cyrilzakka/clinical-trials huggingface dataset:
Influence of the Use of the Diabetic Drug Metformin on the Overall Survival and Treatment-related Toxicity in Advanced Stage Non-small Cell Lung Cancer Patients.

There are preliminary data suggesting that patients suffering from non-insulin-dependent diabetes mellitus, treated with metformin, have improved local tumor control. A reduction in the tumor's hypoxia may be responsible for this phenomenon.

Therefore, the aim of this study is to test the hypothesis in three cohorts of patients suffering from advanced stage non-small cell lung cancer and all undergoing concurrent radiochemotherapy: 1. Patients with diabetes mellitus treated with metformin only; 2. Patients with insulin-dependent diabetes mellitus not treated with metformin; 3. The remaining patients serving as controls. Furthermore, tumor and treatment-related parameters will be correlated with overall survival and morbidity.

There are preliminary clinical and preclinical data suggesting that patients suffering from non-insulin-dependent diabetes mellitus, treated with metformin, have improved local tumor control. The reduction in oxygen consumption of tumor cells and thus a relative reduction in the tumor's hypoxia may be responsible for this.

Non-small cell lung cancer is the most frequent solid tumor in many Western countries and the number one cause of cancer-related death. Even though the introduction of concurrent chemoradiotherapy has improved local tumor control and thus overall survival, 5-year overall survival is still as low as 14%. Furthermore, many patients are not eligible to undergo concurrent treatment thus reducing their chances to defeat this disease. Additionally, concurrent chemoradiotherapy is associated with increased toxicity compared to sequential treatment. Therefore, alternative additives improving the effect of radiotherapy without increasing toxicity to an unbearable level are searched for. One possible pharmaceutical is metformin; many patients have been using it in the past without evident increased toxicity, it is cheap, and widely available.

Thus, the aim of this study is to test the hypothesis that metformin increases overall survival without enhancing treatment-related toxicity. For this means, in three cohorts of patients suffering from advanced stage non-small cell lung cancer and all undergoing concurrent radiochemotherapy: 1. Patients with diabetes mellitus treated with metformin only; 2. Patients with insulin-dependent diabetes mellitus not treated with metformin; 3. The remaining patients serving as controls. Using Kaplan-Meier statistics as well as uni- and multivariate analysis, the overall survival and toxicity of these cohorts will be compared. Other potentially confounding factors will be tested as secondary endpoints.

Eligibility Criteria:
Inclusion Criteria:

Advanced non-small cell lung cancer patients undergoing primary concurrent radiochemotherapy; patients treated with metformin or insulin will be analyzed as separate cohorts.
Individualized Nutrition Therapy for Preventing or Delaying Onset of Type-2 Diabetes

The overall aim of this feasibility study is to conduct a randomized, controlled intervention providing adults with prediabetes either an individualized nutrition therapy (INT) intervention that contains individualized dietary goal-setting components, the goal being to improve blood glucose, reduce CVD risk factors, and therefore postpone the onset of diabetes and related cardiovascular disease, or standard-of-care generalized dietary recommendation (SOC). The hypothesis is that the INT arm will experience greater benefits in some or all of the following primary outcome variables: improvement in postprandial blood glucose, oral glucose tolerance test, fasting insulin, and calculated insulin sensitivity (HOMA) in individuals with prediabetes. Secondary outcome variables are improved markers of inflammation, antioxidant status, blood lipids, blood pressure, and endothelial function.


Eligibility Criteria:
Inclusion Criteria:

* Ages 45-65 years
* Any race or ethnicity
* Those who have or may have pre-diabetes (will be screened to confirm)
* HbA1c level between 5.7%-6.4% (will be screened to confirm)
* BMI between 25 and 39.9 kg/m2
* Taking stable doses of antihypertensive and/or cholesterol-lowering medications for 3 months or more prior to being enrolled in the study

Exclusion Criteria:

* Pregnant or lactating
* Individuals outside of the HbA1c and BMI inclusion ranges
* Those with active cancer, thyroid, kidney, liver, and pancreatic diseases
* Heavy cigarette smokers (25 cigarettes per day or more)
* Heavy drinkers (\>12 alcoholic drinks per week on average)
* Taking more than one hypoglycemic agent (blood sugar lowering medications)
* Having major dietary restrictions
* Participating in any weight loss or dietary program/taking prescribed appetite suppressants
* Participating in another investigational study at the same time as this study
* Anyone who refuses to follow dietary recommendations
* Anyone who refuses to wear the continuous glucose monitoring device as instructed
* Anyone who will not fill out their food dairy and automated self-administered dietary assessment tool
Distress Associated with Coronavirus Disease 2019 and Telehealth on Supportive Care Patients with Advanced Cancer

This study assesses the level of distress felt by cancer patients due to the coronavirus disease 2019 (COVID-19) pandemic. Researchers also want to learn if patients prefer to receive supportive care (palliative care) in person or through telemedicine (visits by phone or video call, such as Zoom). Information from this study may help doctors better understand how COVID-19 has affected patients with advanced cancer, patients' perceptions of telehealth, and may help clinicians tailor care to patients' needs during the pandemic.

