cyrilzakka/clinical-trials huggingface dataset:
Adaptation of the STEPPING ON Fall Prevention Program for Older Adults Receiving Cancer Therapy

Chronic disease self-management is the ability of the individual, in conjunction with family, community and healthcare professionals to manage symptoms, treatments, lifestyle changes and psychosocial, cultural and spiritual consequences associated with a chronic condition. Self-management strategies have been successfully used in supportive care and survivorship in oncology. Stepping On, a multi-component program using a small-group learning environment, reduces falls by 31%. It empowers participants with knowledge about fall-risk, exercise, medications and environmental hazards to self-manage their risk of falls over 7 weeks of educational sessions, followed by a home visit. The research in this proposal will yield the adaptation of the effective group-education-based fall-prevention intervention Stepping On, tailored to cancer patients, feasible for testing in a multi-institutional trial, and ultimately scalable in the oncology setting.


Eligibility Criteria:
Inclusion Criteria for Patient Participants:

* Age ≥70 years.
* Reports a fall within the past 1 year OR self-reports that they are concerned about falling.
* Receiving systemic cancer therapy (including conventional chemotherapy, novel/targeted agents, immunotherapy, monoclonal antibody therapy, oral tyrosine kinase inhibitors, or hormonal agents) OR will begin systemic therapy within the next 4 weeks.
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria for Patient Participants:

* Life expectancy \<6 months.
* Unable to understand written or spoken English.
Peng Block or Suprascapular Nerve Block for Postoperative Analgesia in Shoulder Artroscopy ?

Arthroscopic shoulder surgery, which has been frequently applied in recent years, provides long-term positive clinical results and increases the quality of life after surgery, while it can cause severe pain in the early postoperative period. Postoperative pain management is very important in shoulder arthroplasty. Adequate pain control; mental state, nutrition, cost of care, rehabilitation, and patient satisfaction, are of great importance for the patients' recovery and contribute to a successful surgical outcome.

In this study, the investigators aimed to compare the effects of suprascapular nerve block and shoulder pericapsular nerve block, which will be performed preoperatively with ultrasound, on the level of postoperative pain in patients who will undergo shoulder arthroscopy surgery under general anesthesia.

As a result of the power analysis the investigators conducted for this study, the minimum sample size was calculated as 32 people for each group, 64 people in total, at the 90% confidence interval.

64 patients who meet the inclusion criteria will be included in our study. The participants will be randomized and divided into 2 groups. Accordingly, the PENG block will be applied to 32 patients, and the suprascapular block will be applied to 32 patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who will have shoulder arthroscopy surgery under general anesthesia
* Ages of 18-75
* ASA I-III

Exclusion Criteria:

* Patients with deformity and pathology in the shoulder region
* Patients with known local anesthetic allergy
* Patients with BMI\>35
* Patients with alcohol and substance addiction
* Patients with opioid addiction
* Patients who cannot perceive and evaluate pain, such as psychiatric illness, mental retardation
Ramipril - Hypertension

Primary objective:

Mean values of systolic and diastolic office blood pressure

Secondary objectives:

Total mortality, occurrence of cardio- and cerebrovascular events, change of mean blood pressure (ABPM : Ambulatory Blood Pressure Monitoring) during the observation


Eligibility Criteria:
Inclusion Criteria:

* no previous antihypertensive therapy
* high-normal blood pressure according to the JNC-VI definition (systolic 130 - 139 and/or diastolic 85 - 89 mmHg)

Exclusion Criteria:

* antihypertensive therapy
* blood pressure greater 140/90 mmHg or ABPM greater 135/85 mmHg
Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in ICSI

GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles. Finding a protocol that can be a better alternative will help in improving the success rate of IVF/ICSI cycles

Progesterone has potent restraint on hypothalamus-pituitary-ovarian axis. It acts on unidentified hypothalamic pulse oscillator neurons. In turn, it acts on gonadotropins releasing hormone (GnRH) secreting neurons leading to inhibition of GnRH secretion. This results in inhibition of both luteinizing hormone (LH) and follicle-stimulating hormone (FSH) secretion from anterior pituitary. The effect of progesterone appears to decrease GnRH pulse frequency which results in slowing down LH pulse frequency and reducing LH plasma concentrations

