cyrilzakka/clinical-trials huggingface dataset:
A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer

Androgen Deprivation Therapy (ADT) triggers thymic revitalization and increases thymic output, enhancing baseline anti-tumor immunity and responses to immunotherapies. Anti-tumor synergism has been identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors. This study is to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.

Immune checkpoint blockades (ICBs) are widely used in the clinical treatment of lung cancer. Studies have shown that the quantity and function of tumor-infiltrating lymphocytes (TILs) are associated with the effectiveness of PD-1 inhibitors in treating advanced NSCLC. The thymus is crucial for the differentiation, development, and maturation of T cells. With age, thymic atrophy leads to immunosenescence, significantly affecting baseline anti-tumor immunity and responses to immunotherapies. Preliminary findings have indicated that androgen deprivation therapy (ADT) not only directly induces apoptosis in prostate cancer cells but also may exert anti-tumor effects by promoting thymic regeneration. Furthermore, anti-tumor synergism has been identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors. Therefore, this study aims to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.

Eligibility Criteria:
3.Inclusion Criteria:

1. Male patients aged ≥60 years.
2. ECOG performance status score of 0 \~1.
3. Expected survival time of more than 3 months.
4. Histologically or cytologically diagnosed advanced lung cancer according to the TNM staging system established by AJCC.
5. Patients who have not previously received any anti-PD-1 treatment.
6. Patients with adequate bone marrow function, no significant hepatic, renal, or coagulation dysfunction as per laboratory test criteria.
7. At least one tumor lesion meeting the following criteria:

   * No prior local treatments such as radiotherapy
   * Not biopsied during the screening period (if biopsy needed, baseline tumor assessment at least 14 days after the screening biopsy).
   * Measurable at baseline (longest diameter of the lesion ≥10 mm; For a lymph node, short diameter ≥15 mm).
   * If only one measurable lesion, no prior local treatments such as radiotherapy.
8. Ability to understand and voluntarily sign a written informed consent form.
9. Willingness to follow the study protocol and follow-up examinations.

Exclusion Criteria:

* Exclusion of cases that do not meet the inclusion criteria
Research on the Impact of Targeted Subsidies Within Open Defecation Free (ODF) Communities

This study evaluates targeted subsidies as a strategy to improve sanitation infrastructure and behaviours in communities that have reached Open Defecation Free (ODF) status after a Community-Led Total Sanitation (CLTS) program. The investigator's hypothesis is that sanitation subsidies targeted at the most vulnerable households within ODF communities will increase and help sustain latrine coverage, quality, and use amongst the targeted households, and through a spill-over effect, amongst the rest of the community. Half of participating communities will receive the targeted subsidy, while the other half will not receive any treatment.

Community-Led Total Sanitation (CLTS) is a widely used approach to eradicate open defecation in rural communities in developing countries. Using emotional triggers, CLTS promotes community self-help to build household latrines. In Ghana, where CLTS is part of the government's official sanitation strategy, a community is declared "Open Defecation Free" (ODF) when 80 percent of households own a latrine.

There is however evidence that open defecation persists in so-called "ODF" communities, especially as the most vulnerable households (the poorest of the poor) cannot afford to construct or maintain durable latrines. As a result, subsidies for these vulnerable households have been proposed as a strategy to promote the construction of durable latrines and help sustain safe sanitation behaviours in communities having received CLTS.

Eligibility Criteria:
This study is a cluster randomized controlled trial that will enroll entire communities. Within a community, only specific households will be selected to receive sanitation subsidy vouchers. Outcomes will be measured both for voucher recipients and for the rest of the community.

Inclusion Criteria (for Communities):

* Community was targeted by UNICEF's Community-Led Total Sanitation (CLTS) program in Tatale, Yendi, and Kpandai districts in Ghana.
* Community has Open Defecation Free (ODF) status according to local authorities.
* Community has more than 15 and less than 100 households.

Exclusion Criteria (for Communities):

* Community is located less than 2 kilometers away from a community in the opposite treatment arm.

Inclusion Criteria (for voucher recipients within study communities):

* Household is extremely poor, as identified through community consultation and/or the government's Livelihood Empowerment Against Poverty (LEAP) program.
* Household has at least one vulnerable person, i.e. who meets one of the following criteria: i) older than 65 years old, ii) person with a disability, iii) orphan or vulnerable child, iv) female head of household, v) widow(er), vi) terminally-ill persons, vii) unemployed, viii) outcast groups.