PRIMARY OBJECTIVES:

I. Assess advanced cancer patients' level of distress due to the COVID-19 pandemic.

II. Assess patients' overall preference towards palliative telemedicine vs in person visits during the COVID-19 pandemic.

SECONDARY OBJECTIVES:

I. Assess associations between patient characteristics and perceptions of overall distress due to the COVID-19 pandemic.

II. Assess associations between patient characteristics and their attitudes and beliefs towards palliative telemedicine during the COVID-19 pandemic.

III. Compare the attitudes and beliefs towards palliative telemedicine between patients who completed visits via video vs telephone.

OUTLINE:

Patients complete survey over 20 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease
* Age 18 or greater
* Patient presenting for at least two follow-up visits with Supportive Care visit since the COVID19 pandemic (after March 23, 2020), consisting of either in-person, or virtual
* For patients who have had two consecutive video visits, or consecutive telephone visits with supportive care, they will be asked to complete additional questions regarding telehealth visits

Exclusion Criteria:

* Memorial Delirium Assessment Scale (MDAS) of 7 or more or if determined to be of impaired cognition by the clinician at the time of clinic visit as documented in the visit either by history or exam. Providers routinely note screening for mental status with routine administration of the MDAS or history of altered cognition or noted on exam
* Non-English-speaking participants
* Unwilling or unable to provide informed consent
Effects of Novel Breathing Behavior Modification Yoga Positioning Integrated Program on Weight Loss

This study is to evaluate the physical and cognitive effects of a 15 min per day novel breathing and mindfulness moving-meditation program on metabolism, cognition, and emotion health. It is thought that the breathing and movement program will increase basal metabolism, facilitate fat loss, and decrease depressive behaviors. Anthropometric, blood chemistries, and cognitive measures of depression, sleep, and hunger will be measured over a two-month interventional program.

Subjects will be randomized into two groups, an active group and control group. For the first 30 days, the active group will follow the movement/breath program and the controls will be instructed not to change their lifestyle (no change in diet, and no change in exercise / physical activities). The technicians taking measurements will be blinded as to which participants are actives vs controls. The following 30 days' intervention will consist of continuing the Phase I interventions combined with implementing the behavior change strategies on 2 to 3 habit changes self-selected from a list of 30 top "bad habits" that contribute to weight gain and undermine one's ability to lose weight with the control group again not changing any lifestyle activities. Measurements: Measurements will be taken at the start (baseline), 10 days, 30 days, and 60 days of intervention with the measurement days scheduled to evaluate people completing 10 full days of the program, 30 full days, and 60 full days respectively. Measurements taken at each interval to include weight, body composition (lean mass \& fat percentages), anthropometric measurements (umbilicus, hips, right thigh, right upper arm), pO2, resting heart rate, HRV, blood pressure, pulmonary health (i.e., O2 max, spirometry), hunger, sleep, and depression rating (by self-assessment survey scale). Serum chemistry for basic metabolic panel, inflammatory markers, and lipids, hematology for oxygen carrying capacity and gross immune response, Human Growth Factor production via ELISA quantification, imaging ultrasound to measure subcutaneous fat thickness at the areas of girth measurements, DEXA for overall and targeted areas body composition, and resting metabolic rate via oxygen plethysmograph.

Eligibility Criteria:
Inclusion Criteria

* Age 18-70 years
* Body Mass Index at or above 27
* Stable weight past 3 months
* able to stand for 10 minutes
* Able to lift arms overhead

Exclusion Criteria:

* Chronic Obstructive Pulmonary Disease
* acute respiratory distress
* supplemental oxygen use
* inability to stand, flex trunk, or move arms overhead
* Pacemaker implant
* Taking beta blocking medications.
Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia

This study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of schizophrenia in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.


Eligibility Criteria:
Inclusion Criteria:

* Are male or female patients, 13 to 17 years of age
* Patients must have a diagnosis of schizophrenia per DSM-IV-TR.
* Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment.
* Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
* Patients must be capable of swallowing study medication whole (without crushing, dissolving, etc.)

