cyrilzakka/clinical-trials huggingface dataset:
Effects of Pea Proteins With Different Degrees of Processing on Postprandial Metabolism in Healthy Adults

The aim of this study is to investigate the postprandial metabolic responses to plant-based protein ingredients of different degrees of processing (pea protein concentrate, isolate, and extrudate) and in comparison to whey protein in healthy adults. Therefore, young healthy subjects consume 4 test meals with 25 g of protein from pea protein concentrate, pea protein isolate, pea protein extrudate or whey protein in a randomized order. In a postprandial period of 6 hours, parameters of protein and glucose metabolism (i.a. plasma amino acids), gastric emptying and hunger/satiety are analysed. It is assumed that the plasma amino acid profile after plant protein ingestion differs depending on processing level of the protein ingredients and in comparison to whey protein.

In a randomized crossover-design, 20 healthy women and men consume 4 test meals containing either 25 g of protein from plant protein ingredients (pea protein concentrate, isolate, or extrudate) or whey protein together with 1 g paracetamol, which is used as a marker for gastric emptying.

During a postprandial period of 6 hours parameters of protein metabolism (e.g. amino acids in plasma and urine), glucose metabolism (plasma glucose, serum insulin) and gastric emptying rate (based on plasma paracetamol) are analysed. Furthermore, subjective hunger/satiety and acceptance of the meals are assed using visual analogue scales. Each intervention arm will be separated by a washout period of at least 7 days.

Eligibility Criteria:
Inclusion Criteria:

* non-smoking
* metabolically healthy
* normal weight (BMI: 18,5 - 24,9 kg/m2)
* written informed consent

Exclusion Criteria:

* pregnancy, lactation
* hypo- or hypertension
* underweight or overweight/obesity
* food intolerances and allergies (especially milk protein, pea, celery)
* malabsorption syndromes
* gastrointestinal diseases
* thyroid diseases
* diabetes mellitus type 1 and type 2
* impaired kidney or liver function
* anaemia
* blood coagulation disorders
* irregular menstrual cycle
* endometriosis, severe menstrual problems
* hormonal contraception
* regular use of medications (especially habitual use of paracetamol or medications that may interact with paracetamol)
* hypersensitivity to paracetamol
* body weight below 50 kg
* alcohol abuse
* glucose-6-phosphate dehydrogenase deficiency
* Gilbert's syndrome
* vegan diet
* eating disorders (especially anorexia nervosa, bulimia nervosa)
* smoking
* participation in another study
Innovative Interventions for Smoking Cessation

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.

The following primary hypothesis will be tested:

Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.

Other hypotheses include:

1. Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;
2. Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and
3. Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.

Cigarette smokers will be randomized to:

1. VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;
2. Nicotine patch for 6 weeks; or
3. VLNC cigarettes alone.

Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.

Eligibility Criteria:
Inclusion Criteria:

* a) Smoking at least 10 cigarettes daily for the past year;
* b) In good physical health;
* c) No contraindications for medicinal nicotine; and
* d) Stable, good mental health.

Exclusion Criteria:

* a) Subjects must not be using other tobacco or nicotine products.
* b) Female subjects cannot be pregnant or nursing and must be using appropriate birth control.
Art Therapy as Treatment for Fear of Childbirth

Earlier research has shown that pregnant women with a pronounced fear of childbirth have a significantly increased risk for birth complications and subsequent psychological trauma. In Sweden and also internationally, women in fear of childbirth are treated in many differing ways. Evidence for best care for these women is lacking. The Art Therapy method is a creative, psycho-therapeutic form of treatment which has been used for several decades within psychiatry. It has recently been seen that the Art Therapy method has positive effects during treatment for crisis reactions.

Recruitment has recently been initiated for a randomized controlled study of Art Therapy for the treatment of fear of childbirth.

The hypothesis for the study is as follows:

H1 = treatment with Art Therapy and therapeutic conversations will result in a decrease in fear of childbirth when compared to treatment by therapeutic conversations only.

The instrument which is to be used for measurement of childbirth fear is the Wijma Delivery Expectancy Questionnaire (W-DEQ). This is a well validated instrument which was developed in Sweden. A power calculation has shown a need for 62 x 2 participants; a total of 124 women.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Pronounced fear of childbirth

Exclusion Criteria:

* Women with a current psychiatric diagnosis
* Women who do not understand Swedish
* Women with a current substance misuse
Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy and kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation or bone marrow transplantation in treating patients who have relapsed or recurrent germ cell cancer.

