cyrilzakka/clinical-trials huggingface dataset:
Physical Activity Referrals to the Community

The purpose of this study is to determine the impact of primary care referrals to community physical activity programs for overweight and obese youth aged 6-18 years on objectively measured physical activity and cardiorespiratory fitness, as well as other cardiovascular health indicators. We hypothesize that physical activity referrals will result in higher levels of physical activity and fitness.


Eligibility Criteria:
Inclusion Criteria:

* Aged 6-18 years
* Body mass index greater than or equal to the 85th percentile for age and sex or greater than or equal to 25 for youth aged 18
* Fluent in English
* Parent of participant must be fluent in either English or Spanish

Exclusion Criteria:

* Medical conditions that preclude participation in physical activity
MagDI U.S. Registry

Assess the incidence and severity of internal hernia and bowel obstruction at one year in a U.S. population following use of the MagDI System to create side-to-side duodeno-ileal anastomoses.

Small bowel obstruction (SBO) following various abdominal and pelvic surgeries (0.4% - 13.9% at 5 years post-surgery) across obese and non-obese patients has been well studied in the scientific literature and found to be primarily due to intraperitoneal adhesions, with surgical technique (open surgery versus laparoscopic) cited as a key risk factor as reported in a retrospective population-based registry in Sweden (n=108,141). SBO incidence was reported as 3.2% for those undergoing bariatric surgery (n=1,896).

Given the MagDI System premarket clinical study (GTM-001) was conducted outside the U.S., FDA requires one post-market surveillance study to assess and characterize the incidence and severity of internal hernia and bowel obstruction in the U.S. intended use population treated with MagDI System. This study will be conducted through an observational patient registry and compare registry data to the premarket MagDI System clinical study data (GTM-001) and scientific literature. This post-market Registry Study was also a condition of the MagDI System FDA 510(k) clearances K242086 and K243359.

Eligibility Criteria:
Inclusion Criteria:

1. \>21 years of age, at the time of informed consent.
2. Body Mass Index (BMI) between 30-50 kg/m2.
3. Indicated for a side-to-side duodeno-ileal anastomosis and is treated with the MagDI System at a U.S. registry center.
4. Participant has been informed of the nature of the registry.

Exclusion Criteria:

1. Participant does not provide informed consent to be enrolled and followed in the registry.
An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma

An open label, single-arm clinical study evaluating the safety and efficacy of ICI201 infusion in relapsed/refractory multiple myeloma


Eligibility Criteria:
Inclusion Criteria:

* 1. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma. 2. Subjects must have previously received at least 3 anti-myeloma regimens. Subjects must have documented disease progression (according to IMWG criteria) during or within 12 months of completing their last anti-myeloma regimen prior to study entry; and prior regimens must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD). 3. Measurable disease as defined by the protocol 4. ECOG score is 0 or 1. 5. Expected survival time ≥12 weeks. 6. GPRC5D positive expression in bone marrow plasma cells

Exclusion Criteria:

* 1. Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants drugs. 2. Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection. 3. Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses \< 10mg/ day). 4. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg). 5. Patients who have recieved GPRC5D-targeted therapy
The Effect of Nursing Care Based on Kolcaba's Comfort Theory on of Intensive Care Patients

Nurses aim to care for people who can no longer carry out their life activities and needs, and to ensure that they can continue to live their lives as well as possible. The aim is to improve the quality of life by making life more comfortable through care. Comfort in care means solving the patient's problems, being peaceful and content, and relieving pain/suffering. Kolcaba explained that comfort theory can be used as a guide to meet the comfort needs of individuals in the care process. The theory explains the concept of comfort as relaxation, refreshment and the ability to overcome problems (superiority). According to this theory, the nurse identifies the comfort needs of the patient and family and plans and implements interventions to meet these needs. There are no studies in the literature that have investigated the effect of nursing care based on Kolcaba's comfort theory on the comfort, satisfaction and sleep quality of ICU patients. The aim of this study is to determine the effect of nursing care based on Kolcaba's Comfort Theory on the comfort, satisfaction and sleep quality of ICU patients.

