cyrilzakka/clinical-trials huggingface dataset:
Immunotherapy SBRT Sensitization of the Programmed Death-1 (PD-1) Effect

The purpose of this study is to determine efficacy, safety of Stereotactic Body Radiotherapy (SBRT) in combination with immunotherapy in participants with metastatic non-small cell lung cancer (NSCLC) who are eligible for an immunotherapy agent.

Blockade of the PD-1/PD-L1 T-cell checkpoint pathway is an effective and well tolerated approach to stimulating the immune response which is a critical option in the treatment of metastatic NSCLC. However, progression free survival (PFS) is increased by only 2-4 months and median overall survival (OS) by 3-9 months.

There is compelling evidence that PFS is increased up to 3 fold and OS by 2 fold in patients receiving a course of radiation therapy while on immunotherapy. Radiotherapy is known to induce immunogenic tumor cell death and upregulation of dendritic cells and antigen presentation leading to activation of cytotoxic T-Cells. Dramatic T-cell activation has been demonstrated where tumor regression occurs outside the radiation treatment field in a phenomenon termed the abscopal effect and is associated with high dose radiation delivered via SBRT.

As such, SBRT activation of T-cells could be complementary to immunotherapy and enhance T-cell mediated killing via PD-L1 blockade which could lead to lasting and durable tumor response with improved progression free survival and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed Stage IV NSCLC according to the 7th AJCC staging manual.
* Eligible for an immunotherapy agent. Patients who progress after drug therapy (3 months) for ALK, EGFR or ROS mutation positive lung cancer are eligible.
* At least 2 lesions that are safely amenable to SBRT. ECOG \<=2.
* At least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria for response assessment or at least 1 lesion with FDG avidity and CT correlate that can be monitored for PET-CT response by SUV Max increase or decrease.
* Normal Hepatic and renal function.
* Bone marrow reserve:

  1. ANC ≥ 1.5 x 109/L
  2. Hemoglobin ≥9.0 g/dL
  3. Platelet count ≥75 x 109/L
* Ability to comply with follow-up visits and evaluations, treatment planning and studies and other study related procedures and visits.
* Ability to sign informed consent.

Exclusion Criteria:

* Patients with active CNS metastases
* Active, known or suspected auto-immune disease.
* Patients with medical conditions that require systemic immunosuppression.
* Patients with a history of interstitial lung disease.
* Prior treatment with immune checkpoint inhibitors/immonotherapy.
* Other active malignancy requiring intervention.
* Prior lung radiation, with the only metastatic targets in the lungs.
* Unresolved toxicity from prior chemotherapy or anti-cancer treatment.
* Current or prior enrollment in clinical trial with an investigational drug within 4 weeks.
* Pregnancy or positive pregnancy test.
Randomized, Open-label, Parallel Study to Evaluate the Pharmacokinetic Characteristics of Pregabalin According to Different Controlled Released Formulations in Healthy Male Subjects

The purpose of this trial is to compare the pharmacokinetic characteristics of YHD1119 A, YHD1119 B, YHD1119 C and Lyrica capsule.

YHD1119 A, B, C are controlled released formulations which are made by YUHAN Corporation.

Primary endpoints are C max,ss and AUC tau. Secondary endpoints are AUC last, AUC infinity, T max,ss, t 1/2


Eligibility Criteria:
Inclusion Criteria:

* 20\~45 years old, healthy adult male subject
* \>55 Kg(Body weight) and \< ideal body weight ± 20%

Exclusion Criteria:

* AST or ALT \> 1.25 \* Upper normal range (Lab)
* Total bilirubin \> 1.5 \* Upper normal range
* Systolic BP \>140 OR \<100, Diastolic BP \>90 OR \<65
Evaluate the Safety and Effectiveness of Various Frequency Stimulation for Patients With Parkinson's Disease

Patients with an implantable electrical nerve stimulation system Patient criteria included: over 18 years of age,MMSE≥ 24 score; H-Y stage in medicine off condition\>2.0;an ability to walk at least 10 meters independently;subscore≥2 for UPDRS part II item 15;subscore \>1 for UPDRS part II item 14; permissions given by informed consent. Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials. Subjects participating in other clinical trials related or not related to these trials were not chosen.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years of age,male or female patients
* idiopathic Parkinson's disease
* had deep brain stimulaton implant
* H-Y\>2.0 in the absence of L-dopa
* UPDRSII-14 item ≥1
* UPDRSII-15 item ≥2
* an ability to walk at least 10 meters independently

Exclusion Criteria:

* Patients with serious diseases such as tumor, sever liver or kidney dysfunction were not selected in the clinical trials
* epilepsy
* Pregnant female
* History of severe neuropsychiatric disease
* Patients are taking part in other clinical trials in recent several months
An Efficiency of a Moisturizer Containing Licochalcone A, L-carnitine and 1,2-decanediol With Adapalene Gel in Acne

Acne is an inflammation of sebaceous glands and follicles. Applying topical treatments such as adapalene gel may cause irritant adverse effects. Hence, using a moisturizer is another way to protect or relieve this undesirable event. Moisturizers that have anti-inflammatory property could reduce irritant effects, emergent from using topical treatment and also reduce severity of acne.