OBJECTIVES: I. Determine the response rate, overall survival, and disease-free survival of patients with refractory or relapsed germ cell carcinoma treated with high-dose induction chemotherapy comprising carboplatin and etoposide followed by autologous bone marrow or peripheral blood stem cell rescue.

OUTLINE: Autologous peripheral blood stem cells (PBSC) or bone marrow is harvested. Patients receive carboplatin IV continuously and etoposide IV over 1 hour on days -5 through -3. Autologous PBSC or bone marrow is reinfused on day 0.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Documented relapsed or refractory germ cell cancer of the following sites of origin: Testes Ovary Retroperitoneum Mediastinum Other sites Any stage of disease allowed Any histologic subtype allowed Seminoma only allowed if ineligible for radiotherapy Failed to achieve complete remission (CR) following at least 3 courses of a standard platinum-containing regimen or experienced clear relapse following CR obtained with such a regimen Absence of tumor markers in the presence of stable residual masses after initial treatment may be allowed (surgical biopsy should be performed; if medically safe, to confirm persistence of disease and rule out mature teratoma or fibrosis) Prior CNS involvement allowed in the absence of gross residual CNS tumor following definitive local therapy (surgery plus radiotherapy) No gross tumor involvement on bone marrow biopsy

PATIENT CHARACTERISTICS: Age: 15 to 60 Performance status: Karnofsky 80-100% Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL SGOT/SGPT less than 2 times normal Albumin greater than 3.0 mg/dL Renal: Creatinine less than 1.8 mg/dL Cardiovascular: LVEF at least 50% No other serious cardiac disease that would preclude transplantation Pulmonary: DLCO, FEV1, and FVC at least 50% predicted pO2 at least 70 mm Hg on room air Other: HIV negative No other concurrent serious psychiatric, neurologic, neoplastic, immunologic, or other medical problem that would preclude transplantation Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior chest irradiation Surgery: See Disease Characteristics
Improving Rates of Repeat Colorectal Cancer Screening

The United States Preventive Services Task Force (USPSTF) recommends colorectal cancer (CRC) screening using fecal occult blood testing (FOBT), sigmoidoscopy, or colonoscopy in adults, beginning at age 50 and continuing until age 75. However, rates of CRC screening remain inadequate. In 2006, only 60.8% of adults 50 or older reported recent CRC screening. Screening rates are even lower among Black and Hispanic populations and in areas with higher poverty rates. Annual or biennial FOBT testing over many years is essential for FOBT to be effective. Few studies have examined the rate of repeat FOBT testing; to the investigators knowledge, none have been conducted in populations with high prevalence of barriers to screening (e.g., low literacy, varied cultural norms, and transportation difficulties). The assumption that FOBT is an effective CRC screening strategy presumes it will be done at least biennially, and cost-effectiveness studies of CRC screening strategies have found that the results are sensitive to the rate of adherence. The investigators study will provide critical information for providers and policymakers as they consider optimal strategies to increase CRC screening among vulnerable populations.

Overall Study Goal: Improve colorectal cancer screening by increasing rates of repeat fecal occult blood testing (FOBT).

Aim 1: Test if a multifaceted intervention increases repeat FOBT testing adherence over a 30-month period

Hypothesis 1: Compared to usual care, the intervention will increase the proportion of patients who complete a repeat annual FOBT within 6 months of their due date.

Hypothesis 2: Compared to usual care, the intervention will increase the proportion of patients who complete 2 additional FOBTs over the 30-month intervention period.

Aim 2: Explore perceived barriers to screening among patients who received the intervention but did not complete repeat FOBT testing within 18 months

Aim 3: Assess the costs of the intervention and the costs per additional repeat screening compared to patients who received usual care.


Eligibility Criteria:
Inclusion Criteria:

* Fecal occult blood test (FOBT) completed in the past year
* Age 51-75
* Preferred language English or Spanish

Exclusion Criteria:

* Any of the following: (1) Colonoscopy within 10 years (2) Flexible sigmoidoscopy within 5 years or (3) A clinician order or referral for FOBT prior to the due date
* Documentation of medical conditions suggesting colorectal cancer (CRC) screening through FOBT may be inappropriate including: chronic diarrhea, inflammatory bowel disease, iron deficiency, previous colonic polyp, use of medications in the previous 1 month that elevate the risk of a false-positive FOBT
Pharmacokinetics of Anacetrapib (MK0859) in Subjects With Impaired Renal Function (MK-0859-038)