Eligibility Criteria:
Inclusion Criteria:

1. All patients should be candidates for ICSI.
2. Age between 20-40 years.
3. Body mass index 18-35 kg/m2.
4. Diagnosis of PCOS according to modified Rotterdam's criteria

Exclusion Criteria:

* 1) Any patient with contraindication to IVF treatment or pregnancy 2) Women with history of intra-uterine abnormality. 3) Severe endometriosis (grade 3 or 4) 4) Clinically significant systemic disease or other endocrinopathy.
Taurine Eye Drops May Prevent the Progression of Cataract

The aim of the current intervention study is to determine the effectiveness of taurine containing eye drops (available under brand name VIZILOTON) to prevent the progression of grade I and II senile cataract.

This study could answer:

* Dose continuous use of taurine-containing eye drops could prevent further deterioration of vision in mild cases of cataract?
* The acceptance/ compliance of participants to taurine-containing eye drops.
* Could long-term use of taurine-containing eye drops cause adverse effect(s)?

Participants will:

* Take taurine-containing eye drops (VIZILOTON eye drops) 4 times a day for one year.
* Visit eye clinic every 3 months for assessment and visual examination.
* Keep notes for their symptoms and their adherence to treatment.


Eligibility Criteria:
Inclusion Criteria:

* The presence of grade I or II senile cataract on one or two eyes.

Exclusion Criteria:

* clinical signs of glaucoma
* history of amblyopia, eye surgery, argon or YAG laser eye treatment, or major eye trauma
* history of iritis, retinal crystalline deposits, or optic nerve disease
* visually significant fundus pathology
PTSD Clinical Team Research Clinic (PCT Research Clinic)

Part of the IRB_00136053 study was to look at the effectiveness of Warrior Renew and Warrior Renew+EAL interventions. Furthermore, demographic information on Veteran participants will be analyzed.

EAL is one of a group of equine-assisted services (EAS), which are aimed at providing benefits for humans, including addressing emotional, mental and social components of functioning. In recent years, the use of EAS has grown rapidly in Europe and the United States in general and is being increasingly used for active-duty military and veteran Veteran populations. As we have previously reviewed, there is evidence that EAS, such as EAL, can contribute to reduction of PTSD and other psychological symptoms as well as enhancing well-being via improvements in resilience, life satisfaction, trust, self-image, and self-control, as well as quality of life.

Eligibility Criteria:
Inclusion Criteria:

* referred to PTSD team

Exclusion Criteria:

* None
Early Risk Stratification of Patient Hospitalized for SARS-CoV2 Infection: Critical COVID-19 France CCF

The COVID-19 pandemic of SARS CoV2 (Severe Acute Respiratory Syndrome, COVID-19) infection, which is currently evolving in France, raises many questions about the clinical and biological profile of infected hospitalized patients. If certain biological factors like troponin, BNP (Brain Natriuretic Peptid), or clinical factors like cardiovascular history or oncological history are associated with a worse prognosis, available data comes from studies in Asia for the majority, or including a limited number of patients. Patient stratification remains a major issue for patient sorting and early referral of patients.

This study is observational, multicenter and retrospective, and is conducted in hospitals in France.

Clinical data relating to history, comorbidities, risk factors, previous treatments, treatments during the hospitalization and treatments at the discharge from hospital, clinical parameters, biological and ultrasound cardiological data, procedures and events during hospitalization will be recorded, in order to identify the early predictors of clinical worsening in patients hospitalized for COVID-19 in cardiology or conventional medicine department.

Eligibility Criteria:
Inclusion Criteria:

- Patients hospitalized in cardiology unit or medicine conventional sector with diagnosis of COVID-19 (positive PCR (Polymerase Chain Reaction) or diagnosis presumed by the clinical and radiographic picture)

Exclusion Criteria:

* Minors
* Pregnant women
StrataXRT in Preventing Radiation Dermatitis in Pediatric Patients Undergoing Radiation Therapy to the Brain or Spinal Cord

This phase I trial studies the side effects of a silicone topical wound dressing (StrataXRT) and to see how well it works in preventing radiation dermatitis (skin burns and side effects caused by radiation) in pediatric patients undergoing radiation therapy. StrataXRT may help prevent or decrease severe skin rash, pain, itching, skin peeling, and dry skin in pediatric patients undergoing radiation therapy to the brain or spinal cord.

