cyrilzakka/clinical-trials huggingface dataset:
Endometrial Assessment of Women With Uterine Infection

Unexplained infertility is clinically diagnosed when there are no apparent or clear factors causing infertility on regular infertility assessment tools . Failure of implantation is a possible factor causing unexplained infertility .

Implantation is the main rate limiting step in IVF outcome. Implantation is described at the cellular and the molecular levels by adhesion or fixation of a good quality embryo to receptive endometrium within a critical period of time, which is called the window of implantation

Eligibility Criteria:
Inclusion Criteria:

* Women with infertility age from 20-40 years

Exclusion Criteria:

* Any factor of infertility
Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China

This is a Phase 2, open-label, multi-center study of BGB-290 administered orally (PO) twice daily (BID) in adult Chinese patients with advanced HER2(-) breast cancer harboring germline BRCA mutation, which have progressed despite standard therapy, or for which no standard therapy exists.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation
2. Locally advanced or metastatic breast cancer despite standard therapy and the following:

   1. Histologically or cytologically confirmed HER2(-) breast cancer (TNBC or estrogen receptor-positive and/or PR+)
   2. ≤ 2 prior lines of chemotherapy in advanced or metastatic setting
   3. Prior platinum therapy allowed as long as no disease progression while on treatment, or if given in neoadjuvant/adjuvant setting with ≥ 6 months from last platinum to relapse
   4. Prior therapy with an anthracycline and/or a taxane in neoadjuvant/adjuvant or metastatic setting
   5. Archival tumor tissues will be collected from all patients, if available
   6. For HR(+)/HER2(-) breast cancer only: patients must have received and progressed on at least one endocrine therapy either in adjuvant or metastatic setting, or have disease that the treating physician believes to be inappropriate for endocrine therapy
3. Measurable disease as defined per RECIST, version 1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
5. Adequate hematologic and organ function

Exclusion Criteria:

1. Unresolved acute effects of prior therapy of ≥ Grade 2
2. Prior treatment with a poly\[ADP-ribose\] polymerase (PARP) inhibitor
3. Chemotherapy, radiotherapy, biologic therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤ 5 half lives, if applicable, whichever is shorter) prior to Day 1 of Cycle 1
4. Major surgical procedure, open biopsy, or significant traumatic injury ≤ 14 days prior to Day 1 of Cycle 1, or anticipation of need for major surgical procedure during the course of the study
5. Diagnosis of myelodysplastic syndrome (MDS)
6. Other diagnosis of malignancy
7. Untreated and/or active brain metastases.
8. Active infection requiring systemic treatment, active viral hepatitis, or active tuberculosis
9. Clinically significant cardiovascular disease
10. Pregnancy or nursing
11. Known history of intolerance to the excipients of the BGB-290 capsule
A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis

The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have genotype 1 Chronic Hepatitis C
* Subjects must have compensated cirrhosis
* Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
* Subjects with hemophilia may be permitted to enroll with permission of the medical monitor

Exclusion Criteria:

* Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
* Any contraindication to Peg-IFN or RBV therapy
* Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
* A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines
A Phase 2 Study to Evaluate DNTH103 in Adults with Generalized Myasthenia Gravis (MAGIC)

The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).

The study includes the following periods:

* Screening (up to 10 weeks)
* Randomized, blinded, controlled treatment (RCT) period (13 weeks)
* Open-label extension (OLE) period (optional) for eligible participants (52 weeks)
* Safety follow-up (40 weeks)

Eligibility Criteria:
Inclusion Criteria:

1. Must have given written informed consent before any study-related activities are carried out.
2. Adult males and females, 18 to 75 years of age (inclusive) at Screening.
3. Weight range between 40-120 kg at Screening.
4. Diagnosis of gMG by the following tests:

   Acetylcholine receptor antibody (AChR Ab) positive, and

   One of the following:

   i. History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors.
5. Myasthenia Gravis Foundation of America (MGFA) Class II-Iva
6. Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or more
7. Vaccination against N. meningitidis with the quadrivalent meningococcal vaccine, and where available, meningococcal serotype B vaccine within 3 years prior to, or at the time of, initiating study drug.
8. Female participants must:

   Be of non-childbearing potential, or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.
9. Male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm

Exclusion Criteria:

1. History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant
2. Prior history (at any time) of N. meningitidis infection.
3. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during Screening.
4. Any thymic surgery/biopsy within 1 year of Screening.
5. Any known or untreated thymoma.
6. Any history of thymic carcinoma or thymic malignancy.
7. Concurrent or previous use of the following medication within the time periods specified below.