The study is a randomised controlled experimental study to determine the effect of nursing care based on Kolcaba's comfort theory on comfort, care satisfaction and sleep quality of intensive care patients. Power analysis was used to determine the sample size of the study. As a result of the power analysis, it was determined that a total of 44 participants, 22 participants in each group, should be reached to achieve 80% power with an effect size of 0.87, a margin of error of 0.05% and a confidence interval of 0.95%. To increase the reliability of the study, a total of 80 participants, 40 in the intervention group and 40 in the control group, should be included in the study, taking into account data loss. In this study, the control group will receive standard care and the intervention group will receive care based on Kolcaba's comfort theory. Data will be collected using the General Comfort Scale, the Newcastle Satisfaction Scale, the Richard Campbell Sleep Scale and the Comfort Behaviours Checklist.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research,
* 18 years of age or older,
* Being open to communication,
* Clear state of consciousness
* Staying in the intensive care unit for at least 24 hours

Exclusion Criteria:

* The patient is taking sedative medication
* Being diagnosed with a sleep disorder,
* The use of sleeping pills,
* Loss of hearing and/or vision
* Use of a hearing aid
* Dependence on mechanical ventilator
* illiteracy
A Study of Second-line Treatment With Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma

The purpose of this study is to explore the efficacy and safety of second-line treatment of apatinib in advanced intrahepatic cholangiocarcinoma patients and evaluate drug safety, progression free and overall survival. The primary endpoint of this study is objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).


Eligibility Criteria:
Inclusion Criteria:

* Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;
* Have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment;
* The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment;
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
* Eastern Cooperative Oncology Group performance score (ECOG): 0-2;
* Life expectancy of at least 12 weeks;
* Subjects who understand and voluntarily signed a written informed consent form.

Exclusion Criteria:

* Previous locoregional therapy within 4 weeks prior to enrollment.
* Diagnosed with hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
* History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma.
* Prepared for liver transplantation.
* Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction).
* A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence.
* Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment.
* Patients with central nervous system metastases or brain metastasis
* Previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia.
* Pregnant or lactating women.
* Patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment.
Clinical Effect of Lactobacillus Reuteri in Treatment of Gingivitis

The aim of this randomized placebo- controlled clinical trials is to evaluate the effects of Lactobacillus reuteri containing probiotic lozenges as an adjunct to scaling and root planning (SRP). Material and methods: Thirty six gingivitis patients will be recruited and monitored clinically at baseline, 3 and 6 month after therapy. All patients will receive scaling and periodontal treatment and randomly will be assigned over an experimental (SRP + probiotic, N=18) or control (SRP+ placebo, n=18) group. The lozenges will be used once per day during 3 month.

Gingivitis is the most prevalent worldwide periodontal disease, is characterized by inflammation of the tissues surrounding the tooth without causing periodontal attachment loss. Preventive and / or therapeutic measures to facilitate or improve their control are therefore very important, much more if you consider that gingivitis and periodontitis are considered part of an ongoing inflammatory process. Treatment of gingivitis, like that of all periodontal diseases has been based on the implementation of control measures personal and professional plaque. Notwithstanding the foregoing, it has been reported that although mechanical therapy achieved significantly decrease the periodontopathogens, this may be only temporary since bacteria can recolonize the treated niches in the oral cavity. In this context, it has emerged as a new treatment strategy complementary use of probiotics such as Lactobacillus reuteri, which possess anti-bacterial and anti-inflammatory properties. Generally speaking, probiotics would promote health by competitive exclusion of some or positive pathogenic bacteria. Objective: To evaluate the effect of the administration of Lactobacillus reuteri as an adjunct to conventional periodontal therapy in adolescent and young adult patients with gingivitis. Methodology: A randomized double-blind clinical trial to evaluate the effect of probiotic lozenges Lactobacillus rhamnosus as an adjunct to conventional periodontal treatment of patients with gingivitis will be performed. Expected Results: Statistically significant decrease in bleeding and gingival index in the experimental group compared with the control.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Gingivitis
* Gingival index \> 1.5 (\> 10 % of sites examined)
* Bleeding index \> 10 % sites surveyed
* Probing Depth \< 4 mm
* Systemically healthy (except for the presence of gingivitis)
* Patients who have not received periodontal treatment before the test and no intake of medicines such antibiotic and/ or anti-inflammatory in the last 3 months prior to the start of the study

Exclusion Criteria:

* Patient who develop systemic disease during the study
* Patient who have to ingest antibiotic/ or anti-inflammatories during the study
* If you are a woman becomes pregnant during the study
The Effective of Potassium Sodium Hydrogen Citrate in Treating Uric Acid Stones Using Gut Microbiota and Metabolomics.

The goal of this observational study is to investigate the alterations in gut microbiota and metabolites among patients with uric acid stones following the administration of potassium sodium hydrogen citrate. The main question it aims to predict the potential metabolic mechanism and therapeutic target of potassium sodium hydrogen citrate in treating uric acid stones through analysis of gut microbiota and metabolomics. The participants were required to undergo a 3-month drug intervention, providing blood, urine, and stool samples before and after treatment. No additional interventions were implemented for the subjects.