PRIMARY OBJECTIVES:

I. To estimate the safety (defined using the Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0) of StrataXRT and placebo by assessing gel-associated toxicities among pediatric patients, aged 2-17 undergoing proton cerebrospinal irradiation (CSI) for central nervous system (CNS) tumors.

II. To estimate the efficacy of StrataXRT as a preventative agent for radiation-associated dermatitis among pediatric patients, aged 2-17 undergoing proton CSI for CNS tumors.

SECONDARY OBJECTIVES:

I. To explore the relationship between dosing and the efficacy of StrataXRT. II. To explore the relationship between the use of StrataXRT and parent-reported symptom experience, as measured by the Radiation-Induced Skin Reaction Assessment Scale (RISRAS).

III. To explore compliance with the application of treatment as documented in a study log by participants.

OUTLINE:

Beginning first day of CSI proton radiation therapy, caregivers apply StrataXRT gel to half of the patient's forehead and one ear and placebo to the other half of the forehead and the other ear twice daily (BID) until the last day of radiation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients between the ages of 2 years old and 17 years old
* Patients diagnosed with primary CNS tumors including medulloblastoma, pineoblastoma, ependymoma, intracranial germ cell, glioma or intracranial sarcoma who will be starting proton CSI
* Patients planned to receive at least 20 Gy CSI at 1.8 - 2.0 Gy per fraction
* Patients with an identified adult (aged 18 years or older caregiver)(familial or other) who consents to apply the StrataXRT and placebo twice a day for the duration of the study and complete the study instruments
* Informed consent by parents or legal guardian; consent documents will be translated with non-English speaking participants

Exclusion Criteria:

* Patients who have already started proton CSI treatment
* Patients receiving \> 10 fractions photon therapy
* Patients with pre-existing dermal scarring, as determined by a clinical member of the study staff
* Patients who only have a primary caregiver who is a minor (e.g. mother under the age of 18)
* Patients planned to receive less than 20 Gy CSI at 1.8-2.0 Gy per fraction
Safety of Stool Transplant for Patients With Difficult to Treat C. Difficile Infection

The purpose of this study is to test the safety of FMT in patients with C. difficile and cancer. In previous other studies, FMT has been shown to cure C. difficile when antibiotics have failed, but most of these studies have not included patients with cancer. The investigators want to prove that FMT is safe in this group of people so that doctors will feel more comfortable prescribing it for their patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years old
* Patients with solid organ malignancy who have received chemotherapy within the past six months.
* Clinical and microbiologic relapse of C. difficile associated diarrhea after at least one course of adequate antibiotic therapy or refractory disease that does not respond to treatment.

  * At least 10 days of vancomycin at least 125mg QID, or metronidazole 500mg TID
  * C. difficile associated diarrhea is defined as: ≥3 loose or watery stools per day for at least 2 consecutive days or ≥8 loose stools in 48 hours and Positive Clostridium difficile PCR
* Life expectancy of \>3 months.

Exclusion Criteria:

* Expected prolonged compromised immunity

  * HIV infection with CD4 count \<240
  * History of hematopoietic stem cell transplant (HSCT)
  * Hematologic malignancy
  * ANC \<1000/mm3
* Contraindications to anesthesia for procedure

  * Serious cardiopulmonary comorbidities
  * Inability to tolerate anesthesia
  * HGB \<8 g/dL
* Risk of bleeding during procedure

  * PLT \<50,000 K/mcL
  * INR \>1.5 INR
* Pregnancy

  o Pregnant patients will be excluded from this study.
* Gastrointestinal (GI) contraindications

  * Inflammatory bowel disease
  * Active fistula
  * Small bowel obstruction
  * Ileus
  * Gastroparesis
  * Nausea and vomiting
  * Gastrointestinal surgery within the previous 3 months
Covid-19 Infection and Pulmonary Distress Treatment With Zanubrutinib in Hospitalized Participants

The primary objective of this study was to evaluate if the addition of zanubrutinib to supportive care increases the respiratory failure-free survival rate at Day 28 in participants hospitalized for Corona Virus Disease 2019 (COVID-19) and pulmonary distress not receiving mechanical ventilation.


