cyrilzakka/clinical-trials huggingface dataset:
A Study of PRN1008 in Patients With Pemphigus

This was a Phase 3 randomized, parallel-group, double-blind, placebo-controlled trial (blinded treatment \[BT\] period) followed by an open-label extension \[OLE\] period intended to evaluate the efficacy and safety of oral PRN1008 in moderate to severe pemphigus. After completing the open-label extension period, eligible participants might continue in a long term extension (LTE) Period of 48 weeks.

A total of 131 male or female participants with newly diagnosed or relapsing moderate to severe pemphigus (pemphigus vulgaris \[PV\] or pemphigus foliaceus \[PF\]) were enrolled in the trial worldwide.

The trial would last 68 weeks (approximately 17 months) for each participant. For participants eligible to enroll in the LTE, the trial might last up to 116 weeks.

Participants were randomized at Day 1, using a 1:1 ratio to receive PRN1008 or placebo twice per day, by relapsing/newly diagnosed disease history (newly diagnosed defined as within 6 months of screening).

Eligibility Criteria:
Inclusion Criteria:

* Male or female participants, aged 18 to 80 years old with moderate to severe, newly diagnosed or relapsing PV or PF, with a clinical presentation and histopathology consistent with PV or PF.
* Positive circulating anti-desmoglein 1 (anti-dsg1) or 3 autoantibody titer.
* At screening, pemphigus disease area index score of at least 9 points for relapsing participants or at least 15 points for newly diagnosed participants.
* Adequate hematologic, hepatic, and renal function.
* Effective means of contraception.

Exclusion Criteria:

* Suspected paraneoplastic pemphigus and other forms of pemphigus that were not PV or PF.
* Previous use of a Bruton tyrosine kinase inhibitor.
* Pregnant or lactating women.
* Electrocardiogram clinically significant abnormalities.
* A history of malignancy of any type within 5 years before Day 1, other than surgically excised non-melanoma skin cancers or in situ cervical cancer.
* Use of immunologic response modifiers as concomitant medication and with the washout period.
* Use of proton pump inhibitor drugs such as omeprazole and esomeprazole within 3 days of Day 1.
* Concomitant use of known strong-to-moderate inducers or inhibitors of cytochrome P450 3A (CYP3A) within 3 days or 5 half-lives (whichever is longer) of Day 1
* Use of CYP3A-sensitive substrate drugs.
* Had received any investigational drug within the 30 days before Day 1.
* History of drug abuse within the previous 12 months.
* Alcoholism or excessive alcohol use.
* Any other clinically significant disease, condition or medical history that, in the opinion of the Investigator, would interfere with participant safety, trial evaluations, and/or trial procedures.
Custom Needle Preparation for Suprachoroidal Steroid Injection (One Year Results)

Suprachoroidal drug delivery is a recent route for managing various ocular conditions. Safety and long term results are still under investigations.

In this study, we aim to analyze the long term results of suprachoroidal injection in treating various retinal diseases to focus on its efficacy, safety and long term ocular effects as ocular hypertension, cataract progression and macular edema resolution.

Eligibility Criteria:
Inclusion Criteria:

* cases with central macular thickness more than 250 microns measured by optical coherence tomography due to one of the following conditions:
* Diabetic macular edema
* Vogt-koyanagi Harada disease
* Retinal vein occlusion.

Exclusion Criteria:

* other causes of increased macular thickness as age related macular degeneration and myopic choroidal new vascularization.
* Cases with confirmed diagnosis of glaucoma.
Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose

This is an open-label, Phase I study. Study treatments will entail a four-way crossover among three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics, dose proportionality for subcutaneous doses, and absolute bioavailability versus an intravenous dose.


Eligibility Criteria:
Inclusion Criteria:

1. Subject weight between 60 and 80 kg
2. Subject a non-smoker
3. Subject in good physical health, based on history, physical exam, appropriate laboratory and diagnostics tests at screening with no evidence of clinically significant chronic medical condition.