This study will evaluate the Area Under the Curve (AUC(0 to infinity)) of anacetrapib in subjects with impaired renal function and healthy matched control subjects.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects of reproductive potential test negative for pregnancy and agree to use two acceptable methods of birth control throughout the study
* Subject is in good health
* If Subject is a smoker, smoking is limited to no more than 10 cigarettes per day

Exclusion Criteria:

* Subject has a history of stroke, chronic seizures or major neurological disorder
* Subject has a history of cancer
* Subject is unable to refrain from or anticipates the use of any prescription or non-prescription medication during the study
* Subject consumes excessive amounts of alcohol or caffeine
* Subject has had major surgery, donated blood or participated in another investigational study within the past 4 weeks
* Subject is a nursing mother
* Subject has had a kidney removed or has a functioning renal transplant
Optimizing CNS DHA Delivery in Elderly Adults at Risk for Dementia

The purpose of this placebo-controlled trial is to compare the effects of 24-weeks supplementation with LPC-DHA and TAG-DHA on cerebrospinal fluid and blood DHA levels, as well as biomarkers of central neurodegenerative and neurotrophic activity, in elderly adults experiencing early signs of cognitive/memory decline. Extant evidence supports our overarching hypothesis that LPC-DHA supplementation will be more effective than TAG-DHA for increasing central (CSF) DHA levels and improving biomarker profiles in elderly adults. To assess this hypothesis, the following aims are proposed:

SPECIFIC AIM 1: To compare the effects of LPC-DHA and TAG-DHA supplementation on peripheral and CSF DHA levels in elderly adults experiencing early signs of cognitive/memory decline.

SPECIFIC AIM 2: To compare the effects of LPC-DHA and TAG-DHA supplementation on neurotrophic and neurodegenerative biomarkers.

Secondary Aim: To investigate whether changes in CSF DHA levels correlate with changes in objective measures of executive functioning and episodic memory performance.


Eligibility Criteria:
Inclusion Criteria:

1. men and women 62 to 80 years old;
2. presence of subjective cognitive decline using the SCD questionnaire, DEX and EMQ, education-adjusted MoCA score of \&gt;23 \[106,107\]; CVLT cumulative acquisition score \&gt;1.5 SD below the age-adjusted mean, and preservation of independence in functional abilities, as corroborated by an informant providing information on the mCDR \[108\];
3. No contraindication to a lumbar puncture (e.g., thrombocytopenia, coagulopathy, concomitant use of anticoagulant medications, etc.);
4. fluency in English;
5. ability to comprehend and comply with the research protocol; and
6. provision of written informed consent.

Exclusion Criteria:

1. diagnosis of MCI, AD, Parkinson's disease, frontotemporal dementia, multi-infarct dementia, significant head trauma, epilepsy, leukoencephalopathy, or other neurological condition;
2. self-reported emotional disorder such as severe depression or other psychiatric condition causing a persisting decline in functional capability;
3. diagnosis of diabetes, pancreatic, liver, kidney or hematological coagulation disorder;
4. allergy to shellfish or seafood;
5. current or past substance use causing physiological dependence or persisting change in functional capability;
6. concomitant, regular use of medications that might affect outcome measures or adversely interact with the study product including anticoagulant medications;
7. weekly fish consumption \&gt;1 x 3 oz servings and/or use of DHA-containing supplements within 3 months prior to screening.
Transplantation of Autologous Cardiac Stem Cells in Ischemic Heart Failure

This study is a prospective, randomized, double blind , controlled trial to assess the efficacy of intracoronary transplantation of autologous cardiac stem cells in 50 patients with ischemic heart failure.

Heart failure is a common, costly, disabling, and potentially deadly condition. Heart transplantation is the ultimate approach to treating heart failure, but this is costly and excludes patients who are poor candidates for transplantation given their co morbidities, or for whom a donor organ is unavailable. Currently, there is no effective intervention to regenerate dead heart muscle after a heart attack. Our hypothesis is that CSCs regenerates myocardium. In this study all eligible patients are randomly allocated into two study groups by a permuted block randomization method: group A (case group) received 5-10 millions autologous cardiac stem cells, group B (control group) just received placebo. They follow up for 18 months.