Exclusion Criteria:

* Female patients who are either pregnant or nursing.
* Patients with acute or unstable medical conditions.
* Patients who have been judged clinically to be at serious suicidal risks.
* Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
* Patients who currently have delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder or major depressive disorder.
"Validation and Reability of the Munich Shoulder Questionnaire Into Turkish Patients"

The purpose of this study was to translate and culturally adapt the MSQ to Turkish language and test the validity and reliability of Turkish version of MSQ in shoulder dysfunction patients. And also, the ultimate goal was to facilitate international researches in shoulder problems as well as to serve the physicians for their clinical practice.

Munich Shoulder Questionnaire (MSQ) is an innovative tool for self-assessment of shoulder function. It was especially designed for an effective follow-up of shoulder patients which were also allowing for a quantitative assessment of the Constant, Shoulder Pain and Disability Index (SPADI) and DASH score consisting of a 30-items questionnaire. It based on subjective and objective parameters of shoulder function.

Standart questionnaire enable to follow patients on a close and regular base with manageable effort for both the disability and the patients.an optimal instrument for outcome measurement of shoulder problems should meet the following requirments: a) the instrument should be a self-assmment patient reporting tool, b) the questions must be easily comprensible, c) filling in should be finished less than 30 minutes, d) the results should provide calculation of several well established scoring system. MSQ can be completed at home and typical functional abilities about evaluation are explained with pictures so these can make it easy. As a result, we choose to translate the MSQ into Turkish as it is less costly, practical and time consuming than developing a new tool. In addition, objective (normal joint movement and muscle strength) and subjective (pain, daily life activity, sport and leisure time activities) parameters in a single form to create the advantage in terms of ease of use and time. With these properties, MSQ may be preferred during follow-up of the results of conservative and / or surgical treatment.

Eligibility Criteria:
Inclusion Criteria:

* being between 18-65 years old,
* having unilateral or bilateral shoulder dysfunction,
* ability to read and complete the self-assessment questionnaires

Exclusion Criteria:

* have neurological, psychological and cardiovasculer diseases or injuries
Serum Lipid Levels and Lp-PLA2 in Chronic Periodontitis

To assess the association between periodontal parameters, serum lipid profile and Lp-PLA2 level in systemically healthy Chronic Periodontitis subjects and healthy controls.

Seventy five participants were divided into 3 groups. The groups consisted of GROUP I- generalized severe chronic periodontitis, GROUP II- generalized moderate chronic periodontitis and GROUP III- systemically and periodontally healthy volunteers who served as control. The selected patients were then evaluated for periodontal parameters, lipid profile and Lp-PLA2.

Eligibility Criteria:
Inclusion Criteria:

Group I:

1. Subjects with age ≥ 35 years.
2. Presence of at least 24 teeth, with Clinical attachment loss (CAL) ≥ 5mm in more than 30% of sites.

Group II:

1. Subjects with age ≥ 35 years.
2. Presence of at least 24 teeth, with Clinical attachment loss (CAL) between 3-4 mm in more than 30% of sites.

Group III:

1. Subjects with age ≥ 35 years.
2. Healthy and intact periodontium

Exclusion Criteria:

1. Presence of any systemic disease or conditions that could affect periodontal tissues.
2. History of periodontal treatment in past 6 months.
3. Smoking and alcoholism
4. Anomalies of blood and immune system
5. Systemic medication or antibiotic treatment for the previous 6 months.
6. Pregnant females.
Manual Therapy in Parkinson's Disease

An experimental study will be carried out to examine how a manual therapy protocol can influence a series of parameters related to motor and non-motor symptoms in patients who have Parkinson's disease / Parkinsonism.

To do this, an intervention will be carried out that will last a minimum of 6 weeks. In addition to their ongoing treatment, the study subjects will receive a maximum of 2 sessions of manual therapy each week. They will undergo a series of measurements both before and after the intervention related to gait, balance, non-motor symptoms, and some more specific parameters of gait.

The study's main objective is to obtain information about possible treatment models based on manual therapy for Parkinson's disease. It is also hoped to compile a series of results that will lead to conclusions and benefit the development of physiotherapy for this disease. It is also hoped that this will help those affected so that the treatment is as comprehensive as possible and that the physiotherapist can use as many tools as are available to them to address the pathology.


Eligibility Criteria:
Inclusion Criteria:

* People aged between 40 and 75 who voluntarily agree to take part in this study

Exclusion Criteria:

* People with Dementia and established cognitive impairment with scores on the Montreal Cognitive Assessment Test (MoCA) of less than 25
Weight Cycle Post Intervention

The aim of this follow-up (FU) study is to examine trajectory of body weight impacted by self-reported diet patterns and physical activities in 6 months at 3 monthly intervals from treatment cessation among patients who completed a pharmacotherapy trial. In addition, patient self-reported diet patterns and physical activities at respective time points will be described.