Exclusion Criteria:

1. Subject with known hypersensitivity to methylnaltrexone, naltrexon or other opioids
2. Subject consuming any prescription medication within the past two weeks, over-the-counter (OTC) products within seven days, any experimental medication within 30 days prior to study screening, or of any drug with a half-life longer then three days within 10 half-lives (\>30 days) of screening
3. Subject consuming barbiturates or other inducers or inhibitors of CYP450 within 3 months of screening
4. Subject with history or evidence of cardiovascular, gastrointestinal, hepatic, neurological, pulmonary, and renal or other significant chronic illness.
Protocol for Postmenopausal Women at Increased Risk of Developing Breast Cancer

A study to examine the potential associations between common single nucleotide polymorphisms and pre-cancerous conditions in breast tissue specimens from postmenopausal women.

A study to examine the correlation between single nucleotide polymorphisms (SNPs) affecting steroid and carcinogen metabolism and benign breast tissue cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer and taking hormone replacement therapy.

Eligibility Criteria:
Inclusion Criteria:

* postmenopausal women on or off hormone replacement therapy
* at high risk of developing breast cancer determined by family or personal history
* postmenopausal women not on hormone replacement therapy for at minimum six months prior to corresponding aspiration
* willing to participate in companion protocol (KUMC HSC#4601) for random periareolar fine needle aspiration (RPFNA) for correlational studies

Exclusion Criteria:

* women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to RPFNA.
Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients

This is a single-center, prospective, non-randomized, observational study to evaluate specific proteogenomic biomarker panels for acute rejection (AR) and chronic allograft nephropathy/interstitial fibrosis and tubular atrophy (CAN/IFTA) in blood, urine and kidney tissue (biopsy) in kidney transplant recipients. Proteogenomic profiles will be routinely monitored over one year after enrollment.

OBJECTIVE: The objective of this phase of the study is to allow the clinical site to gain familiarity with patient recruitment, sample and data collection, and interpretation of the proteogenomic biomarker report provided, through retrospective analysis. This phase of the study will provide a platform for the transplant physicians to gain confidence with the format, logistics, and potential use of the biomarker tests on blood and tissue.

Eligibility Criteria:
Inclusion Criteria: Patients who meet all of the following criteria are eligible for enrollment as study participants:

1. Male and female recipients of all races, ≥18 years of age.
2. Patients undergoing primary or subsequent deceased-donor or living donor kidney transplantation.
3. Subject and/or guardian must be able to provide informed consent.
4. Subject and/or guardian must be able to comply with the study protocol.

Exclusion Criteria:

1. Need for combined organ transplantation with an extra-renal organ and/or islet cell transplant.
2. Recipients of previous non-renal solid organ and/or islet cell transplantation
3. Infection with HIV.
4. Inability or unwillingness of a participant and/or guardian to provide informed consent

   -
Visual Quality of Cataract Patients with High Myopia After Implantation of Different Intraocular Lenses

This prospective study aims to compare the visual outcomes following the implantation of two different types of multifocal intraocular lenses (IOLs) in highly myopic patients. The study will evaluate visual quality, refractive outcomes, and patient satisfaction using various visual assessment techniques and subjective satisfaction surveys.


Eligibility Criteria:
Inclusion Criteria:

* 1: Patients are older than 18 years

  2: The axial length (AL) measured by IOLMaster 700 is ≥26 mm

  3: No anterior or posterior segment pathology that could potentially compromise visual potential (such as glaucoma, myopic traction maculopathy, corneal leukoma, etc.).

  4: Able to understand, cooperate, and complete all follow - ups

Exclusion Criteria:

* 1: History of amblyopia

  2: Retinal detachment in the same eye or the fellow eye

  3: Presence of multiple peripheral retinal degenerative changes

  4: History of previous ocular surgery
A Study to Evaluate Efficacy and Safety Effects Using Mikelan® LA Ophthalmic Solution (OS) 2% Versus Timoptol® XE Ophthalmic Solution (OS) 0.5% in Ocular Hypertension Patients

The primary objective of the clinical study is to evaluate the efficacy and safety for Mikelan LA eye drops 2% (once per day) of intra-ocular pressure decreased.