   1. Rituximab within 6 months (180 days) prior to randomization (Day 1);
   2. Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1).
8. Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent.
A Novel Treatment for Metastatic Melanoma

A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream.

A novel treatment for metastatic melanoma combining a laser and an immune-system stimulating cream with or without injection of a substance that makes the tumor more sensitive to the laser.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older
2. Subjects must have Stage III or IV melanoma with histologically confirmed cutaneous metastatic malignant melanoma from any tumor site.
3. Subjects must have measurable disease. See section 10.2 for the evaluation of measurable disease (RECIST).
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Required laboratory parameters (all blood tests must be obtained within 14 days prior to the start of the study treatment):

Platelet count \> 40,000 per mm3 Absolute Neutrophil Count (ANC) \> 1,500 per mm3

Exclusion Criteria:

1. Life expectancy, in the opinion of the investigator of less than 4 months
2. Known allergy to any drugs used in treatment
3. Immunosuppression, including HIV positive subjects, use of systemic steroids daily or other immunosuppressive medications within 1 month of treatment
4. Chemotherapy/immunotherapy within 4 weeks of initiation
5. Local chemotherapy or immunotherapy to target lesions with 4 weeks of initiation
6. Radiation therapy at the treatment site within 4 weeks of initiation
7. Uncontrolled brain metastases
8. History of cutaneous photosensitization or photodermatoses
9. Non-treated, active cancers other than melanoma and non-melanoma skin cancers.
10. Active infectious disease requiring antibiotic therapy
11. Unstable medical illness
12. Past or present major psychiatric illness
13. Pregnant or lactating women
14. End stage renal disease or serum creatinine greater than the upper limit of normal or creatinine clearance \<50cc/min
15. Acute hepatitis (any cause)
6 Minute Propulsion Test Sensitivity to Increased Aerobic Capacity

The goals of this project are to 1)determine the responsiveness of the 6 Minute Push Test (6MPT) and 2) explore the relationship between 6MPT distance and measures of handicap, wheelchair satisfaction, depression, and self-reported avoidance of environmental features.

The 6 minute walk test is a widely used assessment of aerobic capacity, function, and functional change in the ambulatory population. A similar clinical and research outcome instrument that is responsive to changes in aerobic capacity and function are lacking for persons with spinal cord injury (SCI). A 6 minute push test, adapted from the 6 minute walk test may fill the void. The primary aim of this project is to assess if distance traveled in 6 minutes of wheelchair propulsion changes after an increase in aerobic capacity. We hypothesize that participants will push farther in 6 minutes after their aerobic capacity increases. The secondary aim is to explore the correlation between 6MPT distance and handicap, depression, wheelchair satisfaction, and self-reported avoidance of environmental features. We hypothesize increasing 6MPTdistance will be correlated with decreasing depression, decreasing handicap, decreasing self-reported avoidance of environmental features, and increasing wheelchair satisfaction. This is a low risk, high benefit study.

Eligibility Criteria:
Inclusion Criteria:

* T1 or lower injury
* at least 1 year post-injury
* able to self-propel a manual wheelchair
* enrolled in TMP-MN-006

Exclusion Criteria:

* Not enrolled in the IRB approval parent study, "Exercise Treatment of Obesity-Related Secondary Conditions in Adults with Paraplegia", TMP-MN-006
* Unstable angina or myocardial infarction within the past month
* Resting heart rate \>120
* Systolic blood pressure \> 180 mm Hg
* Diastolic blood pressure \> 100 mm Hg
Phase II Dose-Finding Study of SK-0403 With Type 2 Diabetes Mellitus

The purpose of this study is to evaluate the clinical efficacy and safety of SK-0403 in patients with Type2 Diabetes Mellitus


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive subjects diagnosed with type 2 diabetes mellitus
* Stable diet program for at least 8 weeks
* Criteria for HbA1c are met

Exclusion Criteria:

* Type 1 diabetes
* Patients treated with other antidiabetic drugs or Insulin
Evaluation of Functionality of Amputees According to the Medicare Functional K Classification System

The aim of our study is; To evaluate the functionality of lower extremity unilateral amputees, to ensure that the results of the Medicare Functional K Classification System, which provides subjective data for the evaluator, become an objective evaluation method and to determine the functional levels of unilateral amputees; To create an objective data set by applying one-leg standing test, ten meter walking test, L test, figure-8 walking test, joint range of motion, amputee mobility estimator scale, houghton scale and joint position sense evaluation tests.