The objectives of this study were to investigate the association between the presence of bacterial genera and short-chain fatty acids (SCFAs) in stool, as well as biochemical elements in blood and urine, among patients with uric acid nephrolithiasis. The sensitivity difference of potassium sodium hydrogen citrate in treating uric acid kidney stones was examined through gut microbiota analysis and metabolomics to predict potential metabolic mechanisms and sensitive targets for treatment. Blood biochemistry, 24-hour urine composition analysis, and other indicators were collected from the subjects. Fecal samples were obtained for 16S ribosomal RNA sequencing to analyze the characteristics of gut microbiota in relation to blood and urine biochemical metabolism indicators. Subjects received treatment with potassium sodium hydrogen citrate granules for a duration of 3 months. Blood and urine biochemical indexes, fecal samples, 16S ribosomal RNA sequencing data, and short-chain fatty acid levels in fecal samples were collected before and after treatment. The care of the enrolled patients will not be subject to any intervention.

Eligibility Criteria:
Inclusion Criteria:

All stone patients were diagnosed using urologic ultrasonography, kidney-ureter-bladder (KUB) X-ray, or abdominal computed tomography (CT). Stone samples were obtained through ureteroscopic lithotripsy (URSL), percutaneous nephrolithotomy (PCNL), or extracorporeal shock wave lithotripsy (ESWL). Stones were analyzed using an automated infrared spectroscopy system, LIIR-20 (Lanmode Scientific Instrument Co., Ltd., Tianjin, China), and the main components were determined based on the most abundant substances listed in the report, which were classified as pure or mixed uric acid stones (anhydrous uric acid content \>50%).

Exclusion Criteria:

Patients with malignancy, chronic liver insufficiency, a history of statin use, and thyroid or parathyroid disease were excluded from the study. Similarly, individuals with a history of urolithiasis or dyslipidemia as well as those who had used statins were excluded from the control group. Participants were also excluded if they had taken antibiotics or immune suppressants within one month prior to fecal sampling, or had a history of chronic diarrhea or constipation, chronic enteritis, irritable bowel syndrome, gastrointestinal tumors or intestinal surgery.
SupportBP 2.0:Behavioral Science and Enrollment in Remote Monitoring for Hypertension Management

A 3-arm randomized pilot trial aimed at comparing the effectiveness of different approaches to recruiting patients to participate in a 6-month remote monitoring program for the management of hypertension (HTN).

The investigators will utilize the Way to Health (WTH) platform to develop and evaluate a new remote monitoring enrollment model that is integrated with routine clinical care at Penn Family Care (PFC), an academic family medicine practice in West Philadelphia. Among patients with poorly controlled HTN the investigators will:

1. Compare the effect of sending eligible patients a blood pressure cuff with the mailed invitation letter and opt-out framing versus the more conventional method of phone calls following mailed letters.
2. Evaluate the feasibility and effectiveness of a remote monitoring program with individualized stepped escalation for hypertension management.

Eligibility Criteria:
Inclusion Criteria:

1. Between 18 and 75 years old with HTN (ICD-10 code I10)
2. Has had at least one office visit at Penn Family Care (PFC) within the past 12 months (at time of chart review), with the last visit having a BP reading exceeding HTN guidelines (150/90 if \>60 or, 140/90 if ages 21-59 yrs or has CKD or diabetes).
3. Must have a cellular phone with texting capabilities
4. Must be prescribed at least one medication for hypertension

Exclusion Criteria:

1. Has metastatic (Stage IV) cancer
2. Has end stage renal disease
3. Has congestive heart failure
4. Has dementia
5. BMI \>= 50
6. Is Non-English speaking requiring a translator
Efficacy of Roflumilast in Prevention of Peripheral Neuropathy

There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. At the preclinical level, roflumilast potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated.


Eligibility Criteria:
Inclusion Criteria:

1. Breast cancer patients who will receive paclitaxel post-anthracycline therapy.
2. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
3. Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin \<1.5 mg/dl), renal function (creatinine \< 1.5 mg/dl).

Exclusion Criteria:

1. Patients with signs and symptoms of clinical neuropathy at baseline.
2. Patients with diabetes mellitus or alcoholic disease.
3. Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
Safety and Efficacy of SR121463B in Patients With Syndrome of Inappropriate Antidiuretic Hormone Secretion

To determine the long-term safety and tolerability of SR121463B in patients with syndrome of inappropriate antidiuretic secretion (SIADH). To assess the long-term efficacy of SR121463B in maintaining normal levels of serum sodium in patients with SIADH.