Eligibility Criteria:
Inclusion Criteria:

1. Male or females outpatients with primary open-angle glaucoma or ocular hypertension;
2. Subjects who have received Latanoprost at least 4 weeks, and in the end of screening period, subject's Intra-Ocular Pressure is ≧18mmHg (choice of one eyes is possible), or Investigator judges the reduction of IOP is insufficient of individual subject.
3. Aged between ≧ 20 and ≦80 years old when giving informed consent to the study.

Exclusion Criteria:

1. Hypersensitivity to either oral or topical beta-blocker therapy or to any ophthalmic solution used in the study;
2. Patients wearing contact lenses;
3. Patients with severe dry eyes;
4. Patients who had ophthalmic surgery including cataract surgery, trabeculotomy or trabeculectomy within three months of study start;
5. Patients who had laser trabeculoplasty within 2 months before starting study;
6. Patients who had corneal contamination, and acute ophthalmic infection, or inflammatory ophthalmic disorder 2 months before starting study;
7. Patients who had herpetic keratitis or corneal ulcer within 2 months before starting study;
8. Patient who are receiving systemic administration of drugs that may have and effect on IOP;
9. Patients who have poorly controlled heart failure, sinus bradycardia, atrioventricular block (1 and 2 grade), or cardiogenic shock;
10. Patients with brochial asthma, bronchospasm or severe chronic obstructive pulmonary disease or a history thereof;
11. Patients with poorly controlled diabetes or diabetic ketoacidosis or metabolic acidosis;
12. Patients with aortic stenosis, Raynaud's syndrome, intermittent claudication, or pheochromocytoma;
13. Patients with myasthenia gravis;
14. Patients with severe hepatic or renal disorder judged by investigator;
15. Patients who have confirmed or potential pregnancy, current lactation, or wish to become pregnant during the study period;
16. Patients who have treatment with any investigational drug when giving informed consent;
17. Patients with significant alcohol, drug or medication abuse as judged by investigator;
18. Patients whom investigator judges as subjects to be inappropriate for the clinical study (e.g., patient with severe complication)
Combining a Smoke Ending Aid With Behavioral Treatment - 1

The purpose of this study is to combine a smoke ending aid with behavioral treatment.

The prime objective of this Innovative Stage I A/B Behavioral Therapy Development Research project is to conduct a pilot study under randomized, double-blind, placebo controlled conditions, to provide preliminary estimation of the efficacy of a 6 week Accu Drop nicotine fading protocol used in conjunction with cigarette tapering to bring about termination of cigarette usage in moderate to heavy smokers (\*15 cpd) who are interested in smoking cessation. Both the experimental and control groups in this study will receive six weeks of the manually driven behavioral treatment by experienced and trained therapists. The experimental group (N=30) will also be prescribed active Accu Drops (AD\&C) while the control condition (N=30) will be prescribed placebo Accu Drops (PD\&C) very similar in appearance, viscosity, and taste to active Accu Drops. Completion of the study protocol and smoking cessation rates at 1 week, 1 month, and 6 months post-treatment will be the prime measures of efficacy. The findings of this study will provide sufficient preliminary indication for the efficacy of the experimental treatment and its extended investigation in a Phase II study or for its nonefficacy.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older, and no greater than 65 years of age
* Medically stable
* Smoke at least 15 filtered cigarettes daily
* Motivated to quit smoking

Exclusion Criteria:

* Medically unstable
* Currently psychiatrically unstable (schizophrenia, unstable psychosis, untreated major depression, active substance abuse within the past 6 months)
* Pregnant
Influence of Immersion in Water During Labor on the Request of Epidural Anesthesia by Pregnant Women

Women are showing a growing interest in less medicalized childbirth. According to the french 2021 perinatal survey, 52.2% of women want to limit medical procedures and 38.2% of women want childbirth without epidural anesthesia. Between 77 and 82% of deliveries nevertheless lead to an epidural anesthesia. The painful feeling seems to be the main motivation for using this mode of anesthesia.

In the scientific literature, few data from clinical studies focus on the effects of immersion in water during childbirth. The analgesic effects of immersion in water to lessen the painful experience are yet to be proven. The opening of a physiological delivery room with a bathtub at the Saint-Etienne University Hospital since October 2020 provides data that has not been exploited yet and could make possible to answer the question of the analgesic effects of immersion in water during labour. The difficulties of analysis and the subjectivity of the painful feeling led us to consider the request of epidural anesthesia as the main analysis criterion.

