cyrilzakka/clinical-trials huggingface dataset:
A Phase 1 Multiple-Dose Escalation and Single Dose (Tablet) Study of PF-04171327 in Healthy Volunteers

The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics (how the drug effects certain target sites of activity in the body) of escalating doses of oral PF-04171327 in healthy volunteers for 14 days (Part 1). Part 2 will evaluate the pharmacokinetics of a single 10 mg dose of the PF-04171327 tablet in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males between 18 and 55 years, inclusive.
* Healthy females between 18 and 44 years, inclusive.

Exclusion Criteria:

* Evidence or history of clinically significant disease;
* Post-menopausal women;
* History of intolerance or significant adverse effects with glucocorticoids. therapy.
Estrogen Modulation of Mood and Cognition Following Monoaminergic Depletion in Post-Menopausal Women

This study will examine whether estrogen administration in postmenopausal women can alter the response to changes in brain chemistry brought about by dietary manipulation. Women who are recently menopausal (50-60 yrs. of age) and over 20 years postmenopausal (\>70 yrs. of age) will take estrogen or placebo for three months. At the end of that time they will participate in three challenges using dietary techniques to briefly change the relative amounts of neurotransmitters in the brain that are believed to be related to mood regulation (serotonin, dopamine, and norepinephrine). Previous research has shown that these dietary manipulations can briefly produce negative changes in mood. The investigator hypothesizes that estrogen administration will blunt or buffer these negative effects in a quantifiable way. The investigator believes that this will provide a direct test of the ability of estrogen to meaningfully change the brain chemistry of mood in a clinically measurable and positive way. The proposed procedure will also allow assessment of the effects of estrogen on brain neurotransmitter systems after many years of very low estrogen levels.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal
* Non-smoker
* BMI \<30
* Healthy
* Without surgically-induced menopause
* Not on HRT or \>1 year post HRT
* Normal mammogram within last year
* No cardiovascular disease other than mild hypertension
Prognostic Value of Central and BracHial Ambulatory Blood Pressure Monitoring in ERSD Patients Treated With HeMOdialysis

This is a prospective cohort study which aims to explore the significance of brachial and central ambulatory blood pressure monitoring in predicting cardiovascular risk in patients with end stage renal disease who are treated with hemodialysis. Enrolled patients will receive a 48-hour central and brachial ambulatory blood pressure monitoring at its first-time dialysis after enrollment. And their cardiovascular events and deaths at first and third year will be followed-up.

The protocol of this study was approved by the local ethical review board. The including criteria: 1) ESRD treated with hemodialysis for more than 3 months prior to study enrollment; 2) agree to participate the study and sign informed written consent; 3) available for long-term follow-up. The excluding criteria: 1)chronic atrial fibrillation or other cardiac arrhythmia; 2) nonfunctional arteriovenous fistula in the contralateral brachial area of the one used for dialysis; 3) myocardial infarction, angina pectoris and ischemic stroke during the previous month; 4) congestive heart failure class IV based on the New York Heart Association classification; 5) malignancy or any other condition with poor prognosis; 6) antihypertensive treatment during one month prior to enrollment. After enrollment, every patient will receive a question-based interview to obtain medical history and the following examinations and tests: anthropometric parameters measurement including body height, weight; biochemical tests including vein blood and urine. At the first-time dialysis after enrollment, patients will receive 48-hour central and brachial ambulatory blood pressure monitoring using a well validated and commercial device Mobil-O-Graph (IEM, Germany). Brachial blood pressure are measured for each patient before every dialysis for at three month. Then one-year and three-year cardiovascular events and deaths will be followed-up. The primary outcome measures are as follows: deaths and cardiovascular events including nonfatal myocardial infarction, unstable angina, stroke, hospitalization for heart failure, or resuscitated cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* patients with end-stage renal disease treated with hemodialysis for more than 3 months prior to study enrollment;
* agree to participate the study and sign informed written consent;
* available for long-term follow-up.

Exclusion Criteria:

* chronic atrial fibrillation or other cardiac arrhythmia;
* nonfunctional arteriovenous fistula in the contralateral brachial area of the one used for dialysis;
* myocardial infarction, angina pectoris and ischemic stroke during the previous month;
* congestive heart failure class IV based on the New York Heart Association classification;
* malignancy or any other condition with poor prognosis;
* antihypertensive treatment during 1 month prior to enrollment.
MSD Belzutifan PAS

This is a prospective observational cohort study evaluating the effectiveness and safety of belzutifan treatment in routine clinical practice.

