cyrilzakka/clinical-trials huggingface dataset:
Incremental Clomiphene Citrate Doses in Successive Cycles and FSH, LH and Steroid Hormone Levels

This study was planned to assess the initial and endogenous FSH, LH and steroid responses to incremental CC doses in successive ovulation induction cycles to treat anovulation in patients with unexplained infertility.

In the Bagcilar Research and Training Hospital Obstetrics and Gynecology department outpatient clinic for infertility, the basal gonadotropin and androgen levels are routinely measured. In unexplained infertility couples with normal ovarian reserves the first line drug used for ovulation induction is CC. The starting dose is 50mg/day and the treatment is started within the 2nd to the 5th days of the menstrual cycle and continued for 5 days. Starting on the 2nd-3rd day following the last dose of the drug, the follicular growth was monitored with the transvaginal ultrasound and blood levels of hormones including FSH, LH, estradiol, progesterone, androstenedione, testosterone, and dehydroepiandrosterone sulphate were measured every 2-3 days. In this follow-up, if no follicular growth was observed day21 of the cycle, the CC dose was increased to CC 100mg/day (2X1, 50mg). If follicular growth and ovulation is achieved with no concluding conception, the same dose of CC is used in the following 2-3 cycles. When a maximum number of 2 dominant follicles are obtained ovulation is triggered with recombinant human chorionic gonadotropin (rhCG) and timed coit or intrauterine insemination is conducted.

Eligibility Criteria:
Inclusion Criteria:

* 20-35 years of age
* unexplained infertility
* first-line treatment
* Normal or increased ovarian reserve
* lack of ovulatory response to CC 50mg for 5 days

Exclusion Criteria:

* Male factor
* Tubal Factor
* Severe endometriosis
* Previous ovarian surgery
Study Comparing Effectiveness of Intraperitoneal Insulin Administration to Subcutaneous Insulin Administration

The purpose of this study is to evaluate the effectiveness of insulin delivered in the peritoneum (abdomen)by an implantable pump in Type 1 diabetics.

Implantable insulin delivery pumps have been shown to reduce the occurrence of severe hypoglycemia in Type 1 DM subjects, as demonstrated in numerous European studies. Glycemic control is difficult to attain in subjects using exogenous insulin due to the risk of severe hypoglycemia. This study is aimed at comparing the efficacy of intraperitoneal (IP) insulin therapy to intensive subcutaneous insulin therapy over a period of 12 months.

Eligibility Criteria:
* Type 1 diabetes mellitus (American Diabetes Association definition)
* HbA1c greater than or equal to 7.5%
* Intensive insulin treatment for at least 3 months
* Physical and intellectual ability to operate MIP system
* Subject has been under the routine care of the investigator for at least two months prior to enrollment
* Subject has a reliable support person (defined as a person who has daily contact with the subject and knows whom to contact in the event of an emergency).
* Capability and willingness to perform self-monitoring of blood glucose at least four times daily for 9 months of the study and 7 times daily for 3 months of the study
* Physical and intellectual ability to operate the MIP system and to comply with the data reporting requirements of the study.
* Subject is willing to sign the informed consent form (approved by local Institutional Review Board and Medtronic MiniMed)

Exclusion Criteria:

* The subject's insulin usage exceeds 66 units per day.
* Severe complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months
* Reside at or plan to travel to elevations above 8000 feet during the study period (commercial airline travel is acceptable)
* Subject who is pregnant, of childbearing potential or lactating and is neither surgically sterile, using contraceptives (devices, oral or implanted) nor other physician approved contraceptive
* The subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data
* The subject has previously enrolled in or participated in an investigational drug or device study within the preceding 4 weeks
* The subject has any condition that precludes him/her from completing the study requirements
* Has plans for activities which require them to go 25 feet below sea level
Study to Evaluate the Efficacy, Safety and Tolerability of Photodynamic Therapy(PDT) With Chlorin-e6 in Treating Moderate to Severe Acne

This study aims to evaluate the clinical efficacy, safety and tolerability of a photodynamic therapy(PDT) based on a new photosensitizer, Chlorin-e6, in the treatment of moderate to severe acne. The hypothesis is that the therapy has good efficacy, safety and tolerability.

The acne clinical guidelines all recommend PDT as an alternative therapy for moderate to severe acne based on the excellent performance of ALA-PDT in the treatment of acne vulgaris. Photosensitizers including Porphyrin and Chlorin have also proved to play a positive role in reducing the number of skin lesions and microbial load. Researchers have successfully provided basic evidence that Chlorin-e6 induces inflammation inhibition through AP-1, NF-κB, MAPKs and other pathways of propionibacterium acnes and increases collagen expression in HaCaT cells, which undoubtedly further indicates: As a new type of photosensitive material, Chlorin-e6 derivatives have excellent performance in the face of moderate and severe acne with high levels of inflammation and high risk of scar.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is male or non-pregnant female 18 years of age and younger than 50 years of age.
2. Subject has moderate to severe facial acne vulgaris.
3. Subject has provided written informed consent.