Exclusion Criteria (for voucher recipients within study communities):

* Household owns a functional, individual (non-shared) latrine with durable sub-structure.
Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes

The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2 Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks administration in double-blind, placebo-controlled manner. And in addition, the changes in lipid-related parameters are examined.


Eligibility Criteria:
Inclusion Criteria:

* Patients whose fasting blood glucose levels during the observation period are between 130mg/dL and 200mg/dL.
* Patients whose HbA1c is 7.0% or above during the observation period.

Exclusion Criteria:

* Patients with serious cardiac, hepatic or renal complications.
* Patients with serious diabetic complications.
* Patients with complete biliary obstruction or ileus.
* Pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception.
A Study to Assess the Safety of Experimental Medication BMS986165 in Participants With Normal Kidney Function and Participants With Mild to End-Stage Kidney Disease.

The purpose of this study is to investigate BMS-986165 in participants with different levels of kidney function.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Participants must be judged to be in good health in the opinion of the investigator OR participant has a stable disease (eg, hypertension, hyperlipidemia, diabetes mellitus, hyperthyreosis) under medical control (ie, no changes in medication within 30 days prior to study drug administration)
* Stable renal impairment, defined as no clinically significant change in disease status, as documented by the participant's most recent eGFR assessment; eGFR must not vary more than 30% from screening to Day -1 to confirm stable renal function, and the renal impairment must be expected by the investigator not to change significantly during the next 3 months
* Body mass index of 18.0 to 38.0 kg/m2, inclusive, and weight ≥50 kg, at screening

Exclusion Criteria:

* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant
* Have a history of cancer (malignancy) with the following exceptions: (1) subjects with adequately treated non-melanomatous skin carcinoma or carcinoma in situ of the cervix may participate in the trial; (2) subjects with other malignancies that have been successfully treated ≥10 years prior to the screening visit where, in the judgment of both the investigator and treating physician, appropriate follow-up has revealed no evidence of recurrence from the time of treatment through the time of the screening visit
* History or clinical evidence of acute or chronic bacterial infection (eg, pneumonia, septicemia) within 3 months prior to screening

Other protocol defined inclusion/exclusion criteria could apply
Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.

prospective cardio respiratory evaluation for patients post the Fontan palliation for single ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy volunteers in order to evaluate the functional capacity and the primary etiology for reduction in functional capacity.


Eligibility Criteria:
Inclusion Criteria:

* Children at age of 8-25 post fontan palliation
* Patients With Repaired Congenital Heart Disease without chronic lung disease
* Healthy patients ate age of 8-25

Exclusion Criteria:

* Patients with chronic lung disease
* Pregnant women
* Patients with acute active disease or chronic disease that may affect the exercise function
The Registry Evaluating Functional Outcomes of Resynchronization Management

The purpose of this study is to evaluate the functional outcomes of resynchronization management and to describe the patient psychosocial characteristics (depression ad anxiety) and associated outcomes with electrophysiologic device therapy for chronic congestive heart failure.

This project will prospectively enroll all consecutive patients undergoing implantable cardioverter defibrillator (ICD) and ICD with biventricular pacemaker (CRT-D) implantation for heart failure from in-patient and out-patient setting. Primary objective: Compare the psychosocial function and quality of life of ICD patients to Patients receiving CRT-D therapy. Secondary outcome objectives: 1)Determine and compare the change in LVED (left ventricular end distolic) dimension and LVESV (left ventricular end systolic volume)from baseline to 9 month follow up in CRT and ICD patient.2)Determine and compare the change in NYHA (New York Heart Association) classification, KCCQ, optimisim and pessimism, degree of stress, and social support from baseline to 9 month follow up in CRT and ICD patients. Florida Patient Acceptance Survey and Florida Shock Anxiety Scale will be determined and compared at 3 monthe and 9 months.3)Determine and compare Clinical composite score(Packer M 2002)in patient groups where: Worsened-patient dies, improved, unchanged. Inclusion Criteria: Patient referred for device therapy (ICD or CRT-D) for chronic congestive heart failure who are willing and able to give informed consent and participate in follow-up calls. Duration of patient follow up will be 9 months. Statistical Mehtodology: Univariate, Multivariatae, Kaplan-Meier analysis

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with ICD who meet Primary prevention (SCD-HeFT or MADIT II indications.
* Patients implanted with CRT-D indications (i.e. NYHA class III or IV; QRS \> = to 120MS; LVEF \<= TO 35%) patient willing to give informed consent and participate in follow up evaluation.

