cyrilzakka/clinical-trials huggingface dataset:
Phase Ib/II Study of SHR-8068 Injection in the Treatment of Advanced Non-small Cell Lung Cancer

To evaluate the tolerability and safety of SHR-8068 in combination with adebrelimab in subjects with advanced NSCLC To evaluate the efficacy of SHR-8068 in combination with adebrelimab and platinum-based chemotherapy in subjects with advanced NSCLC


Eligibility Criteria:
Inclusion Criteria:

1. Age 18\~75 years old, both male and female
2. Stage 1: pathologically diagnosed, incurable NSCLC subjects who have failed standard treatment
3. Stage 2: have a histologically or cytologically confirmed diagnosis of relapsed or metastatic NSCLC; have not received prior systemic treatment for their recurrent or metastatic NSCLC; PD-L1 TPS \<50% as confirmed by central laboratory
4. At least one measurable lesion based on RECIST v1.1 criteria
5. ECOG PS score: 0-1 points
6. Expected survival period ≥ 3 months
7. Good levels of organ function
8. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

1. Patients with EGFR activating mutation, positive ALK fusion gene or known ROS1 fusion gene
2. Untreated brain metastases; or associated with meningeal metastases, spinal cord compression, etc.
3. Uncontrolled pleural, pericardial, or ascites with clinical symptoms
4. Severe bone damage caused by tumor bone metastasis
5. Suffering from other malignant tumors in the past 3 years or at the same time
6. Presence of any active or known autoimmune disease
7. Systemic treatment with corticosteroids or other immunosuppressants within 2 weeks before the first dose
8. Have clinical symptoms or diseases of the heart that are not well controlled
9. Serious infection occurred within 1 month before the first dose
10. Past or current active interstitial lung disease requiring treatment, non-infectious pneumonia requiring glucocorticoid system treatment; current active pneumonia or pulmonary function test confirmed severe impairment of pulmonary function
11. With active pulmonary tuberculosis
12. Known positive history of human immunodeficiency virus test or acquired immunodeficiency syndrome, known active viral hepatitis
13. Known history of inflammatory bowel disease
14. Inoculated with live attenuated vaccine within 28 days before the first dose
15. Known allergic reaction to other monoclonal antibodies
16. Received \>30 Gy of pulmonary radiotherapy within 6 months before the first dose; received major surgical treatment, systemic chemotherapy, immunotherapy or other clinical trial drugs within 4 weeks before the first dose; within 2 weeks before the first dose Received palliative radiotherapy; oral molecularly targeted drugs, discontinued to less than 5 half-lives before first dose; failure to recover from toxicity and/or complications of previous interventions to NCI-CTC AE ≤1 degree
17. According to the judgment of the researcher, there are other factors that may affect the results of the study or cause the study to be terminated halfway.
Regorafenib in Subjects With Metastatic Colorectal Cancer (CRC) Who Have Progressed After Standard Therapy

This is a phase III B, prospective, interventional, open-label, single-arm, multicenter study to provide regorafenib to subjects diagnosed with metastatic colorectal cancer who have failed after standard therapy and for whom no therapy alternatives exist, in the time between positive results and approval / availability on the market, and to collect safety data for regorafenib until market access.

Regorafenib is an oral (i.e. taken by mouth) multi-targeted kinase inhibitor. A kinase inhibitor targets certain key proteins that are essential for the survival of the cancer cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The growth of the tumor may be decreased by preventing these specific proteins from functioning.

The primary endpoint of this study will be safety.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18 years of age
* Life expectancy of at least 3 months
* Histological or cytological documentation of adenocarcinoma of the colon or rectum. All other histological types are excluded.
* Subjects with metastatic colorectal cancer (Stage IV)
* Progression during or within 3 months following the last administration of approved standard therapies which must include fluoropyrimidine, oxaliplatin, irinotecan, bevacizumab and cetuximab/panitumumab (if KRAS WT) (WT: wild type)
* ECOG Performance Status of ≤ 1 (ECOG: Eastern Cooperative Oncology Group)
* Adequate bone marrow, liver and renal function
* Women of childbearing potential and men must agree to use adequate contraception

Exclusion Criteria:

* Prior treatment with regorafenib
* Congestive heart failure \>/= New York Heart Association (NYHA) class 2
* Uncontrolled hypertension (Systolic blood pressure \> 140 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management)
* Any hemorrhage or bleeding event \>/= CTCAE Grade 3 within 4 weeks prior to the start of study medication.
* Persistent proteinuria of CTCAE Grade 3 (\>3.5g/24 hours)
* Unresolved toxicity higher than CTCAE (v. 4.0) Grade 1 attributed to any prior therapy/procedure excluding alopecia, hypothyroidism and oxaliplatin induced neurotoxicity \</= Grade 2
* Systemic anticancer therapy including cytotoxic therapy, signal transduction inhibitors, immunotherapy, and hormonal therapy during this trial or within 4 weeks (or within 6 weeks for mitomycin C) before starting to receive study medication
Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases

Evaluating the safety and effectiveness of a CD25 monoclonal antibody-based prophylactic acute graft-versus-host-disease (aGVHD) regimen following unrelated umbilical cord blood transplantation (UCBT) for malignant hematologic disorders in reducing severe aGVHD.