Eligibility Criteria:
Key Inclusion Criteria:

1. Hospitalization for COVID-19 infection
2. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR)
3. Participant requires supplemental oxygen for pulmonary distress related to COVID-19 infection, and has been on supplemental oxygen for no more than 96 hours from time of screening

Key Exclusion Criteria:

1. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
2. On a Bruton's tyrosine kinase (BTK) inhibitor
3. Planned or concurrent use of a host modifiers/immune-based therapies or anti-CD20 monoclonal antibody treatment
4. Participants with prior of current hematologic malignancy or solid tumor malignancy with treatment within 6 months prior to study entry

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Pharmacogenetic Determinants Of Treatment Response In Children

To investigate whether genetic polymorphisms in genes encoding proteins involved in the metabolism or effects of drugs or environmental agents influence the disposition or effects of these xenobiotic substrates. To investigate the nature of heritability and the genetic basis of pharmacogenetic traits by studying family members of individuals with specific genotypes.

Pharmacogenetics is that discipline devoted to elucidating the genetic determinants of drug response. Particularly in the area of drug metabolism, many genes exhibit genetic polymorphism; that is, a stable percentage of the population (which generally differs by ethnic group) is deficient in the functional expression of the enzyme involved, and the deficiency is typically inherited as an autosomal recessive trait. With currently known polymorphisms in drug metabolism, the percentage of homozygous deficient individuals ranges from 0.3% to as many as 90% of the population, depending on the enzyme and the ethnic group.

Our prior studies have revealed multigenic pharmacogenetic models that are significantly predictive of various drug response phenotypes (e.g., drug resistance, drug clearance, drug toxicity, disease response) in children with ALL. The large number of candidate loci and the relatively small number of patients illustrate the fact that larger sample sizes are required to definitively establish these polygenic models. The fact that there were significant race/genotype interactions, such that predictions differed in whites vs blacks, highlights the need for adequate numbers of patients within racial and ethnic groups to allow differential analysis of genotypic predictors after adjusting for confounding demographic factors in pharmacogenetic studies via stratified design and analyses.

Eligibility Criteria:
Inclusion Criteria:

* Any patients under evaluation/treatment at St. Jude Children's Research Hospital (SJCRH)
* Parents or family members of St. Jude patients
* Non patient volunteers
* All study subjects must provide informed consent for participation
* Assent/Consent of the patient (parent) must be provided prior to attempts made by investigators to enroll a family member of a SJCRH patient

Exclusion Criteria:
Tailored Smoking Cessation Intervention in Promoting Sexual and Gender Minority Smokers to Quit Smoking

This trial studies how well tailored smoking cessation intervention works in promoting sexual and gender minority smokers to quit smoking. A program that is specifically designed for the lesbian, gay, bisexual, and transgender community may affect these participants differently than a traditional approach.

PRIMARY OBJECTIVES:

I. To test the feasibility of two different approaches for smoking cessation (print materials developed for smoking cessation among the mainstream population versus \[vs.\] an individualized text based approach) among 60 lesbian, gay, bisexual, and transgender (LGBT) smokers.

SECONDARY OBJECTIVES:

I. To assess the levels of helpfulness, appropriateness, and perceived difficulty of the above mentioned cessation approaches among 60 LGBT smokers.

EXPLORATORY OBJECTIVES:

I. To test the smoking abstinence rates of two different individualized intensive cessation approaches (mainstream vs. individually-tailored) among 60 LGBT smokers.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive mainstream instructional care including brief advice on how to quit smoking, 10-week supply of nicotine replacement therapy (NRT) in the form of nicotine patches, and intensive print materials to promote smoking cessation.