Exclusion Criteria:

* Non-English speaking patients and patients who are unable to give consent or participate in follow up protocols due to lack of a home phone or unwilling to disclose phone numbers.
* Patients with significant transient neurological impairment before, during or after device implant who have been deemed incompetent to complete the consent process, or who are unable to participate in follow-up evaluation tests.
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia

The study team will assess the efficacy of platelet-rich plasma therapy, a special blood product which is from the participant's own body, in the treatment of androgenic alopecia (also known as male pattern hair loss) in females.

Androgenic alopecia, or male-pattern hair loss affects both men and women. This hair loss pattern is typically characterized by thinning at the crown of scalp and/or M-shaped hair line in males or diffuse thinning throughout in females. Platelet-rich plasma (PRP) therapy has recently been studied as a hair rejuvenation therapy in patients with non-inflammatory alopecia. Though the mechanism of action is not well understood, PRP is thought to promote angiogenesis and enhance blood flow around hair follicles via platelet-derived growth factor (PDGF), transforming growth factor (TGF), and vascular endothelial growth factor (VEGF). The primary objective of the study is to determine whether PRP, administered once monthly for 3 months improves clinical outcomes and quality of life in females with androgenic alopecia. This is a randomized, placebo-controlled, double-blind, half-head, single center clinical study where sixteen subjects with androgenic alopecia will be recruited. Dermatology Life Quality Index will be assessed at several time points. Disease severity will be measured using the Severity of Alopecia Tool (SALT), Alopecia Density and Extent Score (ALODEX); Trichoscan images will be captured to document participants' clinical progress. Adverse events will be recorded at each visit, treatment will be discontinued if any subject experience a serious adverse event. Treatment visits will take place at baseline, 4 weeks (1 month), 8 weeks (2 months), and 12 weeks (3 month). A follow-up, non-treatment visit will take place at 24 weeks (6 months). The study team hypothesizes that PRP will improve DLQI, SALT, ALODEX, hair count (number of hairs/0.65 cm2), hair density (number of hairs/cm2), hair diameter, anagen to telogen ratio, and vellus hair to terminal hair ratio in female subjects with androgenic alopecia.

Eligibility Criteria:
Inclusion Criteria:

* Female ≥18 years of age at baseline visit.
* Documentation of androgenic alopecia diagnosis as evidenced by one or more clinical features
* Not currently on any treatment for alopecia, or has undergone 2-week washout period if recently on medication(s) for alopecia
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study

Exclusion Criteria:

* Pregnant or breastfeeding
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Have an infection, metastatic disease or certain skin conditions (ie. Psoriasis) which could worsen or spread with injections
* Diagnosed with a blood or bleeding disorder
* Diagnosed with anemia
* Currently on anticoagulant therapy
Moexipril HCL/Hydrochlorothiazide 15/25 mg Tablets Under Fasting Conditions

The objective of this study is to compare the relative bioavailability of Moexipril HCl/hydrochlorothiazide 15/25 mg tablets (manufactured and distributed by TEVA Pharmaceuticals USA) with that of UNIRETIC® 15/25 mg tablets (Schwartz Pharma) in healthy, adult non-smoking subjects under fasting conditions.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* All subjects selected for this study will be non-smokers at least 18 years of age.
* Subjects will have a BMI index (body mass index) of 30 or less.

Exclusion Criteria:

* Subjects with a history of chronic alcohol consumption (during past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic, tuberculosis, epilepsy, asthma (during past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
* Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result not to be significant.
* Subjects who have a history of allergic responses to the class of drug being tested should be excluded from the study.
* All subjects will have urine samples assayed for the presence of abuse as part of the clinical laboratory screening procedures and ath check-in each study period. Subjects found to have urine concentrations of any of the tested drug will not be allowed to participate.
* Subjects should not have donated blood and/or plasma for at least thirty (30) days prior to the first dosing of the study.
* Subjects who have taken an investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
* Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
* All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be withdrawn from the study.
* Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
* Subjects who do not tolerate venipuncture will not be allowed to participate.
Effect of Soft Tissue Mobilization With and Without Neural Mobilization in Cervical Radiculopathy

This study will evaluate effect of soft tissue mobilization with and with out neural mobilization in cervical radiculopathy, half of the subjects will receive treatment of soft tissue mobilization along with neural mobilization whereas half of the subjects will receive only soft tissue mobilization.

soft tissue mobilization and neural mobilization both treatments are used to treat cervical radiculopathy but they work differently.

