cyrilzakka/clinical-trials huggingface dataset:
Pharmacodynamics and Pharmacokinetics Study of Existing DMPA Contraceptive Methods

This is a randomized, multi-center, parallel-group Phase I study to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150 mg/mL or 300 mg/2 mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.

This is a randomized, multi-center, parallel-group Phase I study with a primary objective to evaluate the pharmacodynamics (PD) of Medroxyprogesterone Acetate (MPA) after a single subcutaneous (SC) injection of 150mg/mL or 300mg/2mL Depo-Provera CI in the abdomen of women of reproductive age with a confirmed ovulatory baseline cycle.

Secondary study objectives are:

* To evaluate and compare the pharmacokinetics (PK) of MPA after a single SC injection of 150mg/mL or 300mg/2mL of Depo-Provera CI to two injections of Depo-subQ 104 administered 3 months apart
* To evaluate the relationship between serum MPA concentration and suppression of ovulation
* To evaluate and compare the safety, tolerability and acceptability of a SC injection of DMPA of different frequencies, doses and volumes

Eligibility Criteria:
inclusion

Women may be included in the study if they meet all of the following criteria:

* in good general health
* age 18 to 40 years, inclusive
* willing to provide informed consent and follow all study requirements
* not pregnant
* does not desire to become pregnant in the next 24 months
* regular menstrual cycle (24 to 35 days)
* confirmed ovulation by serum P ≥ 4.7 ng/mL in two consecutive samples during the pre-treatment phase of the study
* at low risk of pregnancy (e.g., sterilized, in exclusively same sex partnership, in monogamous relationship with vasectomized partner, abstinent, using non-hormonal IUD or condoms)
* has a body mass index of 18.0 to 35.0
* has hemoglobin ≥10.5 g/L

exclusion

Women will be excluded from participating in this study if they meet any of the following criteria:

* medical contraindications to DMPA use
* use of any of the following medications within 1 month prior to enrollment:

  * any investigational drug
  * prohibited drugs (per protocol)
  * oral contraceptives
  * LNG IUS or implant
* use of DMPA in the past 12 months
* use of a combined injectable contraceptive in the past 6 months
* recent pregnancy (within 3 months)
* current lactation
* ongoing or anticipated use of prohibited drugs (per protocol)
* known sensitivity to MPA
* plan to move to another location in the next 18 months
* any condition (social or medical) which in the opinion of the site investigator would make study participation unsafe, would interfere with adherence to study requirements or complicate data interpretation.
A Study to Compare Two Techniques for Pain Control After Bariatric Surgery

The purpose of this study is to compare the postoperative pain and other clinical outcomes in patients who, during bariatric surgery, will be injected with a local anesthetic (Ropivacaine) through two different techniques.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective bariatric surgery
* age ≥ 18 years
* signed informed consent

Exclusion Criteria:

* Pregnant or lactating women,
* known allergy to local anesthetics
* Chronic pain syndrome.
Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries

Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride solution. The cost-effectiveness of these methods will also be compared. About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted in school using portable dental lights and instruments to identify teeth that need caries prevention. The children will be randomly allocated to one of the three test or the control groups. Treatments will be provided in the study primary schools according to standard clinical protocols. Follow-up examinations will be carried out every six months for 30 months to assess whether the preventive methods are successful, i.e. no dental caries develops in the treated teeth. The findings of this study will be of great value to dentists and public health authorities in deciding on the most appropriate dental caries prevention programme for school children in China and other developing countries.


Eligibility Criteria:
Inclusion Criteria:

* school children in good general health
* have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries

Exclusion Criteria:

* children with major systemic disease or taking long-term medications
* not cooperative or refuse dental treatments
A Trial Testing Early Vs Late Onset of EPO Alfa Treatment in Lower Risk MDS

This is an open-label, randomized, multicenter, phase III study

Patients with baseline Hb comprised between 9 and 10.5g/dl will be randomized to receive EPO Alfa 60000 UI/week for at least 12 weeks:

* Either at diagnosis Or
* at the Hb threshold chosen for RBC transfusions (must be \< 9g/dl)

in this trial we will compare the early introduction of EPO alfa to the delayed introduction in lower risk MDS with non RBC transfusion dependent anemia.