This study has been registered and will be maintained through close out on the RWD Catalogues Observational Registry - https://catalogues.ema.europa.eu/ under the EU PAS number:

EUPAS108114

Primary Objective

* Among new users of belzutifan with VHL disease-associated RCC, to describe the proportion of patients who undergo at least one renal tumor reductive surgery (e.g., nephrectomy) or locally directed therapy (e.g., radiofrequency ablation).
* Among new users of belzutifan with VHL disease-associated CNS hemangioblastoma, to describe the proportion of patients who undergo at least one CNS tumor reductive surgery (e.g., craniectomy) or locally directed therapy (e.g., radiation therapy).

Secondary Objectives

Among all new users of belzutifan to describe:

- Proportion of patients with treatment emergent SAEs, including the nature of these events.

Treatment patterns including the:

* Duration of therapy
* Proportion of patients who discontinued treatment, time to treatment discontinuation, and summary of reasons for discontinuation
* Proportion of patients who interrupted treatment, time to treatment interruption, duration of treatment interruption, and summary of reasons for treatment interruption
* Proportion of patients with dose reductions, and reason for dose reduction.
* Among new users of belzutifan with VHL disease-associated RCC and, separately, VHL disease-associated CNS hemangioblastoma, to describe:
* Proportion of patients who develop metastatic disease (for RCC only)
* Proportion of patients with occurrence of new VHL disease-associated tumor or tumor type

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years of age
* Diagnosed with VHL disease based on a germline test or clinical diagnosis
* A decision has been made by the treating physician (at his/her discrestion) to intitate the first belzutifan treatment (i.e., belzutifan 'new users'), within the prescribing conditions of the approved product label
* Signed informed consent prior to or withing 30 days after the first inititaion of belzutifan

Exclusion Criteria:

* Anti-cancer systemic therapy within 2 weeks prior to the index date
* Unable to consent to participate in the study
* History of VHL disease-related metastasis or advanced cancer
Population Pharmacokinetic Analysis of Daptomycin in Patients With Osteoarticular Infections

Daptomycin is validated as a treatment of bone and joint infections by the Infectious Disease Society of America. However, most of studies did not investigate daptomycin pharmacokinetics in this indication while it is known that efficacy and toxicity concentration studies show a close therapeutic margin.

Evaluation of P-Glycoprotein (P-gp), a transmembrane transport protein, has demonstrated its influence on the concentration and intracellular activity of daptomycin. Recent work has linked the genetic polymorphism of P-gp to the pharmacokinetics of daptomycin, which may explain inter-individual variability but requires further explorations. Previous studies demonstrated existence of interindividual variabilities as sex, renal function and p-glycoprotein polymorphism couple with an intraindividual variabilities unexplained yet.

A population approach will be used to determinate the pharmacokinetics factors, their intra and interindividual variabilities, the parameters associated to those variabilities (as the p glycoprotein).

The investigator's goal is to evaluate different posology and to try to increase daptomycin efficacy and security in bone and joint infection.


Eligibility Criteria:
Inclusion Criteria:

Patients

* having had a bone or joint infection, with or without implant,
* having an antibiotherapy with daptomycin between December 2012 and December 2016 at the Croix-Rousse hospital
* are at least 18 years old

Exclusion Criteria:

* None
Safety and Efficacy of the Therapeutic Vaccine GI-4000 in Combination With Gemcitabine Versus Placebo for the Treatment of Non-metastatic, Post-resection Pancreas Cancer

The GI-4000 therapeutic vaccine or placebo will be injected under the skin of post-resection, non-metastatic pancreas cancer patients. Patients will be monitored for recurrence as well as safety, and immune responses related to the injections.


Eligibility Criteria:
(A few general items required)

Inclusion Criteria:

* Patients with non-metastatic pancreas cancer post-resection that have a product-related ras mutation
* \>18 years of age
* Negative skin test for hypersensitivity to Saccharomyces cerevisiae

Exclusion Criteria:

* Metastatic pancreas cancer patients post-resection
* Patients with no product-related ras mutation.
Usefulness of Serum Pepsinogen and Gastrin as the Predictive Biomarker of Atrophic Gastritis, Intestinal Metaplasia and Gastric Cancer in Korea

It is well-known that atrophic gastritis is a major risk factor for gastric cancer, which leads to variations in the serum levels of gastrin, pepsinogen (PG) I, and PGII. We want to assess the effects of age, sex, and Helicobacter pylori status on pepsinogen (PG) level for atrophic gastritis and whether gastric atrophy based on the PG test would be improved after H. pylori eradication.