Long term safety is evaluated further in an open label extension study with flexible doses of satavaptan.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged 18 years and higher.
* SIADH (the diagnosis of SIADH is based on several criteria including true serum hypoosmolality, inappropriate urinary osmolality, clinical euvolemia, elevated urinary sodium excretion while on normal salt and water intake, and normal renal, adrenal, and thyroid functions: drug induced SIADH will be limited to carbamazepine or derivatives and antidepressants in patients in whom these drugs cannot be discontinued or easily replaced by other drugs)
* Serum sodium between 115 and 132 mmol/L (at least two consecutive serum sodium levels of at least 24 hours apart, from Day -6 to Day -1); for sodium levels between 125 and 132 mmol/L, the spontaneous serum sodium increase between the two assessments on Day -1 should be \< 4 mmol/L
* Urinary osmolality \>200mOsm/kg H2O
* Urinary sodium \> 30 mmol/L

Exclusion Criteria:

* Patients with acute postoperative SIADH
* Presence of dilutional hyponatremia in hypervolemic states such as congestive heart failure and liver disease with ascites
* Presence of signs of hypovolemia (e.g., orthostatic hypotension, increased serum urea nitrogen, increased serum albumin, increased hematocrit, ...)
* Administration of other V2 receptor antagonists or demeclocycline or lithium within one month, thiazides diuretics or spironolactone within 15 days, and urea or loop diuretics within two days prior to study drug administration
* Patients with known treated or untreated adrenal deficiency
* Presence of untreated hypothyroidism
* Presence of uncontrolled diabetes with fasting glycemia \> 200 mg/dL (\> 11.09 mmol/L)
* Presence of clinical and/or electrocardiographical signs of acute myocardial infarction or acute ischemia, or any other clinically significant abnormality according to the Investigator on a 12 lead ECG recording
* Administration of inducers of CYP3A4 (phenytoin, rifampin, Saint John's Wort) or potent and moderate inhibitor so CYP3A4within two weeks prior to study drug administration
* Inadequate hematological, renal and hepatic functions; hemoglobin (Hb) \< 9 g/dL, neutrophils \< 1,500/mm3, platelets \<100,00/mm3, serum creatine \>175 µmol/L (or clearance of creatine \<30mL/min for where Ethics Committees require this parameter), ALT and /or AST \>2x upper limit of normal
* QTcB \> 500 ms
* Serum potassium \> 5 mmol/L
The Relationship Between Pet Therapy and "Well-being" in Geriatric Rehabilitation In-patients

In -patients in a geriatric rehabilitation unit, will participate in structured therapy with guinea-pigs on the assumption that the therapy will reduce anxiety and improve the outcome of their rehabilitation.

Measurement of anxiety before and after pet therapy using standardized questionaire.

Eligibility Criteria:
Inclusion Criteria:

willingness to touch the pets,-

Exclusion Criteria:

blindness,deafness,aphasia, lack of knowledge of hebrew language,allergy or phobia to animals.MMSE less than 21,duration of admission lessthan two weeks.-
Phase 2 Study of Telintra® in Deletion 5q Myelodysplastic Syndrome

Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome (MDS).

Study TLK199.2107 is a multicenter, single arm, open-label Phase 2 study of oral ezatiostat (Telintra®) in patients with lenalidomide (Revlimid®) refractory or resistant, red blood cell (RBC) transfusion-dependent, Low to Intermediate-1 IPSS risk, del5q Myelodysplastic Syndrome (MDS). Independence from red blood cell transfusions, improvement in the levels of red blood cells, white blood cells, and platelets, and the response of the bone marrow were evaluated. Patients received a starting dose of 2000 mg total daily dose in divided doses (1000 mg orally twice daily for three weeks (21 days) on therapy followed by a one-week (7 days) off therapy rest period in four-week (28 days) treatment cycles. Patients continued treatment until documentation of lack of MDS response, MDS progression, unacceptable toxicity, or patient withdrawal from the study.

Eligibility Criteria:
Inclusion Criteria:

* Primary or de Novo MDS
* Low or Intermediate-1 IPSS risk MDS
* Deletion of the 5q chromosome \[del(5q) MDS\]
* Refractory or resistant to lenalidomide (Revlimid)
* ECOG performance score of 0 or 1
* Documentation of significant anemia with or without additional cytopenia
* Adequate kidney and liver function
* Patients must have discontinued hematopoietic growth factors at least 3 weeks prior to study entry

Exclusion Criteria:

* Prior allogenic bone marrow transplant for MDS
* Known sensitivity to ezatiostat (injection or oral tablets)
* Prior treatment with hypomethylating agent (HMA) (e.g., azacitadine, decitabine)
* History of MDS IPSS risk score of greater than 1.0
* Pregnant or lactating women
* Any severe concurrent disease, infection or comorbidity that, in the judgement of the investigator, would make the patient inappropriate for study entry
* Oral steroids greater than 10 mg per day. Exceptions: those prescribed for other conditions (such as new adrenal failure, asthma, arthritis) or brief steroid use (such as tapered dosing for an acute non-MDS condition)
* History of hepatitis B or C, or HIV