At enrollment patients will be randomised in the 2 arms (early and delayed start of EPO alfa).

Treatment Regimen Epoetin alfa 60000 UI/week for at least 12 weeks

1. Early onset arm: early onset of EPO ALFA 60000 IU/week , at patient inclusion
2. Delayed onset arm: late introduction of EPO ALFA 60000 IU/week, whenever the patient reaches the level chosen RBC transfusions (based on age, comorbidities, anticipated tolerance of anemia).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. MDS according to WHO 2016 criteria, with low or int 1 classical IPSS
3. Non-RBC transfusion dependent anemia
4. Hb level between 9 and 10.5g/dl (at the center's lab)
5. Hb level should be at least 1g/dl higher than the Hb threshold chosen to start RBC transfusions based on age, comorbidities and predicted clinical tolerance of anemia (this transfusion threshold should be chosen between 8 and 9g/dl)
6. Serum EPO level \<500U/l
7. No other cause of anemia (including iron deficiency, vitamin B12 or B9 deficiency, hemolysis, hypothyroidism....)
8. Performance status \<=2

Exclusion Criteria:

1. Higher risk MDS (IPSS intermediate-2 or high)
2. Del 5q
3. Baseline Hemoglobin level \> 10.5 g/dl or \<9g/dl
4. Transfusion threshold (based on age , comorbidities...) \>9g/dl
5. Transfusion threshold less than 1 g/dl below baseline Hb level
6. RBC transfusion dependence. Patients may have received only one transfusion series for MDS prior to inclusion
7. CMML , if \>10 % BM blasts or WBC\>13.000/mm3
8. Uncontrolled hypertension
9. Uncontrolled cardiovascular disease including angina pectoris or cardiac failure
10. Renal failure: Creatinine clearance\<40ml/min (using MDRD formula)
11. Pregnancy (positive bettaHCG) or nursing
Diastolic Heart Failure Management by Nifedipine

Patients with heart failure with preserved ejection fraction have a equally high risk for mortality and re-hospitalization as those with reduced ejection fraction. Effective management strategies are critically needed to be established for this type of heart failure. These patients have more hypertensive and ischemic etiology than those with reduced ejection fraction. The investigators hypothesis is that Ca channel blocker nifedipine can improve the heart failure clinical composite response endpoint compared with the conventional treatment in patients with heart failure with hypertension and/or coronary artery disease and preserved ejection fraction (\>=50%) by echocardiography. This study is multi-center, prospective, randomized, open-label, and blinded-endpoint design.


Eligibility Criteria:
Inclusion Criteria:

1. 20 years and older
2. Heart failure with history of hypertension and/or coronary artery disease
3. LVEF \> or = 50% on echocardiography

Exclusion Criteria:

1. Valvular heart diseases with significant regurgitation and/or stenosis
2. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and active myocarditis
3. Constrictive pericarditis
4. Cardiogenic shock
5. Planned coronary artery bypass grafting or percutaneous coronary intervention within 3 months
6. History of acute coronary syndrome or stroke within 3 months
7. Pregnancy or breastfeeding
8. Hypersensitivity or contraindication to nifedipine
9. Inability to obtain informed consent
10. Any conditions not suitable for the participation in this trial judged by the investigator
VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)

The goal of this project is to test the effects of the VibraCool mechanical stimulation neuromodulatory therapeutic device on post-operative pain and opioid use following anterior crucitate ligament reconstruction (ACLR), and thus residual opioids in circulation.