The study will be carried out at Medicom Orthosis Prosthesis Center and Ortoport Prosthesis Application Center. The study will be conducted in accordance with the principles of human experimentation as defined in the Declaration of Helsinki. For this purpose, amputees who will participate in the study will be given detailed information about the study and will have to sign an informed consent form. 20 unilateral lower extremity amputations will be taken. The inclusion and exclusion criteria of the study are as follows; Inclusion criteria;

Unilateral lower extremity amputation, Using a prosthesis, Being literate, Being between the ages of 18-65, Having a healthy stump, Using your current prosthesis in daily living activities,

Exclusion criteria; Bilateral lower extremity amputation, Unilateral or bilateral amputation of the upper extremity, Having a cognitive or mental problem, Having serious hearing and vision problems, The individual has an orthopedic disease other than amputation, Having an uncontrolled neurological and systemic systemic disease,

SPPS 25.0 (Statistical Package for the Social Sciences) statistical package program will be used to evaluate the data. When the differences between two groups are desired to be evaluated, "Student's t Test" is used if it meets the parametric test prerequisites; If not, the "Mann Whitney-U test" will be used.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral lower extremity amputation,
* Being using a prosthesis,
* Being literate,
* Being between the ages of 18-65,
* Having a healthy stump,
* Using your current prosthesis in daily living activities,

Exclusion Criteria:

* Bilateral lower extremity amputation
* Unilateral or bilateral amputation of the upper extremity,
* Having a cognitive or mental problem,
* Having serious hearing and vision problems,
* The individual has an orthopedic disease other than amputation,
* Having an uncontrolled neurological and systemic systemic disease,
A Study of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Ciltacabtagene Autoleucel Versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) Followed by Autologous Stem Cell Transplant (ASCT) in Participants With Newly Diagnosed Multiple Myeloma

The purpose of this study is to compare the efficacy of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Ciltacabtagene Autoleucel versus Daratumumab, Bortezomib, Lenalidomide and Dexamethasone (DVRd) followed by Autologous Stem Cell Transplant (ASCT) in newly diagnosed multiple myeloma patients.

Multiple myeloma (MM) is a malignant plasma cell disorder characterized by the production of monoclonal immunoglobulin (Ig) proteins or protein fragments (M proteins) that have lost their function.

JNJ-68284528 (ciltacabtagene autoleucel \[cilta-cel\]) is an autologous chimeric antigen receptor T cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA) that is being evaluated to treat participants with multiple myeloma. The primary hypothesis is that in transplant-eligible participants with newly diagnosed multiple myeloma (NDMM), cilta-cel will significantly improve progression-free survival (PFS) and Sustained MRD-negative CR rate compared with Autologous Stem Cell Transplant (ASCT).

Approximately 750 participants (375 per arm) will be randomly assigned in a 1:1 ratio into 2 arms.

Eligibility Criteria:
Inclusion Criteria:

* Participants with documented NDMM according to IMWG diagnostic criteria, for whom high-dose therapy and ASCT are part of the intended initial treatment plan.
* Measurable disease, as assessed by central laboratory, at screening as defined by any of the following:

  1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein level ≥200 mg/24 hours; or
  2. Light chain MM without measurable disease in serum or urine: serum Ig free-light chain (FLC) ≥10 mg/dL and abnormal serum Ig kappa lambda FLC ratio.
* ECOG performance status of grade 0 or 1
* Clinical laboratory values within prespecified range.

Exclusion Criteria:

* Prior treatment with CAR-T therapy directed at any target.
* Any prior BCMA target therapy.
* Any prior therapy for MM or smoldering myeloma other than a short course of corticosteroids
* Received a strong cytochrome P450 (CYP)3A4 inducer within 5 half-lives prior to randomization
* Received or plans to receive any live, attenuated vaccine (except for COVID-19 vaccines) within 4 weeks prior to randomization.
* Known active, or prior history of central nervous system (CNS) involvement or clinical signs of meningeal involvement of MM
* Stroke or seizure within 6 months of signing Informed Consent Form (ICF)
Real Clinical Practice Register of AlbUminuRia Detection in Patients With Previously undiAgnosed Chronic Kidney Disease

Real clinical practice register of Albuminuria detection in patients with previously undiagnosed chronic kidney disease

This register was sponsored and organized by the Association "Eurasian Association of Internal Medicine". It is a multicenter non-interventional register of real clinical practice. The database will include patients aged 40 years and older without pre-existing nephrological disease who are available for a dipstick test for albuminuria. The subjects will be identified by screening all patients who meet inclusion/exclusion criteria during routine outpatient and hospital follow-up. The register does not include follow-up (cross-sectional design).