Eligibility Criteria:
Inclusion Criteria:

* All women who used the physiological delivery room of the Saint-Etienne University Hospital between October 2020 and December 2022.

Exclusion Criteria:

* Absence of physiological desire for childbirth.
* Medical indication for epidural anesthesia.
Combined Kinetic Chain Exercises on Knee Osteoarthritis

study will be conducted at faculty of physical therapy cairo university to investigate the effect of combined kinetic chain exercises on static and dynamic hamstring and quadriceps strength in knee osteoarthritis patients

the study will be conducted at faculty of physical therapy cairo university to investigate the effect of combined kinetic chain exercises on static and dynamic hamstring and quadriceps strength ,knee pain ,function ,H/Q ratio in knee osteoarthritis patients .using lafayette hand held dynamometer to measuring static strength of hamstring and quadriceps ,and free weight by Brzycki formula for measuring dynamic hamstring and quadriceps strength by determining 1 repetition maximum ,and pain measured by visual analogue scale (VAS) rating from (0 = no pain ) to (10= worst pain ) ,and function by Western Ontario and McMaster Universities Osteoarthritis Index questionnaire lower score indicate patient get better ,number of patients will be 34 divided into 2 groups ,each group will include 17 patient ,with 2 drop out according to sample size calculation ,each group will receive conventional tens for 20 min. and hot back for 15 min. and stretching exercises for hamstring,quadriceps,calf muscles ,while the experimental group will be increased by combined kinetic chain exercises

Eligibility Criteria:
Inclusion Criteria:

* the patients age from38 to 65
* recent radiographs confirming grade 2 and 3 (mild to moderate ) osteoarthritis
* primary and secondary Osteoarthritis
* both gender
* unilateral knee osteoarthritis
* pain in the knee for most days of prior month
* morning stiffness less than 30 min. in duration
* patient body mass index (BMI) between 18.5 and 29.9 kg/m2

Exclusion Criteria:

* neurological disorders
* wheelchair bound
* significant cognitive impairment
* present systemic inflammatory arthritis
* history of hip and knee arthroplasty

  * history of trauma or surgical arthroscopy of either knee in the last 6 months
* received knee intra-articular injection within the last 3 months
* under anticoagulant therapy ,recent or imminent surgery (within 3 months)
A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users

The main purpose of this study is to simulate if oxycodone and naltrexone combination capsules (ALO-02) were to be tampered with by dissolving and then injecting intravenously for the purpose of getting high.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Non-dependent, recreational opioid users
* Must include at least one of these routes of administration: intranasal use on at least 3 occassions in the past year or intravenous use on at least 1 occasion in the past year before Screening (Visit 1).

Exclusion Criteria:

* Diagnosis of substance and/or alcohol dependence
* Subject has participated in, is currently participating in, or seeking treatment for substance and/or alcohol related disorder
* History of sleep apnea.
Paracor Ventricular Support System (PVSS) for Patients With Heart Failure

This is a limited safety and feasibility study to evaluate the PVSS Introducer and Paracor Ventricular Support System when used to treat patients with heart failure. The implant, which is loaded onto the delivery system, is placed over the epicardial surface of the right and left ventricles.

No formal hypothesis testing will be performed; descriptive statistics will be used to summarize patient outcomes. The results of the study will be used to guide the design and sample size estimation of future studies.

Please refer to brief summary.

Eligibility Criteria:
Inclusion Criteria:

* NYHA functional class II or III
* Best medical therapy
* Ejection fraction \<= 35%

Exclusion Criteria:

* Heart measurements too large or small for implant sizes
* Intra-cardiac thrombus
* Restrictive cardiomyopathy
* Not a candidate for sternotomy
* Expected adhesions
* Previous coronary artery bypass graft (CABG)
* Active infection
* Stroke, surgery, or implantable cardioverter defibrillator (ICD) within 3 months
* Myocardial infarction (MI) within 1 month
Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome

Purpose: To determine the effects of activity management training on pain, occupational performance, quality of life, depression, anxiety and occupational balance in women with fibromyalgia syndrome (FMS).