Soft tissue mobilization include traction which decompresses the nerve and stretches the surrounding muscles along with help to reduce pain and tingling sensation. whereas hot pack helps to increase blood circulation and warm up muscles and isometric exercises provide strengthening and build endurance.

Neural mobilization technique is different for all 3 nerves i.e Radial, ulnar and median. neural mobilization technique target the single nerve which is being compressed and showing symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients with age 18 to 55years
* Patients having pain more than 3months
* Radiating pain in one of the upper limb
* Spurling's test positive

Exclusion Criteria:

* Traumatic injury of upper limb or cervical spine
* Vertebral artery test positive(dizziness, vomiting, diplopia, drop attacks etc)
* Patient asymptomatic for pain but symptomatic for tingling and paraesthesia
* Circulatory disturbance of upper extremity
* Known history of high level of spinal cord injury and malignancy
* Thoracic Outlet syndrome
Study To Investigate Patient Preference On Dosing In Ibandronate And Risedronate In Korean Women With Postmenopausal Osteoporosis

This is a randomized open label, multi-centre study for Korean women with postmenopausal osteoporosis, evaluating the preference for either the once-monthly dosing of ibandronate or the once-weekly dosing of risedronate.

Eligible subjects will be randomised either ibandronate monthly regimen or risedronate weekly regimen.

Treatment period consists of 3 month with ibandronate 150mg and additional 12 week with risedronate 35 mg or vice versa.

After taking the first interventional medicine for 3 months or 12 weeks completely, a subject changes the treatment arm. There is no washout period.


Eligibility Criteria:
Inclusion Criteria:

* Women with postmenopausal osteoporosis diagnosed by DXA scanning, defined by T-score of -2.5 SD at spine or femur.
* Patients who have never received bisphosphonates therapy (bisphosphonates naive)

Exclusion Criteria:

* Inability to stand or sit in the upright position for at least 60 minutes;
* Hypersensitivity to any component of risedronate and ibandronate;
* Administration of any investigational drug within 30 days preceding the first dose of the study drug;
* Patient has been on hormone (estrogen) replacement therapy or other osteoporosis medication (e.g. SERMS and calcitonin) within the previous 3 months.
* Patient has been on systemic corticosteroids therapy for more than 1 month within the past year.
* Other bone disease except osteoporosis
* Current medical history of uncontrolled major upper GI disease
A Ring-type Wearable Device for Atrial Fibrillation

This study investigates diagnostic performance of a ring-type wearable device for detecting atrial fibrillation. This is a prospective cohort registry study began after the date of IRB approval and until 31th Dec. 2019. The eligible criteria are (1) those who admitted the institution for elective direct-current cardioversion of persistent atrial fibrillation, and (2) aged 19 years or more. The exclusion criteria are (1) those aged less than 19 years, (2) those who are not eligible to perform cardioversion by any reasons. This study aims to recruit 200 participants in total. The participants are required to record photoplethysmographic signals by the ring device in addition to routine procedures of direct-current cardioversion, hence, the study is at minimal risk.

1. Study title: Diagnostic Performance of a Ring-type Wearable Device Using Deep Learning Analysis of Photoplethysmographic Signals for Detecting Atrial Fibrillation.
2. Study type: Investigator initiated study.
3. Study design: Prospective observational cohort registry design.
4. Sponsor: Sky Labs, Inc., Republic of Korea.
5. The aim of the study: To evaluate diagnostic performance of a ring-type wearable device for detecting atrial fibrillation.
6. Study period: From the date of IRB approval to 31th Dec. 2019.
7. The size of study population: 200 participants
8. The eligibility criteria:

(1) Those with persistent atrial fibrillation (2) Those who admitted the institution for elective direct-current cardioversion (3) Those aged 19 years or more 9. The exclusion criteria:

(1) Those with other forms of cardiac arrhythmias (2) Those aged less than 19 hears (3) Those who are not eligible to perform electrical cardioversion 10. Procedures of the study

1. A participant is under the routine procedures of direct-current cardioversion.
2. On admission, a participant is given with detailed information of the study.
3. After the informed consent, the only additional procedure due to the study is recording photoplethysmographic signal by wearing a ring-type device.
4. Recorded signals are evaluated without encompassing persornal information. 11. Financial benefits to the participants: None.

Eligibility Criteria:
Inclusion Criteria:

* Those with persistent atrial fibrillation
* Those who admitted for elective direct-current cardioversion
* Those who aged 19 years or more

Exclusion Criteria:

* Those who aged less than 19 years
* Those who had other types of cardiac arrhythmias
* Those who are not eligible to perform electrical cardioversion