Research teams chose an adapalene gel to act as topical treatment for curing acne. It has anti-inflammatory and comedolytic effects and has fewer side effects than other groups of topical retinoic acids. However, peeling skin, redness skin, tingling sensation or itching sensation may occur if they are continually used for a long period. Thus, for the purpose of studying the efficacy of moisturizer containing licochalcone A, L-carnitine and 1,2-decanediol in reducing irritant effect of using adapalene gel (Licochalcone A has anti-inflammatory effect, L-carnitine decrease sebum production and 1,2-decanediol has anti-bacterial effect).

The investigators team research with patients by separate patients into 3 groups and compare among each other. In the first group use only adapalene gel, the second group use adapalene gel with moisturizer containing three substances mentioned above, and the last group use adapalene gel with placebo moisturizer. To compare outcomes among 3 groups, the investigators will measure degree of redness, scale, oily face, moist, number of acne, quality of life, and satisfaction after using moisturizer.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years old or above
2. Participants have to control the birth for example, condom method, intrauterine device method before participate in the research at least 1 month until 6 months after research finish.
3. being diagnosed acne vulgaris by dermatologist in mild to moderate degree based on Investigators' Global Assessment scale of FDA

Exclusion Criteria:

1. Use oral or injected antibiotics or other oral medicine treating acne for example, isotretinoin, oral contraceptives, or spironolactone group during 4 weeks before participate this research
2. Have other active skin diseases at face during 2 weeks before participate the research
3. Allergic to adapalene gel and moisturizer
4. Have severe or uncontrolled underlying diseases
5. Getting pregnant or during breast feeding
6. Other types of acne(not acne vulgaris)
Skin Health and Effectiveness of Standardized Skin Care Regimens in Nursing Home Residents

Residents of institutional long-term care facilities are at high risk for developing skin and tissue diseases, e.g. xerosis cutis (including pruritus), infections (e.g., tinea pedis, candidiasis), chronic wounds or neoplastic changes (e.g. actinic keratosis, malignant melanoma) but there are few epidemiological figures about the actual frequencies of these conditions in nursing homes. Therefore, in the first part of this study we aim at measuring key dermatological conditions and associated health and functional status, and the skin care practice of aged nursing home residents ("prevalence study").

Basic skin care interventions are believed to reduce skin dryness and to enhance skin health. Thus, the second aim of this study is to investigate the effectiveness of two structured skin care regimens compared to the routine standard skin care on skin health in nursing home residents ("intervention study").

The study will be conducted in a random sample of seven out of approximately 300 institutional long term care facilities of the federal state of Berlin.


Eligibility Criteria:
Inclusion Criteria:

"Prevalence study"

* Living in the nursing home at the time of data collection;
* Being 65+ years;
* Written informed consent (or by legal representative);

Additional inclusion criteria for the "intervention study"

* Overall dry skin score (ODS) of 2 to 4 at the right and left leg;
* Willingness and ability to fulfil the study requirements.

Exclusion Criteria:

"Prevalence study"

* Residents at the end of life (dying persons).

Additional exclusion criteria for the "intervention study"

* Any dermatological condition or skin affection, e.g. acute weeping, excoriated or inflammatory dermatitis, or skin treatment which may interfere with the study assessments at the discretion of the investigator;
* Any unstable acute or chronic pathology or condition that may interfere with the study conduct at the discretion of the investigator;
* Any use of topical drugs on the investigational areas two weeks prior to inclusion;
* Systemic application of corticosteroids, antihistamine or other anti-inflammatory drugs;
* Known allergy or intolerance to any ingredient of the study products, e.g. urea.
Localization of Vasculonervous Structures in Tibial Nerve Neuromodulation: a Cross-sectional Study

Tibial nerve neuromodulation is an effective and widely used technique in various pelvic floor dysfunctions. There are two approaches described in scientific literature to perform this technique: transcutaneous and percutaneous. However, there is no consensus on the execution of these techniques, as the location of the tibial nerve in relation to other anatomical structures like the tibia has not been described. The findings of this research could serve as a basis for the implementation and development of protocols aimed at improving the technique of posterior tibial neuromodulation.

Design: A cross-sectional observational study at the Physiotherapy Unit of the Ramón y Cajal University Hospital.