Patients eligible for the register should be enrolled and documented. The procedure for obtaining informed consent for the collection and analysis of the retrospective data must comply with the local legislation. If necessary, patients will be asked to sign an informed consent document.

All study sites will use standardized electronic CRFs. The Electronic Data Capture (EDC) system should be validated in accordance with current standards and legal requirements. The investigators will log into this system using individual usernames and passwords. Data may only be entered and corrected by the investigator or other authorized study site personnel.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 40 and older at the time of data entry;
* A possibility to check for albuminuria using dipsticks and/or analysis for microalbuminuria or albumin-to-creatinine ratio in a single urine sample.

Exclusion Criteria:

* Unwillingness of the patient to participate in the register;
* Diagnosis of CKD made before the screening for the register;
* Diagnosis of diabetes mellitus (DM) type 1 or type 2 made before the screening for the register;
* Pregnancy;
* Long distance running or very strenuous physical activity in the last 24 hours.
The Effect of Painting Therapy in Children

This study was designed to examine the effect of picture supported art therapy on visual perception, hand functions, participation and quality of life of children in healthy children.

It is planned that at least 25 children in each group will participate in the study. For both the control group and the study group, the sample of the study will consist of children between the ages of 6-12 who do not have any known disease/disability and show typical development, who voluntarily agree to participate in our study and sign the consent form. In addition, children in the control group should not have participated in any art course.Sociodemographic information will be asked first in the evaluation of the individuals in the study. Then, which hand of the children is dominant will be determined with Edinburg Hand Preference Questionnaire. Visual perception of the children will be evaluated with the shape-ground subtest of the Ayres Southern California Sensory Integrity Test, hand skills will be evaluated with the 9-hole peg test and the sense of kinesthesia in their fingers will be evaluated with the kinesthesia subtest of the Ayres Southern California Sensory Integrity Test. Children's quality of life will be assessed with the Young Child Quality of Life Questionnaire in accordance with their age. The Child and Adolescent Participation Questionnaire will be given to the parents to question the social participation of the children and the Conners Parent Rating Scale will be given to the parents to evaluate the disruptive behaviour disorders. Initial assessments will be made both in the study group and in the control group.The children in the study group will receive painting and drawing-based art therapy for 4 weeks, 2 days a week for 1 hour. After 4 weeks, all evaluations will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* The sample of the study for both the control group and the study group,
* To be between 6-12 years old,
* not having any known illness/disability
* voluntarily agree to participate in our study
* The children in the control group should not have participated in any art course.

Exclusion Criteria:

* The sample of the study for both the control group and the study group,
* Not to be between 6-12 years old
* having any known illness/disability (such as neurological, mental illness)
* not voluntarily agreeing to participate in our study
* Children in the control group participated in any art course
Development of a Videogame Prototype Targeting Cigarette and Marijuana Smoking, and Tobacco Product Prevention Among Young Adolescents (smokeScreen)

The goal of this sub-study is to learn more about how an educational videogame can feasibly be implemented and disseminated in youth programs.

The specific aims of this sub-study are:

Specific Aim #1: Work with game development team to develop a web-based version of smokeSCREEN.

Specific Aim # 2: Build a pre-post survey into the smokeSCREEN game to anonymously collect survey information on players' perspectives, beliefs, behaviors around smoking.

Specific Aim # 3: Collaborate with youth programs to pilot test the implementation of the new web-based version of smokeSCREEN into youth programs.

Eligibility Criteria:
Inclusion Criteria:

* Include individuals who have smoked a cigarette previously (since we are evaluating the use of tobacco products in this study, we are including individuals who have previously smoked a cigarette)
* Willing to sit at a computer/tablet/smartphone and play a video game for 45-60 minutes and answer questions before and after playing the video game.
* Be enrolled in a youth program that we have a partnership with.

Exclusion Criteria:

* Does not fit the inclusion criteria.