Eligibility Criteria:
Inclusion Criteria:

* Underwent ACL reconstruction

Exclusion Criteria:

* Pediatric iliotibial band ACL reconstruction (known to cause significantly more pain)
* Non-english speakers (limitations of our study group)
Lifestyle Change and Quality of Life in Obese Patients With Stage I/II Endometrial Cancer in Remission

RATIONALE: Exercise and dietary counseling may affect weight loss and improve the quality of life of obese endometrial cancer patients and may help them live longer and more comfortably.

PURPOSE: This randomized clinical trial is studying the effects of exercise and dietary counseling on weight loss and quality of life of obese patients with stage I or stage II endometrial cancer in remission.

OBJECTIVES:

Primary

* Determine the combined effect of exercise and dietary counseling on the weight loss and quality of life of obese patients with stage I or II endometrial cancer in remission.

Secondary

* Determine the feasibility and acceptability of lifestyle interventions in these patients.

OUTLINE: This is a randomized, controlled study. Patients are stratified according to age and body mass index (25-29.9 vs ≥ 30). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients undergo weekly contact with a dietitian; exercise intervention for 6 months; and physician counseling at baseline and at 3, 6, and 12 months. Patients undergo quality of life assessments and clinical assessments at baseline and at 3, 6, and 12 months.
* Arm II: Patients undergo quality of life, exercise, and clinical assessments at baseline and at 3, 6, and 12 months.

After completion of study treatment, patients are followed at 1 year.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed endometrial cancer meeting the following criteria:

  * Stage I or II disease
  * Post-operative total abdominal hysterectomy and bilateral salpingo-oophorectomy
  * Disease in remission
* Body Mass Index (BMI) ≥ 25

PATIENT CHARACTERISTICS:

Performance status

* ECOG 0-2

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

PRIOR CONCURRENT THERAPY: Not specified
Buzzy® Application in Pain

The research was conducted as a randomized controlled experiment to investigate the effect of Buzzy® on pain level during the measles-rubella-mumps (MMR) vaccine injection in 12-month-old infants. This study was done with infants meeting the sampling criteria (buzzy group: 30, control group: 30) on November 2018-May 2019 in Istanbul Bakirkoy 9 Family Health Center.

To determine the effect of Buzzy® application on pain, which is a combination of cold and vibration, during measles-rubella-mumps (MMR) vaccine injection administration on 12-month-old infants. The study is a randomized contrlled experimental research. The research sample is composed of 60 infants (buzzy:30, control:30) who are 12-month-old injected MMR vaccine at Bakırköy No. 9 Family Health Center between November 2018-May 2019. As a data collection tool Data Collection Form, FLACC Pain Scale and Buzzy® device have been used. While Buzzy® was applied on infants in the trial group before, during and after the vaccine injection, the infants in the control group were applied routine vaccine injection. The pain response of the infants was evaluated by the nurse and the parent before, during and after the vaccine injection and the physiological parameters were evaluated by the nurse before and after the vaccine injection.

Eligibility Criteria:
Inclusion Criteria:

* The baby has completed 12 months,
* MMR vaccine will be applied,
* Being at a suitable weight for the month,
* The baby has not been given analgesic medication during the day,
* It can be listed as the parent's willingness to participate in the research.

Exclusion Criteria:

* It can be listed as having a body temperature above 37.5.
Clarithromycin Resistant Tailored Therapy