The main objective of this study is to determine the location and size of tibial vasculonervous structures (nerve, artery, and vein) in relation to the tibia and skin using ultrasound in healthy subjects Methods: Healthy subjects will participate, and sociodemographic data (age, sex, weight, height) will be collected. Subsequently, various measurements of the right tibial vasculonervous structures will be obtained through ultrasound A single examiner with over 5 years of experience in ultrasound will perform the measurements.

Significance of the research: Knowledge of the position and size of the tibial vasculonervous bundle could be useful to justify and standardize transcutaneous and percutaneous approaches in tibial nerve neuromodulation. This would improve the safety of the technique, avoiding adverse events resulting from the intervention

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects over 18 years of age

Exclusion Criteria:

* Previous fracture of the distal end of the right tibia
* Previous vascular pathology of the distal end of the right tibia
* Previous nervous condition of the distal end of the right tibia
* Previous surgical intervention of the distal end of the right tibia
* Ongoing oncological process of the distal end of the right tibia
Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD

This study evaluates whether Helicobacter pylori eradication improves precancerous lesions including glandular atrophy and intestinal metaplasia as well as metachronous cancers or dysplasias after endoscopic mucosal resection for gastric cancer.

Helicobacter pylori is a primary etiological agent leading to chronic gastritis and peptic ulcer. The organism is also associated with gastric cancer in epidemiological studies. However detailed mechanism of carcinogenesis remains unknown. Histolopathological studies indicate that chronic H. pylori infection progresses over decades through stages of chronic gastritis, atrophy, intestinal metaplasia, dysplasia and cancer. Gastric atrophy and intestinal metaplasia are considered as precancerous lesions, but whether H. pylori eradication improves these lesions and prevents metachronous gastric cancer is controversial. And the issue has not been evaluated in gastric cancer patients. However, despite the conflicting evidences from two open labelled randomized controlled trials, current guidelines from various regions recommend H. pylori eradication treatment in patients who were treated for gastric cancer by surgically or endoscopically. Thus, it is important to evaluate whether H. pylori eradication can improve known precancerous lesion, i.e. glandular atrophy and intestinal metaplasia in gastric cancer patients. Such histological improvement can eventually reduce secondary gastric cancer development and provide evidence for current guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Early Gastric cancer or high grade dysplasia confirmed by endoscopy

  * Histologically confirmed well or moderately differentiated adenocarcinoma, or high grade dysplasia
  * Submucosal invasion is not suspected
  * No evidence of ulceration or ulcer scar within the lesion
* Helicobacter pylori infection was confirmed by histological evaluation and rapid urease test
* Pre op CT stage: IA (T1N0M0) according to UICC TNM classification system
* Informed consent should be signed

Exclusion Criteria:

* Recurrent gastric cancer
* Previous serious side effect to antibiotics
* H. pylori eradication treatment history
* Poorly differentiated adenocarcinoma or Signet ring cell carcinoma
* Undergoing operation due to complication of EMR
* Undergoing operation due to remnant cancer
* Other malignancy within the past 5 years
* Pregnant or nursing women
* Serious concurrent infection or nonmalignant disease such as liver cirrhosis, renal failure, cardiovascular diseases
* Psychiatric disorder that would preclude compliance
A Single Dose Study to Investigate the Pharmacokinetics of MK-0941 in Participants With Renal Insufficiency (MK-0941-015-02)

This study will assess the pharmacokinetics of MK-0941 in participants with varying degrees of renal insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Male or nonpregnant female age 18 to 75 years
* Female of childbearing potential on appropriate method of contraception
* Body mass index (BMI) less than or equal to 40 kg/m2
* Participant is in good health
* Participant diagnosed with Type 2 Diabetes
* Participant agrees to follow smoking restrictions
* Willing to follow the study diet restrictions

Exclusion Criteria:

* Mental or legal incapacitation
* Participant has had kidney removed
* History of Type 1 diabetes
* History of stroke, chronic seizures or major neurological disorder
* History of neoplastic disease
* Nursing mother
* Consumes greater than 4 glasses of alcoholic beverages per day
* Consumes greater than 6 servings of caffeinated beverages per day
* Participant has had surgery or donated 1 unit of blood within 1 month of screening
* Participant has history of recent eye infection within 2 weeks of study drug administration
* Clinically diagnosed with glaucoma or blindness
* Has trauma to one or both eyes
An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome

To investigate the safety and tolerability of long-term treatment with oral trofinetide in girls with Rett syndrome


Eligibility Criteria:
Inclusion Criteria:

* Female subject

  1. 2 to 4 years of age and body weight ≥9 kg and \<20 kg at Screening OR
  2. 5 years of age and body weight ≥9 kg and \<12 kg at Screening
* Can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube
* The subject's caregiver is English-speaking and has sufficient language skills to complete the caregiver assessments
* Has classic/typical Rett syndrome (RTT) or possible RTT according to the Rett Syndrome Diagnostic Criteria
* Has a documented disease-causing mutation in the MECP2 gene
* Has a stable pattern of seizures, or has had no seizures, within 8 weeks prior to Screening
* Subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 4 weeks prior to Screening