ARM II: Participants receive tailored intensive care including brief advice on how to quit smoking, NRT, and intensive print materials to promote smoking cessation as in Arm I. Participants also receive individualized text based messages to promote smoking cessation for 6 months.

After completion of study, participants are followed up at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Male or female owning a cell phone with a reachable contact number
* Self-identified as LGBT individual, regardless human immunodeficiency virus (HIV) serologic status
* Smoked at least 100 cigarettes in lifetime
* Currently smoking at least 5 cigarettes a day, on average
* Willing to set a quit smoking date within a week of the enrollment
* English speaking

Exclusion Criteria:

* Expired carbon monoxide (CO) levels below 7 ppm
* Positive history of a medical condition that precludes use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining NRT eligibility)
* Current use of NRT or other smoking cessation medications (e.g., varenicline or bupropion)
* Pregnant or nursing
* Enrolled in another smoking cessation program
* Partner enrolled on current study
Prospective Epidemiological Study of Metastatic Non Small Cell Lung Cancer (NSCLC) in Latin America

To describe the overall survival of advanced NSCLC in Latin America.

* To describe demographic and socioeconomic characteristics of patients newly diagnosed with advanced NSCLC
* To describe diagnostic methods, pathological profile and disease stage at diagnosis of advanced NSCLC
* To describe the practice patterns of therapeutic agents for treatment of advanced NSCLC
* To describe treatment responses, progression and survival times.
* To describe reasons for treatment discontinuation
* To identify associations between patient demographics, socioeconomic, pathology, treatment sequences and overall survival;
* To define the patient experience of advanced NSCLC and identify unmet needs in their diagnose and treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older;
2. Newly diagnosed Non-Small Cell Lung Cancer (NSCLC) during the period of the study (which includes 3 months prior to site activation by LACOG, although they can have received anti-cancer treatment during that time);
3. Histologically or cytologically confirmed advanced NSCLC:

   1. Stage IIIB that progressed after curative therapy (chemoradiation and/or surgery);
   2. Stage IV metastatic disease (de novo or distant relapse)
4. Any NSCLC histological subtype and molecular mutation;
5. Any Eastern Cooperative Oncology Group (ECOG) Performance Status (0 to 4) at diagnosis;
6. Patients assigned by treating physician to any therapy (i.e. chemotherapy, targeted agents, immunotherapy) or palliative care;
7. Access to patient medical chart for data collection;
8. Willing and able to provide written informed consent and privacy authorization for the release of personal health information.
Anti-reflux Mucosectomy (ARMS) is a Useful Therapy for Refractory Gastroesophageal Reflux Disease (RGERD)

Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.


Eligibility Criteria:
Inclusion Criteria:

1. Full sufficiency in literacy
2. Be off proton pump inhibitor, antacids and prokinetics ≥ 2 weeks
3. Refractory gastroesophageal reflux disease

Exclusion Criteria:

1. Severe heart, lung, and cerebrovascular disease
2. Severe hematopoietic system disease
3. Abnormal blood coagulation function
4. Oropharyngeal abnormalities
5. Severe spine malformation
6. In pregnancy and lactation at present, or plan to become pregnant within 2 years
7. Severe inflammation or huge ulcers in stomach
8. Mental and psychological disorde
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection.

This study evaluates the use of ABI-1968, a topical cream, in the treatment of cervical precancerous lesions in females without human immunodeficiency virus (HIV) infection.


Eligibility Criteria:
Inclusion Criteria:

1. Women, 25 to 50 years old.
2. Biopsy-confirmed cervical HSIL that is p16+ within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen.
3. Colposcopy is satisfactory based on visualization of the entire squamo-columnar junction (SCJ). The borders of all lesions must be completely visible.
4. The upper limit of the visible (usually aceto-white) lesion is within 3 quadrants or less at screening.

Exclusion Criteria:

1. Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
2. HIV positive (tested at screening visit or within 3 months of screening visit).
3. Resolution of visible CIN lesion prior to enrollment.
4. ECC positive for glandular disease (adenocarcinoma in situ) or invasive cancer.
5. History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.