Acute graft-versus-host disease (aGVHD) is a major complication and leading cause of non-relapse mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Preliminary research findings suggest that the addition of CD25 monoclonal antibody at +3 days post unrelated umbilical cord blood transplantation (UCBT) has reduced the incidence of grade III-IV aGVHD compared to previous protocols. In order to further explore how to improve prevention strategies of aGVHD and reduce the incidence of severe aGVHD, we performed this study to evaluate the safety and effectiveness of a prophylactic GVHD regimen utilizing CD25 monoclonal antibody post-UCBT for malignant hematologic disorders, aimed at reducing the incidence of severe aGVHD.

Eligibility Criteria:
Inclusion Criteria:

* Malignant hematologic disorders;
* Patients undergoing UCBT;
* Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during treatment and for the following year.

Exclusion Criteria:

* Non-malignant hematologic disorders;
* History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
* Uncontrolled bacterial, viral, or fungal infections. "Uncontrolled" is defined as lack of clinical improvement or progression despite adequate antimicrobial therapy;
* HIV infection or active hepatitis B or C virus infection;
* Pregnant or lactating women;
* Substance abusers; subjects with uncontrolled psychiatric disorders; individuals with cognitive dysfunction;
* Participation in similar clinical studies within the past 3 months;
* Subjects deemed unsuitable by the investigator (e.g., those expected to be unable to adhere to treatment due to financial constraints).
Magnetic Resonance Imaging In Acute ST-Elevation Myocardial Infarction

Cardiovascular magnetic resonance imaging enables comprehensive assessment of cardiovascular function, morphology and pathology. The investigators aim to evaluate the nature and clinical significance of magnetic resonance imaging parameters in patients presenting with first acute ST-elevation myocardial infarction.


Eligibility Criteria:
Inclusion criteria:

* First ST-elevation myocardial infarction according to the European Society of Cardiology/American College of Cardiology committee criteria
* Primary percutaneous coronary intervention within 24 hours after symptom onset

Exclusion criteria:

* Age \< 18 years
* Any history of a previous myocardial infarction or coronary intervention
* Clinically unstable patients (Killip class \>2)
* Renal failure (estimated glomerular filtration rate \< 30 ml/min/1.73 m2)
* Contraindications to cardiac magnetic resonance imaging (pacemaker, cerebral aneurysm clip, orbital foreign body, known or suggested contrast allergy to gadolinium, claustrophobia)
* Inability to provide informed consent
Drug-Drug Interaction of DWP16001 in Combination With DWC202204 and DWC202205 in Healthy Male Adults

The purpose of this study is to evaluate drug-drug interaction by comparing the pharmacokinetics (PK)/pharmacodynamics (PD), safety, and tolerability of single/multiple doses of DWP16001 , DWC202204 and DWC202205 alone or in combination in healthy male adults.

\* Open label, multiple dose, 2 part, two period, single sequence design. This study is conducted on open label because it evaluates PK/PD parameters that are not affected by the blind. Volunteers who are suitable for the inclusion criteria are granted the final target number before the first dosage, receiving a fixed IP, and conducting a planned clinical trial schedule.

After having a rest period (7 days) in which the drug received is sufficiently metabolized and lost, the IP of the next period is administered.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male adults ≥ 19 years of age at the time of the screening procedure
2. 18.5 ≤ body mass index (BMI) ≤ 27.0
3. Voluntarily decided to participate in the study and provided written consent prior to the screening procedure after receiving a detailed explanation on this study and fully understanding the information
4. Is eligible to participate in the study at the discretion of the investigator by a physical examination, laboratory test, and medical history questionnaire, etc.