This is a real-world prospective observational study with primary data collection. All participants with a background be recommended to adopt lifestyle intervention as chronic weight management in China clinical practice. This FU study will enroll patients who completed SURMOUNT-CN trials, with planed study duration of 6 months. No investigational medicine is applied in this prospective follow-up study.

Patients are requested to report body weight, waist circumferences, blood pressure, diet, physical activities, and laboratory results if available, at 3 monthly intervals during the 6-month follow-up period. Patients are also asked if they receive any Anti-Obesity medication (AOM) or participate in any interventional clinical trials indicated for weight management during study period. Summary statistics will be respectively applied to examine changes from trial baseline (time at trial randomization, week 0) and study baseline (time at 52 weeks from trial randomization, week 52) to each scheduled follow-up (at week 65 and week 78) by study arms in SURMOUNT-CN trial.

Eligibility Criteria:
Inclusion Criteria:

* All patients who completed SURMOUNT-CN trial are target patients. Those who consent to this follow-up study are study participants.

Exclusion Criteria:

* Those in the SURMOUNT-CN trial who denied to participant.
Glivec in Ph Positive Lymphoblastic Leukemia

% positive Ph LLA with RC alter the Glivec and induction chemotherapy treatment

Pilot phase II clinical trial, prospective, multicentric and opened

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis LLA Ph+ (BCR/ABL) patients ≤ 65 years old
* Fertile age women must do a pregnancy test in the 7 days previous at the beginning of clinical trial medication
* Performance status 0-2 (Appendix B); Is allowed performance status \> 2 because of LLA
* Patients without organ alteration: hepatic function: global bilirubin, AST, ALT, gamma-GT and alkaline phosphatase less than 2 times LSN; renal function: Creatinine \< 1,5 mg/dl o Clearance creatinine \> 60 ml/min; anormal renal function caused by LLA ; normal heart function (Appendix B): FEV \> 50%; No Chronic respiratory illness. If the anormal values are secondary of the experimental illness the investigator can decide himself if the patient can be included at the clinical trial.
* Negative HIV serology
* Written, oral or with witness informed consent. In patients \< 18 years old must be signed written and legal representative informed consent.
* No experimental chemotherapy or other experimental treatment. Allowed to begin induction chemotherapy from the diagnosis to confirm Ph. No major surgical process in the previous 14 days of the treatment Start.

Exclusion Criteria:

* Other LLA variability
* Previous history of coronary valvular, hypertensive cardiopathy illness
* Chronic hepatic illness
* Chronic respiratory insufficiency
* Renal insufficiency not caused by LLA
* Severe neurological problems not caused by LLA
* Severe affection of the performance status (grade 3-4 OMS gradation) not caused by LLA
* Pregnancy and women
* Blastic crisis LMC
Effect of Acetazolamide on Right Ventricular Function During Exercise in Patients With Respiratory Disease at Altitude

This trial will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function during exercise at acute altitude exposure in patients with COPD.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on right ventricular function during exercise in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo) will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

Right ventricular function will be assessed during graded cycling on an ergometer by transthoracic echocardiography.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients, age 18-75 yrs.
* COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.

Exclusion Criteria:

* COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC \<0.7, FEV1 \<40% predicted, oxygen saturation on room air \<92% at 750 m).
* Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
* Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day)
* Known renal failure or allergy to acetazolamide and other sulfonamides
A Study for Patients With Non-Hodgkin's Lymphomas

In this study, all patients will get investigational drug. There will be no comparator drug. This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes:

* T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL)
* Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2) and marginal zone lymphoma
* Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Have measurable lesions
* Have recovered from prior chemotherapies
* Have an estimated life expectancy of at least 12 weeks
* Hepatic: total bilirubin less than or equal to 1.5 XULN; ATL/AST less than or equal to 2.0 x ULN (less than 5x if liver metastases are present)
* Renal: serum creatinine less than or equal to 1.5XULN
* Adequate bone marrow reserve: platelets greater than or equal to 75 x 109 /Liter (L) Criteria:
* Have a second primary malignancy (except adequately treated nonmelanomatous skin cancer, or other cancer that is considered cured by surgical resection or radiation).
* Anti-lymphoma therapy within the past 3 weeks
* Unable to swallow tablets
* Unable to discontinue use of carbamazepine, phenobarbital and phenytoin at least 14 days prior to study enrollment
Gemcitabine or Gemcitabine Plus Docetaxel After Cisplatin, Etoposide and Radiation in Non Small Cell Lung Cancer (NSCLC)

To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.


Eligibility Criteria:
Inclusion Criteria:

* histologic or cytologic proof of single primary non-small cell lung cancer
* No prior chemotherapy or radiation therapy
* no prior malignancy

Exclusion Criteria:

* pregnancy or breastfeeding
* serious concomitant systemic disorder
* unintentional weight loss greater than 10%