Exclusion Criteria:

* Has been treated with insulin within 12 weeks of Baseline
* Has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study
* Has a history of, or current, cerebrovascular disease or brain trauma
* Has significant, uncorrected visual or uncorrected hearing impairment
* Has a history of, or current, malignancy
* Has any of the following:

  1. QTcF interval of \>450 ms at Screening or Baseline
  2. History of a risk factor for torsades de pointes (e.g., heart failure or family history of long QT syndrome)
  3. History of clinically significant QT prolongation that is deemed to put the subject at increased risk of clinically significant QT prolongation
  4. Other clinically significant finding on ECG at Screening or Baseline

Additional inclusion/exclusion criteria apply. Patients will be evaluated at baseline to ensure that all criteria for study participation are met. Patients may be excluded from the study based on these assessments (and specifically, if it is determined that their baseline health and condition do not meet all prespecified entry criteria).
Effects of Resistance Strength Training on Functional Capacity and Well Being of Anorexic Patients

The purpose of the present randomized controlled trial was to determine the effects of a 3-month resistance training program (2 sessions/week) on the functional mobility and muscle function, muscular dynamic strength, body composition and quality of life of young anorexic outpatients (≤16 years). The investigators also assessed cardiorespiratory variables of clinical significance such as peak oxygen uptake.

A total of 22 outpatients \[20 female (Tanner stage II-IV), 2 male (Tanner stage IV); age range: 12-16 years\] were finally eligible and thus participated in the study.

Participants in the intervention group were enrolled in two training sessions per week for 12 weeks. Each session lasted 60-70 min and started at \~11:30 a.m., after the intra-hospital psychotherapy session. The program was individually supervised, i.e. one instructor for every three patients.

Each session started and ended with a low intensity 10-15min warm-up and cool-down period respectively, consisting of stretching exercises involving all major muscle groups. The core portion of the training session consisted of 11 strength exercises engaging the major muscle groups, i.e. bench press, shoulder press, leg extension, leg press, leg curl, abdominal crunch, low back extension, arm curl, elbow extension, seated row and lateral pull-down. For each exercise, the participants performed one set of 8-15 repetitions (total of \~ 20s duration) with resting periods of 1-2 min between exercises. The load was gradually increased as the strength of each child improved, i.e. from 20-30% of 6 repetition maximum (6RM) at the start of the program to 50-60% of 6RM at the end. Stretching exercises of the muscles involved in the previous exercises were performed during the rest periods (21).

Participants also performed isometric contractions of large muscle groups (6 sets of 3 repetitions each, 20-30s duration per repetition) with their own body weight (for lower body exercises) or barbells (1-3kg) for upper body.

Outcome measures:

* Anthopometry
* Cardiorespiratory fitness
* Muscular strength
* Functional mobility
* Quality of life

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of restrictive anorexia nervosa
* Age ≤ 16 years
* Undergoing intra-hospital psychotherapy and dietary counseling (two visits per week) in this Hospital
* Body mass index \> 14.0 kg/m2

Exclusion Criteria:

* None
Early Versus Delayed BCG Vaccination of HIV-exposed Infants

In sub-Saharan Africa (SSA), more than 300,000 babies with HIV die each year. HIV-infected children develop AIDS and die faster in SSA than those in developed countries. Bacille Calmette-Guerin (BCG) vaccine is given to infants at birth in SSA to protect them from severe forms of TB. BCG is known to cause immune cells to be active and replicate faster. The immune system of neonates also responds differently to BCG that to other vaccines and infections. We hypothesize that the routine immunization of neonates with BCG contributes to generalized immune activation in HIV-exposed infants resulting in skewed immune responses to vaccines and infections and increased rates of disease progression in those infants that become HIV-infected. However, delaying BCG until HIV testing is completed would result in operational difficulties, and may not induce the appropriate immune response. Delayed BCG would also render many HIV-exposed uninfected infants at high risk for disseminated TB. We plan to assess immune cells in infants to determine the impact of the timing of BCG vaccination on immune responses to tuberculosis (TB) and other vaccines. We will also compare the immune activation and disease progression of those infants that become HIV-infected in the BCG or control arms. Our results will provide key insights into the effect of BCG vaccination on immune responses to HIV as well as inform the optimal timing of BCG vaccination for HIV-exposed infants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy neonate
* Maternal HIV
* \> 36 weeks gestation
* Birth weight \> 2.4kg
* Remaining in area 4 months

Exclusion Criteria:

* Complications during pregnancy and delivery
* Household TB contacts