask with particulate filter, face shield, googles, gloves, boots, plastic poncho)
* unwilling to stay pesticide-free seven days prior to each of the two spray sessions
* medical conditions interfering with PchE activity (liver disease, acute infection, chronic malnutrition, heart attack, cancer, obstructive jaundice, inflammation caused by various diseases, or use of pyridostigmine drugs)
Nurse Intervention Project

The use of interventions for cancer-related distress is important to reduce this distress. Distress has a negative impact on quality of life, the recovery during and after treatment and may even adversely affect survival. There is insufficient attention to the systematic approach to psychosocial problems in cancer patients in the Netherlands. A task force discussed and studied which instrument measures psychosocial problems best. The distress thermometer ("lastmeter") had the best results. A guideline is written to use the distress thermometer for patients with cancer and will be used in hospitals in the Netherlands. However, it is not clear what the effects are of the use of the distress thermometer on the psychosocial wellbeing of the patient. Furthermore, it is also unknown whether the use of the distress thermometer leads to cost-effective care. The study focuses on the use of the distress thermometer in breast cancer patients. An efficiency study (RCT) will be conducted to evaluate the systematic use of the distress thermometer and its discussion by a nurse as compared to the usual care provided to outpatients who are treated with curative intent for breast cancer by their treating physicians. The clinical and economic impact of the use of the Distress thermometer will be assessed in comparison with usual care.The recruitment of patients will take place in the out-patient clinic of a university hospital. Patients will be followed from diagnose until two years after finishing their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven malignancy of the breast
* Curative treatment
* Dominated the dutch language
* Age \> 18 year

Exclusion Criteria:

* Previously treated for a malignancy
* Psychiatric problems that adherence this study
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 Co-administered With Trimethobenzamide Hydrochloride in Healthy Subjects

This study will test the hypothesis that PF-06649751 with continuous co-administration of trimethobenzamide hydrochloride (TMB) with will be safe and well tolerated. Single doses of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose projected to be under the current limits for drug concentration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study medication (whichever is longer).
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Comparison of Two-hand Mask Ventilation Technique: Standard V-E Versus Reversal V-E Technique

This study hypothesizes that a novel reversal V-E ventilation technique will retain its high efficiency as that of standard V-E technique and will be easier to use.

Despite advances in intubation technology, difficult airways persist. Because it is failure to oxygenate, not failure to intubate, that ultimately leads to brain injury and cardiovascular collapse, effective mask ventilation is at least as important as successful intubation. Therefore optimizing mask ventilation is crucial for clinicians. When difficult mask ventilation encounters, clinicians often switch to two hand technique to hold the mask including either "C-E" clamp or "V-E" clamp. Both volume mode ventilation and pressure mode ventilation are superior with the V-E technique as compared to the C-E technique. The study will test the hypothesis that a novel reversal V-E mask ventilation technique will retain its high efficiency as that of standard V-E technique but be easier to use than standard V-E technique.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Requiring general anesthesia
* BMI =\>30

Exclusion Criteria:

* Untreated ischemic heart diseases
* Respiratory disorders, including COPD and asthma
* American Society of Anesthesiologists(ASA) physical class of 4 or greater
* Undergoing emergency surgery
* Requiring rapid sequence intubation for aspiration protection
* Non propofol - induction of anesthesia
* Requiring fiberoptic intubation
* Pregnant women or women who have given birth within the last month
Topical Nitro or Placebo Pre-Cath

Phase 2, single-center, randomized, blinded clinical study to assess the safety and efficacy of topical nitroglycerin on ease of TRA during scheduled PCI. We will compare topical nitroglycerin to placebo applied prior to planned, non-urgent PCI to determine if nitroglycerin is associated with decreased number of arterial puncture attempts made, decreased time to radial access, and lower crossover rate to TFA. Subjects will be randomized to receive either topical nitroglycerin ointment or placebo prior to scheduled PCI. There will be 256 subjects enrolled in this study with 1:1 randomization.

Percutaneous coronary intervention (PCI) procedures performed by entering the radial artery, or the transradial approach (TRA), is associated with reduced vascular access site complications, bleeding, and length of hospital stay, as well as greater patient satisfaction when compared to the transfemoral approach. One of the major challenges to a successful TRA remains the small size of the radial artery. The potential need for larger catheters during PCI has been one factor limiting broader adoption of TRA and a common reason for crossover from TRA to femoral access intraprocedurally. Additionally, multiple unsuccessful attempts to access the radial artery leads to unnecessary bleeding and may lead to severe arterial vasospasms. Nitroglycerin, a vasodilator, is available in a topical form and may be used prior to PCI to dilate the radial artery and potentially increase the rate of successful TRA.

Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant female \> 18 years of age at the time of consent
2. Scheduled to undergo PCI using TRA in the cardiac catheterization laboratory
3. Able to provide informed consent with capacity, given in English.

Exclusion Criteria

Patients with any of the following characteristics or conditions will not be included in the study:

1. Known nitrate allergy
2. Allergy to CeraVe Moisturizing lotion
3. Baseline hypotension with systolic blood pressure \<90mmHg
4. Absence of radial artery blood flow in one or both arms
5. Presence or history of liver, rheumatologic, or chronic kidney disease
6. Current treatment with any vasodilator therapy (eg. Sildenafil)
7. Radial artery catheterization \<30 days prior to enrollment
8. Active site infection
9. AV-fistula or prior radial artery harvest for bypass surgery
A Trial of 0.025 Wire Guided Cannulation Versus Current Practice 0.035 Wire Guided Cannulation

The aim of this study is to determine whether using a smaller wire results in a higher success rate at endoscopic retrograde cholangiopancreatography (ERCP), and lower incidence of adverse events

Cannulation of the bile duct is a prerequisite to successful therapeutic biliary endoscopy. Cannulation itself can carry substantial risk to the patient. Acute pancreatitis following ERCP can occur up to 5% of cases. The risk increases in patients with non dilated bile ducts, young age, known past history of pancreatitis and suspected sphincter of oddi dysfunction. During the procedure of ERCP, the number of pancreatograms also correlates with incidence of post ERCP pancreatitis. Hydrostatic pressure by contrast injection into the pancreatic duct may be the principal cause of pancreatitis. We performed a meta-analysis of randomized controlled trials that compared the technique of contrast guided to wire guide cannulation in achieving bile duct cannulation during ERCP and found that wire guide cannulation was better at the prevention of post ERCP pancreatitis. The use of a guide wire obviates the need for contrast injection. The current standard is the use of a 0.035" guidewire with a hydrophilic tip. We now postulate that the use of a 0.025" further reduces post-ERCP pancreatitis as a finer wire theoretically induces less trauma to the pancreatic orifice.

Eligibility Criteria:
Inclusion Criteria:

* All patients referred for ERCP who have an intact naïve papilla are considered for inclusion

Exclusion Criteria:

* Age \<18yrs
* Acute illness (hypotension: BP\<90mmHg, hypoxia: O2 \<95%, haemodynamic instability)
* Inability or refusal to give informed consent.
* Patients with previous sphincterotomy
* Pancreatic or ampullary cancer are excluded as post-ERCP pancreatitis (PEP) is very uncommon in these subgroups and tumour-related anatomical variation may alter cannulation technique.

(consider substratify results for this subgroup, but exclude if duodenal stenosis precludes an attempt on the papilla)

* Patients with surgically altered anatomy (Bilroth II gastrectomy and Roux en Y anastomosis) are excluded as cannulation technique is fundamentally different from that in normal anatomy.
Genome-wide Association Study

To explore biomarkers predictive of clinical response to Taxane/5-FU/platinum based chemotherapy in esophageal squamous cell carcinoma. To identify negative predictive markers to 5-FU/platinum/Taxane. To elucidate signal transduction pathway attributable to 5-FU/platinum/Taxane resistance. To analyze correlation between the quantity of circulating tumor cells and circulating endothelial cell precursors and treatment response to Taxane/5-FU/platinum based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmed esophageal squamous cell carcinoma
* Patients treated with Taxane or 5-FU or platinum based chemotherapy.
* provision of a signed written informed consent.

Exclusion Criteria:

* patients not signed written informed consent.
* patient unacceptable for study in the judgement of the investigator.
Cardiac RadiothErapy For hEart faiLure

Preliminary data suggests that patients suffering from advanced refractory heart failure (HF) could benefit from single low dose whole heart external beam radiotherapy (EBRT).

Objective: To explore in our center the efficacy of administering a EBRT treatment of 5Gy to the whole heart in patients with advanced and refractory HF. The hypothesis is that 5Gy EBRT to the whole heart can improve the left ventricular ejection fraction (LVEF) of these patients by a clinically relevant 5%.

Main study endpoints: The primary aim is to explore the efficacy of EBRT treatment for advanced refractory HF. Secondary endpoints include an assessment of safety, overall survival, hospital admissions, late toxicity, quality of life and the effect of the treatment on other heart function indicators (left ventricular volumes, NT-proBNP, Troponine, High sensitive CRP).