Exclusion Criteria:

1. Presence or prior history of a clinically significant hepatic, renal, nervous, respiratory, endocrine, hematologic and oncologic, cardiovascular, urogenital, psychiatric disorder
2. Presence or prior history of a gastrointestinal disorder (e.g., gastrointestinal ulcers, gastritis, stomach cramps, gastroesophageal reflux disease, Crohn's disease, etc.), or prior history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the safety and PK/PD assessment of the study drug.
3. Hypersensitivity to, or history of clinically significant hypersensitivity to drugs including DWP16001 and other drugs of the same class (SGLT2 inhibitors), drugs including gemigliptin and other drugs of the same class, metformin and other drugs (aspirin, antibiotics, etc.)
4. Considered ineligible for the study by the investigator for reasons including laboratory test results
JC Virus Reactivation in Multiple Sclerosis

JC virus is a benign virus which infects approximately up to 90% of the normal adult population. However, it may be reactivated in people who have a decreased immune function as in HIV infection, cancer, chemotherapy, transplant recipients, or in MS patients treated with natalizumab (Tysabri). In these patients, JC virus can cause a severe brain disease called Progressive Multifocal Leukoencephalopathy (PML), for which there is no cure.

As of September 2013, 400 MS patients in the world, who have been treated with natalizumab, have developed PML. The risk of PML is approximately 5 patients in 1000 after 24 months on the drug. Researchers do not know exactly in which cells of the body the virus lives but it has been isolated from the blood, urine, cerebrospinal fluid (CSF), and from the brains of patients with immunosuppression.

In this study, the investigators wish to determine precisely where the virus lives, and how the body prevents it from causing brain disease.

Because of the association of PML with natalizumab, the investigators would like to see if there is a difference in the amounts of virus in blood, urine, and CSF found in MS patients treated with natalizumab or those treated with different medications for MS, or those not treated at all. The investigators hope that this knowledge will allow us to find better ways of preventing the development of PML as well as treatments for patients with PML.

Subjects selected for participation in this study have been diagnosed with Multiple Sclerosis (MS). Of the MS patients enrolled in the study, some have been treated with natalizumab or a different medication for MS, and others have not been treated at all. All MS patients enrolled have their blood tested for the presence of the JC virus. Those testing negative for the JC virus do not continue in the study. Those testing positive for the JC virus continue participating in the study, and provide a urine sample, blood sample, lumbar puncture, and a neurological exam. Approximately 65 people will take part in this study at Beth Israel Deaconess Medical Center.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Multiple Sclerosis, relapsing remitting

Exclusion Criteria:

* JCV sero-negative
Efficacy and Safety Study of BG00012 With Methotrexate in Patients With Active Rheumatoid Arthritis

The purpose of this study is to investigate whether the drug BG00012 can improve the symptoms of rheumatoid arthritis (RA) in patients who are already taking methotrexate for RA, but who still suffer symptoms of RA. The purpose is also to ensure that the combination of methotrexate is safe for patients to take and that any side effects are acceptable to patients with RA.

The study is a double-blind, placebo-controlled study of BG00012 plus methotrexate, versus methotrexate alone, in patients with active RA, who have had an incomplete response to other conventional disease modifying anti-rheumatic (DMARD) therapy.

Eligibility Criteria:
Inclusion Criteria:

* must be taking methotrexate
* inadequate response to at least one conventional DMARD
* swollen and tender joint count

Exclusion Criteria:

* previous treatment with TNF or any other biologic or prosorba column

Other criteria also apply.
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study

This trial is a Phase II randomized, double-blind, placebo controlled multi-site study to evaluate the safety and efficacy of early sirolimus to prevent or delay seizure onset in TSC infants.

This study is supported by research funding from the Office of Orphan Products Division (OOPD) of the US Food and Drug Administration (FDA).

Tuberous Sclerosis Complex (TSC) is caused by genetic mutation in TSC1 or TSC2, resulting in dysregulation of the mechanistic target of rapamycin (mTOR) signaling pathway. Age at time of seizure onset in TSC infants has been linked to long-term neurodevelopmental outcome in this high-risk population. Sirolimus is an mTOR inhibitor used to treat many of the symptoms of TSC, including epilepsy. This will be the first study to truly evaluate a targeted, disease-modifying drug therapy for preventing or delaying seizure onset in TSC using a rational, mechanism-based therapeutic approach.

Eligibility Criteria:
Inclusion Criteria:

1. 0-6 months of age at the time of enrollment (subject must be \<7 months of chronological age at time of randomization and treatment initiation). Corrected age must be at least 39 weeks (calculated by subtracting the number of weeks born before 40 weeks gestation from the chronological age).
2. Has a confirmed diagnosis of TSC based on established clinical or genetic criteria

Exclusion Criteria:

1. Prior history of seizures (clinical or electrographic) at the time of enrollment or identified on baseline EEG.
2. Has been treated in the past or is currently being treated at the time of enrollment with conventional anticonvulsant medications (AEDs), systemic (oral) mTOR inhibitors (such as rapamycin, sirolimus, or everolimus), ketogenic-related special diet, or another anti-seizure therapeutic agent, device, or procedure.
3. Has taken any other investigational drug as part of another research study, within 30 days prior to the baseline screening visit.
4. Has a significant illness or active infection at the time of the baseline screening visit
5. Has a history of significant prematurity, defined as gestational age \<30 weeks at the time of delivery, or other significant medical complications at birth or during the neonatal period that other than TSC would convey additional risk of seizures or neurodevelopmental delay (i.e. HIE, severe neonatal infection, major surgery, prolonged ventilatory or other life-saving supportive care or procedures).
6. Abnormal laboratory values at baseline (i.e., renal function, liver function, or bone marrow production) that are in the opinion of the investigator clinically significant and may jeopardize the safety of the study subject.
7. Prior, planned or anticipated neurosurgery within 3 months of the baseline visit
8. Has a TSC-associated condition for which mTOR treatment is clinically indicated (i.e. SEGA or AML).
9. Subjects who are, in the opinion of the investigator, unable to comply with the requirements of the study.
Oral Metformin for Treating Melasma in Latin American Women

The goal of this clinical trial is to learn if metformin can treat melasma in Latin American women. The main question it aims to answer is:

- Can metformin help reduce the dark patches of melasma?

Researchers will test two different doses of metformin (500 mg and 1000 mg) to see if either one helps improve melasma.

Participants will:

* Take a metformin pill every day for three months.
* Go to the clinic twice: once at the beginning and once at the end of the study.
* Get a phone call from the researchers to check how they're doing and ask about any changes or side effects.


Eligibility Criteria:
Inclusion Criteria: Latin American women aged 21 years or older, diagnosed epidermal or mixed melasma

Exclusion Criteria: pregnancy, breastfeeding, use of hydroquinone or tretinoin within 2 months before the study, or undergoing laser treatment, peels, microdermabrasion, or microneedling within 2 months of the study. Patients with a history of renal or liver disease, metformin allergy, diabetes, hypoglycemia, or those on medications that could interact with metformin will also be excluded.
Effects of Ladder Versus Balance Training on Dynamic Balance and Performance Among Football Players

Football is becoming more and more popular around the world since it is easier to obtain. Depending on specific game activities, a player's position on the field may have an impact on their physical traits. Ladder and Balance training is a well-recognized technique for improving players' multidirectional footwork and dynamic balance-both crucial for the rigorous demands of football. The objective of this study is to determine the effects of ladder versus balance training on dynamic balance and performance of football players.

The study design is Randomized Clinical Trial (RCT). The sample size was calculated from epitool software. This study would include total n= 20 participants which would be divided equally into Group A- ladder Training (n=9) and Group B-balance Training (n=9). The study will be conducted in Bahria Football Academy. Modified Star Excursion Balance Test (SEBT) assesses dynamic balance while performance include Vertical Jump, Dribbling, 30m Sprint, and Illinois Agility evaluation at baseline and after 6th-weeks. The data will be analyzed using SPSS version 28.

This study investigates the comparative effects of ladder training and balance training on dynamic balance and performance in football players. The research aims to understand how these distinct training modalities impact dynamic balance and overall performance, providing valuable insights for coaches and athletes. The goal is to tailor training regimens to optimize specific athletic aspects essential in football, contributing to the evidence base for designing more effective protocols in football player development.

Eligibility Criteria:
Inclusion Criteria:

* Male Football Players
* Age 18 to 25 Years
* Participants who regularly trained in football
* Participants who were from various amateur football teams participated in the study

Exclusion Criteria:

* Participants who had an injury in the previous six months
* Participants who underwent any surgery with in last one year
* Participants were excluded if they reported any current injury that limited daily activity
Plus Deep Water Running on Low Back Pain

Objectives: To evaluate the effect size on non-specific chronic low back pain (CLBP) of evidence-based physiotherapy (EBP) with and without the addition of deep water running (DWR) on pain, physical disability and general health state.

Materials and methods: Randomized, double-blind, controlled trial (therapists and assessors) involving 46 persons with CLBP over 15 weeks with two interventions, presented three times a week. Each group received EBP (personalized exercise program, manual therapy and health education) while one group performed supplementary 20 min sessions of DWR at the individualized aerobic threshold. Measurements were made pre and post intervention for pain, disability and general health. Range of motion of lumbar spine in the sagittal plane, maximum isometric strength and muscle endurance of lumbar and hip extensors was assessment.


Eligibility Criteria:
Inclusion Criteria:

* Participants were diagnosed with non-specific CLBP, with no radiation to the legs, and lasting at least three months

Exclusion Criteria:

* Low back pain as a result of specific spinal disease, infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or caudal equine syndrome
* Patients not able to follow instructions
* Patients with any digressive condition