Exclusion Criteria:

1. People who are taking photosensitive drugs;
2. Allergic to any component of the photosensitizer;
3. porphyrins or allergies to porphyrins, with a history of photosensitivity;
4. Pregnant or lactating women and those planning to become pregnant within 3 months;
5. Oral or topical antibiotics, retinoids, glucocorticoids, peroxybenzoyl and other drugs within the past 1 month;
6. Have a history of exposure to sunlight in the past 1 month, have received photoelectric treatment in the past 3 months, or have received facial grinding treatment in the past six months;
7. are using vasodilators (such as nitroglycerin, etc.), beta blockers (such as metoprolol, etc.), anticoagulants (such as warfarin, etc.) and other drugs that easily cause facial capillary dilatation;
8. Patients with facial rosacea, atopic dermatitis, hormone-dependent dermatitis and other facial skin-related diseases;
9. Abnormal blood and urine routine, liver and kidney function, diseases of important organs and hematopoietic system that researchers believe are not suitable for clinical trials;
10. Patients participating in other clinical trials at the same time.
A Study to Evaluate the Safety and Effectiveness of FK778 in Liver Transplant Patients

A proof of concept study to evaluate the safety and effectiveness of FK778 in liver transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients at least 18 years of age and not older than 65 years.
* Female patients of child bearing potential must have a negative serum pregnancy test prior to enrollment and must agree to practice effective birth control during the study.
* Male patients must agree to practice effective birth control methods during the study.
* Patient is a recipient of a primary whole cadaveric liver transplant

Exclusion Criteria:

* Patient has previously received or is receiving an organ transplant other than a liver.
* Patient has received an ABO incompatible donor liver.
* Patient or donor is known to be HIV positive.
* Patient has a current malignancy or a history of malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
* Patient is being transplanted for hepatic malignancy with a single nodule greater than 5.0 cm in diameter or 2 or more nodules with at least one \> 3.0 cm.
* Patient has a serum creatinine \>175 µmol/L at baseline. Patient has uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or an active peptic ulcer or any other unstable medical condition that could interfere with the study objectives.
* Patient who is receiving or may require warfarin or fluvastatin during the study.
* Patient is participating in another clinical trial and/or is taking or has been taking an investigational drug in the 28 days prior to transplant
An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia

Five hundred patients with a confirmed clinical diagnosis of Cervical Dystonia (CD)are planned for enrollment into this open label study. These patients will be Type B toxin naive patients with CD. During this study patients will receive repeat injections of MYOBLOC when deemed appropriate by the Investigator. However, it will be recommended that injections occur not more frequently than every 12 weeks. Total duration of exposure to MYOBLOC will be targeted for at least two years, with potential exposure for up to 7 years in patients with earliest enrollment


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* body weight of at least 46 kilograms
* History of Cervical Dystonia of at least one year's duration who in the opinion of the Investigator requires treatment

Exclusion Criteria:

* Inability to give informed consent
* Patient who has been previously treated with botulinum Toxin Type B
* Patient who has received a Botulinum toxin Type A injection in the last 12 weeks.
* History of phenol injections involving the neck or shoulder region in the last 12 months.
* Patients with neck contractures or cervical spine disease
A Multi-Center Investigation of Patient Acceptability of OPTI-FREE RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)

The purpose of this study was to demonstrate that current successful fulltime daily wear soft contact lens wearers using competitive multi-purpose solutions will note improved comfort when using OPTI-FREE RepleniSH®.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must be between 18 and 65 years of age.
2. Must wear daily wear soft contact lenses a minimum of 8 hours per day,7 days a week.
3. Must be wearing a planned replacement soft lens in a 2 week or monthly replacement modality.
4. Must be using either COMPLETE Multi-Purpose Solution (MPS) Easy Rub or ReNu MultiPlus brand solution for at least 30 continuous days prior to enrollment.
5. Must be free of any contact lens-related symptoms with regard to comfort and vision throughout their wearing hours prior to enrollment, with the exception of end-of-day dryness not limiting all day wear.
6. Must have best corrected distance visual acuity, with contact lenses, of 20/30 or better in each eye.
7. Must be willing to maintain pre-enrollment systemic medication regimens during the study.
8. Must be willing to not use any topical medications or rewetting drops during the 30 day clinical trial duration.
9. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Has used any topical medication or rewetting drops for 7 days prior to enrollment.
2. Achieves best visual correction by monovision.
3. Has modified their systemic medications within 30 days prior to enrollment.
4. Has switched brands of cosmetics during the 30 days prior to the study.
5. Has a history of allergy to any study product ingredients.
6. Is unwilling or unable to meet the study visit timeline.
7. Has any active corneal, eyelid or other anterior segment inflammation or infection, which, in the opinion of the Investigator, would adversely affect successful contact lens wear.
8. Other protocol-defined exclusion criteria may apply.
Venous and Cerebral Glucose Microdialysis in Neurocritical Care: Validation & Correlation

This study evaluates the validity of an intravascular continuous glucose monitoring microdialysis probe, and compares the values to routinely inserted cerebral glucose microdialysis to evaluate the hypothesised relationship between intracranial and intravascular glucose levels.