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years
* Advanced refractory HF NYHA class II, III or IV
* Stable HF for the last 6 months with maximal guideline-directed HF therapy
* Ischemic or dilated cardiomyopathy
* LVEF at baseline ≤ 35%
* Ability to give a written informed consent and willingness to return for follow-up

Exclusion Criteria:

* Eligible or in consideration for heart transplantation
* Pregnancy or breastfeeding
* Previous radiotherapy with cardiac involvement
* Any condition that is deemed a contraindication in the judgment of the investigators
Nutritional Intervention of Type II Diabetes Mellitus by Vitamin D in Qatar

There is an association between elevated Type II Diabetes Mellitus (T2DM) risk and low serum levels of vitamin D. It is important to examine whether Vitamin D can enhance oral glucose tolerance in individuals at risk for developing T2DM. As such, the hypothesis suggested is that Vitamin D supplementation (4,000 IU/day) for 24 weeks in pre-diabetic individuals will decrease insulin resistance and the associated metabolic indices linked to the later development of T2DM.

Epidemiologically, there is an association between elevated T2DM risk and low serum levels of vitamin D and suggest that it may protect against the diseases through the improvement of insulin sensitivity as well as secretion and reducing chronic inflammation. Although some of these effects were shown in clinical studies, no study permitted the inference that vitamin D can reduce blood glucose and attenuate inflammation. Post-prandial glucose is the most sensitive to alterations in insulin sensitivity. Therefore, it is rational to examine whether vitamin D can enhance oral glucose tolerance in individuals at risk for developing T2DM and to elucidate the mechanism by which this occurs, i.e. via improved insulin sensitivity or improved insulin secretion, or both. Furthermore, identifying a distinct proteomics-based signature that can be used to distinguish responders to supplementation from non-responders is critical to define the bases for inter-individual variation in response and the effect of vitamin D on the prevention of T2DM. Identification of this proteomics-based signature will enable us to tailor alternative preventive measures to adjust the vitamin D dose to non-responders, leading to more effective and precise intervention protocols.

Eligibility Criteria:
Inclusion Criteria:

* male or non-pregnant, non-lactating females, aged 18-75
* volunteered to participate by signing the consent form
* BMI ˂ 40kg/ m2
* serum 25(OH) vitamin D3 (25(OH)D) concentration ˂75nmol/L
* fasting serum glucose \<7.0 mmol/L
* HOMA insulin resistance index ≥1.3
* presence of any ONE OR MORE of the following risk factors for type 2 diabetes:

  * high BMI (\>23)
  * high waist circumference according to IDF ethnic specific values for non- Caucasian (females \>80cm; males \>90cm)
  * family history of diabetes in first-degree relative (parent or sibling)
  * previous history of gestational diabetes
  * history of high blood glucose, high triglycerides and/or low HDL cholesterol

Exclusion Criteria:

* fasting serum glucose ≥7.0mmol/L
* history of renal failure or liver disease
* serum urea or creatinine \>1.8 times upper limit of normal (ULN)
* serum aspartate or alanine transaminase (AST,ALT) \>1.5 times ULN
* current use of drug or drugs to treat diabetes or which influence glucose metabolism
* medical or surgical event requiring hospitalization within 3 months of randomization
* presence of any condition affecting nutrient absorption
Epidural Volume Extension and Intrathecal Use of Local Anesthetics in Cesarean Sections

Intrathecal (i.t.) administration of isobaric bupivacaine, ropivacaine and levobupivacaine with addition of fentanyl for c-section either combined or not with administration of 10 ml of N/S 0,9% epidurally, in order to extent epidural space.Sensory and motor block profile, haemodynamics and side effects were assessed.

Parturients scheduled for elective caesarean section are randomly allocated to 6 groups: they receive double-blindly intrathecal isobaric bupivacaine 10 mg ( Group B), ropivacaine 15mg (Group R) , levobupivacaine 10mg (Group L) combined with 10 μg fentanyl and followed by epidural administration of 10 ml of N/S 0,9% respectively, and isobaric bupivacaine 10 mg ( Group BupivacaineF), ropivacaine 15mg (Group RopivacaineF) , and levobupivacaine 10mg (Group LevobupivacaineF) combined with 10 μg fentanyl without epidural administration of 10 ml of N/S 0,9%. Clinical endpoints are the sensory and motor block profile, haemodynamics (arterial pressure, heart rate) and side effects.

Eligibility Criteria:
Inclusion Criteria:

* Elective cesarean section
* ASA I-II

Exclusion Criteria:

* complicated pregnancy (i.e preeclampsia, eclampsia,arterial hypertension, diabetes mellitus)
* abnormal fetal heart rate at the time of admission
* body mass index \> 35 kg/m2
* height \<150cm and \>185 cm
* age \<18 yrs and \>40 yrs
* patients with contraindication to spinal anaesthesia( i.e anticoagulants)
* ASA \>III
* intraoperative excessive bleeding
* patients with previous psychiatric diseases