Eligibility Criteria:
Inclusion Criteria:

* 1- EF≤40 (by Echocardiography) 2- Not responding to standard therapies for heart failure \>1m 3- NYHA class ≥ III 4- Myocardial infarction due to coronary artery atherosclerotic disease 5-An area of regional dysfunction, i.e., hypokinetic, akinetic, or dyskinetic (echocardiography or MRI) 6-No HIV/Viral hepatitis 7-Normal liver function (SGPT \< 3 times the upper reference range) 8-No or controlled diabetes (hemoglobin A1C \< 8.5%) 9- Ability to provide informed consent and follow-up with protocol procedures

Exclusion Criteria:

* 1 prior ICD placement(\<2w)/Sustained ventricular arrhythmias 2-Cardiogenic shock 3- pregnancy and Child-bearing 4- Congenital / valvular heart disease
Effect of Prone Positionning in Non Intubated Patients

Retrospective single center study on the effect of awake prone positioning in ICU patients with severe hypoxemia related to SARS-COV2

Retrospective, observational study on the effects of awake prone positioning on oxygenation, invasive mechanical ventilation requirement and mortality in non intubation patients with severe hypoxemia related to SARS-COV2 and regardeless of the oxygen supplementation method.

Eligibility Criteria:
Inclusion Criteria:

* All adult (\> 18 years) patients, non intubated, with acute respiratory failure due to COVID-19 pulmonary infection

Exclusion Criteria:

* patients: hemodynamic instability and high doses of vasopressors
* patients with contraindications of prone positioning: pregnancy, recent abdominal surgery
* patients with pulmonay embolism
* patients requiring invasive mechanical ventilation for extra respiratory reasons: neurological failure, urgent surgery
Effects of Physiotherapy Via Telerehabilitation in Patients With COVID-19

This study aims to evaluate the effects of Physiotherapy Via Video Calls on Cardiopulmonary Functions, Physical Function, Cognitive Function, Activity Daily Livings, and Quality of Life in Patients With COVID-19.

A 2-armed, parallel-group, randomized controlled trial was conducted at Chulabhorn Hospital, Thailand on a convenience sample of patients who tested positive for COVID-19 using RT-PCR.

Eligibility Criteria:
Inclusion Criteria:

* Age between 20-60 years old
* Positive in COVID-19 testing
* Good communication and understanding
* Independent mobility

Exclusion Criteria:

* Cannot complete the study protocol
Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers

The purpose of the study is to characterize how PF-05212384 is metabolized in the body following a single intravenous dose of radioactively labeled drug (\[14C\]-PF-05212384).


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 30- 65 years vasectomised or \>40 with no desire to father children in the near future (12 months), inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight \>50 kg (110 lbs).
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Subjects agree to use an adequate method of contraception

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen or history of drug or alcohol abuse in the past 2 years.
Perioperative Dexamethasone Reduces Postoperative Pain and Nausea After Periacetabular Osteotomy

The purpose of this study is to assess the effect of Dexamethasone on postoperative pain and nausea after periacetabular osteotomy.

Bernese periacetabular osteotomy (PAO) is a standard procedure with good mid and long-term results. Postoperative pain is a great concern and postoperative pain management of great importance. High demand for opiates and the associated side effects especially nausea limit the postoperative rehabilitation.

Promising results to reduce postoperative pain and nausea have been achieved by perioperative dexamethasone, which has a strong anti-inflammatory effect reducing pain and inflammation as well as a strong anti-emetic effect, especially in total hip replacement.

It is our goal to compare the effect of perioperative intravenous dexamethasone (3x 4mg Amp. Fortecortin =12mg prior to surgery and 3x4mg Amp. Fortecortin = 12mg at 8.00am of the first postoperative day) to a control group (placebo) (3ml saline solution postoperative day 1 at 8.00am) regarding pain level, opiate consumption, postoperative nausea and patient satisfaction.

A double-blinded prospective randomized control trial including up to 60 patients receiving elective unilateral PAO will be conducted.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* General anasthesia
* Elective periacetabular osteotomy for any reason
* Written informed consent as documented by signature (Appendix Informed Consent Form)
* Competent German language skills

Exclusion Criteria:

* Chronic pain patient, chronic lower back pain
* Steroid or immunosuppressive drugs used within 6 months of surgery
* Renal failure, hepatic failure
* Relevant allergies
* Pregnancy/ Breast feeding
* Contraindications for Fortecortin treatment according to Swissmedic
* Previous enrollment into the current study
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Known or suspected non-compliance, drug or alcohol abuse Illness according to "Warnings and Precautions of Dexamethasone and NaCl"