All recruited patients will in any case have probes inserted in theatre for brain tissue glucose monitoring as a part of their standard clinical care. Probes will be allowed to stabilize following insertion as is standard clinical practice. A peripheral venous catheter will be inserted by the study team to allow introduction of the intravascular microdialysis probe. This will be attached to a regular infusion pump set at 3ml/hr and normal saline, to produce the microdialysate. The efflux of microdialysate will be connected to the biosensor, and once passed over the biosensor the subsequent dialysate will be destroyed. A risk assessment will be made on the basis of the patient's coagulation status and concurrent venous thromboembolism prophylaxis, and if necessary, low dose low molecular weight heparin will be included in the saline infusion to ameliorate risk of local thrombosis in the device. This has a local effect only and does not produce systemic anticoagulation.

After a brief period of probe stabilisation, 2 ml of blood will be withdrawn for blood gas analysis (including glucose), and the probe readings will be calibrated against this value. Subsequent calibration will take place 6 hours later, and then at 12 hourly intervals. A maximum total of 30ml of blood will be required for each patient for blood oxygen content analysis. Clinically necessitated blood sampling for blood gases will continue, and these values will be collected post-hoc from our E-hospital clinical records system.

Further data will be collected post-hoc via e-Hospital clinical records system, including: routinely recorded measures of cerebral extracellular fluid glucose concentration, physiological parameters (central venous pressure, mean arterial pressure, intracranial pressure etc), timing and detail of interventions as determined appropriate by routine clinical decision making.

The study will terminate at 72 hours, whereupon the device will be detached and the peripheral venous catheter will be removed.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 16 and over
2. New episode of acquired brain injury, of any form to include haemorrhage, trauma, infarction
3. Their condition necessitates admission to and care on neurocritical care
4. Their condition necessitates intracerebral microdialysis probe insertion
5. Their condition necessitates arterial line insertion/central venous access and regular/venous blood gas sampling.

Exclusion Criteria:

1. Refusal or withdrawal of consultee agreement and any known patient wishes precluding inclusion.
2. Pregnancy.
3. Peripheral venous cannulation clinically contraindicated.
4. Patients already enrolled in three or more other research studies.
Study Evaluating Changes in Total Drug Load and Seizure Frequency Using Vimpat® (Lacosamide) in Combination Therapy

This observational study aims to investigate how VIMPAT® is used as adjunctive therapy in clinical practice and will also evaluate the subsequent change in the drug load of patients after addition of VIMPAT® to their treatment regimen.


Eligibility Criteria:
Inclusion Criteria:

* The patient has not received Vimpat® more than 7 days prior to start of Non-Interventional Study (NIS)
* The patient must have a diagnosis of epilepsy with partial-onset seizures with or without secondary generalization
* Based on the physician's clinical judgment, it is in the patient's best interest to be prescribed adjunctive Vimpat® (ie, the decision to prescribe Vimpat® is made by the physician)
* Patient must be at least 18 years of age
* The patient must have had at least one seizure within the last 3 months prior to enrolment
Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants

Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an inflammatory necrosis of the bowels, to date no study has examined the effect of anti-inflammatory therapy on this dreaded disease once it is diagnosed. The investigators propose a multi-center, randomized, placebo-controlled, double-blinded pilot study to examine the effect of hydrocortisone in infants diagnosed with stages II and III NEC. The investigators will follow C-reactive protein (CRP) levels as a marker of systemic inflammation for the primary outcome in this study.

Given the extensive inflammatory response inherent to NEC, anti-inflammatory treatment may be of benefit, to both reduce inflammation and as a potential therapy to improve outcome. To date, there is no specific therapy for NEC that has been found to improve outcome, but corticosteroids have yet to be investigated in that capacity. Therefore, we propose to examine the effect of hydrocortisone for treatment of NEC in a randomized, blinded, placebo-controlled pilot study, focusing on a primary outcome of C-reactive protein levels at 3 and 7 days of therapy as a measure of inflammation. In addition, we will follow several secondary outcome measures to determine the possibility of improved outcome in those infants assigned to hydrocortisone.

The investigators hypothesize that infants diagnosed with NEC who receive hydrocortisone will have significantly lower C-reactive protein levels at 3 and 7 days of treatment versus infants who receive placebo.