1. Back ground Antibiotics resistance of Helicobacter pylori, especially to clarithromycin is one of the main causes of failure of eradication. 23S rRNA point mutation of Helicobacter pylori is associated clarithromycin resistance
2. Hypothesis If the investigators check the 23S rRNA point mutation then choose treatment regimens containing a proton pump inhibitor and combination of two antibiotics (amoxicillin and clarithromycin or metronidazole), the investigators will eradicate Helicoabacter pylori more successfully
3. Material \& methods The investigators enroll patients diagnosed with peptic ulcer, endoscopically. Helicobacter pylori is documented with Urea breath test or silver staining biopsy specimen or polymerase chain reaction of biopsy specimen. Check the 23S rRNA A2142G/A2143G point mutation by polymerase chain reaction. If there is mutation, the investigators consider as resistance to clarithromycin and choose the treatment regimen containing a proton pump inhibitor, amoxicillin, metronidazole. If there is no mutation, choose the treatment regimen containing a proton pump inhibitor, amoxicillin, clarithromycin. Verify Helicobacter pylori eradication by urea breath test. Compare eradication rate with conventional treatment,proton pump inhibitor, amoxicillin, clarithromycin.


Eligibility Criteria:
Inclusion Criteria:

* 20 - 75 years old
* Peptic ulcer (gastric ulcer, duodenal ulcer)
* Helicobacter pylori positive

Exclusion Criteria:

* Major comorbidities
* Pregnancy
* History of Helicobacter pylori eradication
* History of gastric surgery or other cancers, except to endoscopic treatment due to gastric lesion
The Use of Subcutaneous Implantable Cardiac Defibrillators (ICDs) Following Extraction of Conventional ICDs

Implantable cardiac defibrillators (ICDs) are devices that are put into patients at high risk of sudden cardiac death. They are used to treat life threatening heart rhythm disorders. They have conventionally consisted of a generator sitting under the skin of the chest and leads which pass from veins in the collar bone region to the heart. Problems with these devices can necessitate extraction, with the commonest reason being infection. If extraction is required for infection then re-implantation is usually deferred for approximately one week whilst antibiotics are given so that the risk of infection of the new device can be minimised. This has considerable implications for healthcare resources. A new ICD has been developed that is entirely subcutaneous with no intravenous element. It is already in clinical use and is positioned remote from conventional ICD sites. With no intravenous element there is very little risk of infection in the blood affecting the new device. It is therefore likely to be possible to re-implant these devices immediately after extracting a conventional system. The aim of this research is to assess the outcome in patients re-implanted with this device immediately after conventional ICD system extraction. This data will be compared compared to those who have conventional systems re-implanted after the necessary delay.


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfilling conventional criteria for ICD extraction and who require implantation of a further ICD without a need for pacing.

Exclusion Criteria:

* Indication for anti-bradycardia pacing or cardiac resynchronisation therapy
* Life expectancy \< 1 year
* Need for intravenous inotropes
* Pregnancy
Roll Over Study From 1199.30 BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF)

The aim of this trial is to offer continuation of BIBF 1120 treatment for patients with Idiopathic Pulmonary Fibrosis (IPF) who have completed a prior clinical trial with that drug.

The primary objective will be to establish the long term tolerability and safety profile of BIBF 1120 in Idiopathic Pulmonary Fibrosis (IPF).

As a secondary objective the effects of long term treatment with BIBF 1120 on survival as well as safety and efficacy parameters will be investigated in an open-label, not randomized, un-controlled design.


Eligibility Criteria:
Inclusion criteria:

1. Patient with a primary diagnosis of IPF (according to the 2000 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria, who are willing to continue trial medication.
2. Written informed consent signed prior to entry into the study, in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local law
3. Completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)

Exclusion criteria:

1. Any disease that may put the patient at risk when participating in this trial. Reconsider carefully all exclusion criteria of trial 1199.30. However, patients may qualify for participation even though exclusion criteria may have been met during the course of participation in 1199.30, if the investigator's benefit-risk assessment remains favourable.
2. Participation in another experimental clinical trial (except 1199.30) in the last 8 weeks.
3. Women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to inclusion and at least 10 weeks after end of active therapy.

   Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some Intra Uterine Devices (IUDs), sexual abstinence or vasectomized partner. Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
4. Sexually active males not committing to using condoms during the course of the study and at least 10 weeks after the end of active therapy (except if their partner is not of childbearing potential).
5. Patients who require full-dose anticoagulation (e.g. vitamin K antagonists, heparin, hirudin etc).
6. Patients who require full-dose antiplatelet (e.g. acetyl salicylic acid, clopidogrel etc) therapy.
7. Known or suspected active alcohol or drug abuse.
8. Patient not compliant in previous trial, with trial medication or trial visits.
Effect on Blood Chemistry and Inflammatory Marker of Omega-3 Enriched Total Parenteral Nutrition

Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil emulsions have not been commercially available until very recently. The Objective of this study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total parenteral nutrition in healthy Korean male subjects. This study is designed as a randomized, open-label, 2-treatment, 2-way crossover trial. Blood samples will be collected every 1 hour from 0 to 12 hours after starting an intravenous infusion for triglyceride, glucose, and insulin.

Fish oil is a rich source of omega-3 fatty acids, especially eicosapentanoic acid and docosahexaenoic acid, and it is not used widely in parenteral nutrition because fish oil emulsions have not been commercially available until very recently. The Objective of this study is to to evaluate the effect on blood lipid profiles of omega-3 enriched total parenteral nutrition in healthy Korean male subjects.

This study is designed as a randomized, open-label, 2-treatment, 2-way crossover trial. The 16 subjects will be randomly assigned to 1 of 2 sequences of the two treatments: Combiflex® lipid peri or Winuf® peri will be infused via peripheral venous catheter for 6 hours at 3 ml/kg/h. Blood samples will be collected every 1 hour from 0 to 12 hours after starting an intravenous infusion for triglyceride, glucose, and insulin. Cholesterol, HDL-cholesterol, LDL-cholesterol, AST, ALT, and total bilirubin as liver function biomarkers, and hsCRP as inflammatory biomarker will be analysed at 0, 6 and 12 hour after starting an intravenous infusion.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 30 and 55 years
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg
* An informed consent document signed and dated by the subject
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
* Screening sitting blood pressure \>150 mm Hg (systolic) or \>90 mm Hg (diastolic)
* Use of tobacco in excess of the equivalent of 20 cigarettes per day
* Use of prescription or nonprescription drugs within 10 days
* Blood donation within 2 months prior to dosing, or plasma donation within 1 month prior to dosing
* Severe hyperlipidemic patients
* Severe liver failure patients
A Pilot Trial of Remotely-Supervised Transcranial Direct Current Stimulation (RS-tDCS) to Enhance Motor Learning in Progressive Multiple Sclerosis (MS)

This is a randomized, double-blind pilot clinical trial to test a novel treatment approach to rehabilitate fine motor function in individuals living with progressive multiple sclerosis (MS) using anodal transcranial direct current stimulation (tDCS) to augment manual dexterity training. Treatment will be delivered to individuals at home using a state-of-the-art remotely supervised tele-rehabilitation protocol, a major advantage for patients with respect to ease of access, feasibility, reinforcement learning and minimal burden of in clinic study visit participation. Improvements in fine motor skill will be assessed at each remote session using a novel portable grip device that measures execution and adaptation or learning of fingertip forces during grasp, which is more sensitive than standard measures of hand function.


Eligibility Criteria:
Inclusion Criteria:

* Definite MS diagnosis, progressive subtype
* 9HPT score between -1.0 and -4.0 standard deviations from age-based normative data
* Score of \< 7.5 or less on the EDSS (with caregiver proxy required for those with scores of 6.5 or greater)\*
* Ability to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria:

* Primary neurologic, psychiatric or other medical disorder other than MS
* Use of upper extremity Botox injection within 3 months
* Current use of intrathecal Baclofen
* History of seizure disorder
* History of head trauma or medical device in head or neck
* Clinically significant abnormality on EKG
* Symbol Digit Modalities Test or SDMT score ≥3.0 SD from published norms
* WRAT-4 reading level below average (\<85) (estimated general intellectual function)
* Skin disorder/sensitive near stimulation locations