In addition to, reducing pain, which is the main symptom of FMS, by regulating the activity-rest cycle, it is aimed to increase people's participation in daily life and improve their quality of life.

Method: A randomized controlled trial. A total of 10 sessions of individual-internet-based activity management training are applied to women with FMS in the intervention group, 2 sessions a week for 5 weeks, 1st and 10th sessions are pre- and post-training evaluation. Assessments before and after training The Revised Fibromyalgia Impact Questionnaire (FIQR), Canadian Occupational Performance Measure(COPM), Pain-activity patterns scale (Pomp/APPS) ,Nottingham Health Profile,The hospital anxiety and depression scale,The Occupational Balance Questionnaire (OBQ) is applied.Although no intervention is applied to the control group, only preliminary and final evaluations are completed.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with FMS by a specialist physician,
* Being a woman between the ages of 18-64,
* To be literate,
* Having and actively using a smartphone or a computer

Exclusion Criteria:

* Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders,
* Have previous activity management training,
* Currently and up to 4 weeks on psychotropic medication,
* Breastfeeding and pregnancy
A First-in-Human Study Using BDC-4182 as a Single Agent in Advanced Gastric and Gastroesophageal Cancer

A first-in-human study using BDC-4182 as a single agent in gastric and gastroesophageal cancers

This is a dose escalation study designed to evaluate the safety and tolerability of BDC-4182 to establish the recommended Phase 2 dose (RP2D). Participants will be enrolled in each dose cohort until the maximum tolerated dose (MTD) is reached. Additional participants may be enrolled into backfill cohorts at dose levels that have been cleared to collect additional safety and tolerability data. Additional participants may be enrolled at the determined RP2D in an expansion portion of the study.

Eligibility Criteria:
Key Inclusion Criteria:

* Has disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.
* Subjects must have histologically/cytologically confirmed gastric or gastroesophageal cancer that is metastatic (Stage 4) or unresectable (Stage 3).
* Subjects must have received at least 1-2 prior lines of locally available standard therapies or must be intolerant of standard therapies.
* For subjects in escalation: If prior Claudin 18 IHC expression is known, the subject must have some degree of Claudin 18 expression as defined as Positive or have expression ≥ 1% of tumor cells IHC ≥ 2+. Consult with Medical Monitor as needed.
* Adequate organ function
* Agree to have a biopsy prior to enrollment, at acceptable risk in the judgement of the Investigator. If a biopsy is not safely accessible or clinically feasible, an adequate archival tumor sample must be submitted.

Key Exclusion Criteria:

* Known central nervous system (CNS) metastases except for disease that is asymptomatic, clinically stable, and has not required steroids for at least 14 days before starting study treatment.
* Cardiac disease, pulmonary disease, or hepatic disease
* Active infection
* History of inflammatory eye disease
* Residual toxicity from a previous treatment
* Any investigational agent or standard anti-cancer therapies within 28 days before starting study treatment or within 5 estimated elimination half-lives, whichever is shorter.
Open Label Arimidex in Gynecomastia

The purpose of this study is to evaluate the safety, effectiveness, pharmacokinetics and pharmacodynamics of anastrozole (ARIMIDEX™) in the treatment of boys with gynecomastia.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent/assent (as per local requirements), males aged 11-18 yrs. (after his 10th and prior to 19th birthday), gynecomastia, one breast measuring ≥ 2 cm in diameter (by ultrasound or caliper measurement) that has not decreased during the prior 3 month period by medical history and has been present for 12 months or less (date of onset based on best estimate of treating physician after discussion with patient and or patient's parent/guardian), normal renal liver and thyroid function, no evidence of hormone producing tumor, no evidence of hypogonadism or androgen resistance.

Exclusion Criteria:

* Patients who have been given medications known to cause gynecomastia within the previous 6 months, involvement in the planning and conduct of the study (includes AZ staff and investigative site staff), previous enrollment in the present study, investigators opinion patient would be unable to comply with study protocol.