Eligibility Criteria:
Inclusion Criteria:

* Infant born at gestational age less than 34 weeks
* Birth weight less than 2500 grams
* Diagnosis of stage II or III NEC made by attending neonatologist, neonatology fellow, or pediatric hospitalist
* Legally authorized representative is able to provide written informed consent prior to the performance of an protocol-specified evaluations or procedures
* Consent can be obtained and study drug can be administered within 6 hours of diagnosis

Exclusion Criteria:

* congenital gastrointestinal anomaly
* subject is already receiving parenteral steroid therapy or subject has received parenteral steroids within one week prior to study entry
* subject has received indomethacin therapy within 48 hours prior to being diagnosed with NEC
Evaluation of Pharmacokinetics and Safety of AJU-A51 in Healthy Adults

To evaluate the safety and pharmacokinetic characteristics of AJU-A51 in healthy adults

This study is to assess the safety and pharmacokinetic characteristics between co-administration of A51R1 with A51R2 and administration of AJU-A51.

This is an open-label, randomized, single-dose, 2x2 crossover study in healthy male and female subjects to assess the bioequivalence after taking the study drugs.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults over the age of 19 years at the time of screening
2. Individuals who had 18.5 kg/m2 ≤ Body Mass Index(BMI) \< 29.9 kg/m2 and total body weight ≥ 50 kg

   \* BMI = Weight(kg)/ Height(m)2
3. Individuals who were deemed to be appropriate as study subjects screening examination(laboratory tests and ECG etc.)
4. Individuals who agreed proper contraception during the study
5. Individuals who signed an informed consent form and decided to participate in the study after being fully informed of the study prior to participation

Exclusion Criteria:

1. Individuals with a medical evidence or a history of clinically significant hepatobiliary, renal, neurologic, respiratory, digestive, endocrine, blood-oncology, urinary, cardiovascular, musculoskeletal or psychiatric
2. Individuals with an active chronic or acute disease within 1 month.
3. Individuals with a medical history of gastrointestinal disease (e.g., Crohn's disease and ulcer) or gastrectomy (excluding simple appendectomy or herniotomy) that may affect drug absorption
4. Individuals with a severe allergies(except for allergic rhinitis or dermatitis)
5. Individuals with the following medical histories at screening test:

   * T1DM or diabetic ketoacidosis
   * Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption etc.
   * Renal disorder or pancreatitis etc.
6. A history of regular alcohol consumption exceeding 21 units/week within the 3 months(1 unit = 10 g = 12.5 ml) prior to screening or individuals who cannot quit drinking from 48hr prior to the first
7. Individuals who cannot eat standard meal in institution
8. Women who are pregnant or may be pregnant
9. Individuals who were deemed to be inappropriate to participate in the study by the investigator
To Evaluate Safety, Tolerability, Plasma Drug Levels And Other Biological Effects In Healthy Volunteers

The purpose of this study is to evaluate safety and tolerability after a single administration of PF-03382792 in healthy volunteers.; and to evaluate plasma drug levels and biological activity.

Evaluate the safety, tolerability, plasma concentrations of PF-03382792 and other biological activity following a single dose of PF-03382792. Three ascending single doses of PF-03382792 were administered in this study (0.05 mg, 0.15mg and 0.5 mg). The decision to terminate the study was made on June 4, 2010 due to safety findings and limitations regarding the levels of the metabolite projected for doses above 0.5 mg.

Eligibility Criteria:
Inclusion Criteria:

* For all cohorts, healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
* Signs or symptoms of adrenal insufficiency.
* Ocular lens (eye) abnormalities.
LLM-Generated Coaching Prompts

This pilot study aims to evaluate whether personalized coaching prompts generated by a large language model (LLM) can effectively increase physical activity levels among participants. The study will involve 50 participants who will receive daily text messages, either personalized by the LLM or generic, over a 14-day period. Participants will share their HealthKit data for analysis. The findings will inform the development of future versions of the My Heart Counts application, enhancing user engagement and health outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age: Participants must be 18 years or older.
* Health Status: Participants must be healthy enough to engage in physical activity.
* Language Proficiency: Participants must be able to read, understand, and consent in English or Spanish (dependent on which is being studied).
* Device Ownership: Participants must possess an iPhone and an Apple Watch.
* Data Sharing: Participants must be willing to share their HealthKit data via secure upload.

Exclusion Criteria:

* Age: Participants under the age of 18.
* Health Status: Participants who are not healthy enough to engage in physical activity.
* Language Proficiency: Participants who cannot read, understand, or consent in English or Spanish.
* Device Ownership: Participants who do not have both an iPhone and an Apple Watch.
* Data Sharing: Participants unwilling to share their HealthKit data via secure upload.