Eligibility Criteria:
Inclusion Criteria:

1. over 19 years
2. the patients who have gastrointestinal discomfort or get esophagogastroduodenoscopy (EGD) for health check up
3. the patients who got the procedure, endoscopic submucosal resection (ESD) for early gastric cancer

Exclusion Criteria:

1. gastrectomy history
2. advanced gastric cancer (impossible to get the gastrectomy)
3. Helicobacter eradication history
4. the patients who have chronic disease
5. cancer patients except gastric cancer within 6 months
6. who cannot perform this study according to research's decision
7. who have bleeding tendency (ex. taking antiplatelet agent, low platelet count or abnormal coagulation time)
Suspension System on Impingement Syndrome

To investigate the effect of shoulder exercise using a selected suspension system exercise program on pain, disability, functional performance and proprioception in patients with subacromial impingement syndrome.

Two groups were assigned to this study, the first one received four conventional exercises that designed for shoulder impingement syndrome, the second group received the same four conventional exercises plus four selected suspension system exercises.

The sessions were conducted three times per week fir four weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Fifty-eight subjects with SIS (more than three months).
2. Their age ranges from 20-45 years old
3. Level of pain (at least 2/10 on VAS)
4. Body mass index (BMI) between 18-25
5. Subjects must show positive results in at least two of the following tests: Neer's impingement test, Hawkins-Kennedy test, supraspinatus (empty can) test, apprehension and relocation test.

Exclusion Criteria:

The subjects will be excluded if they had:

1. Received physiotherapy at last 3 months.
2. Received corticosteroids injection in subacromial space at last 3 months.
3. Received anti-inflammatory medications.
4. Have a fracture or dislocation in shoulder, neck and thoracic regions.
5. Have an acute rotator cuff tear.
6. Have tumor or malignancy in shoulder region.
7. Have neurologic problems in shoulder, neck and thoracic regions.
8. Have cooperation difficulties due to cognitive disorders.
Glycemic Index in Subjects With Diabetes Mellitus Insulin Requesting

To evaluate the acute effect of a low and high glycemic index breakfast on the glycemic response and satiety in subjects with type 2 diabetes mellitus under intensive insulin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with type 2 diabetes mellitus diagnosis.
* Minimum period of six months under intensive insulin therapy.
* Fast insulin prescription before breakfast.
* 35 and 70 years of age.
* BMI between 25 and 39.9 Kg/m2.
* HbA1c less than or equal to 10 % (86mmol/mol)
* Menopausal women under hormone replacement therapy

Exclusion Criteria:

* Pregnant women.
* Puerperal women.
* Subjects with neurological disease, endocrine disorder no treatment, kidney disease in stage IV or V, cancer, liver disease, chronic obstructive pulmonary disease, human immunodeficiency virus.
* Subjects with history of stroke, acute myocardial infarction or gastrointestinal resection.
Effect of Omega 3 Enriched Oral Nutritional Supplement on Nutritional Status of CRC and NSCLC Patients

A single arm intervention study examining the effect of an omega 3 enriched oral nutritional supplement on nutritional status of CRC and NSCLC patients


Eligibility Criteria:
Inclusion Criteria:

1. Histologically proven CRC or histologically or cytologically proven NSCLC
2. Eligible and scheduled for at least 2 cycles of 4-week cycles of systemic treatment, 3 cycles of 3-week cycles of systemic treatment or 4 cycles of 2-week cycles of systemic treatment
3. At risk of malnutrition or malnourished \[PG-SGA-SF \> 4\]
4. Performance status ECOG 0 or 1
5. Weight loss grade 0-3 according to Martin et al1
6. \<11% weight loss in the past 6 months
7. Age ≥ 18 years
8. Written informed consent

Exclusion Criteria:

1. Presence of ileostoma or ileal pouch
2. GI-related or major surgery in 30 days prior to baseline
3. Severe hypercalcemia, i.e. total calcium level, corrected for albumin ≥ 14.0 mg/dL (3.5 mmol/L)
4. Use of ONS, enteral nutrition or parenteral nutrition within 14 days prior to entry into the study
5. Use of fish oil containing supplements, within 30 days prior to entry into the study or expected to use this during the study
6. Use of more than 200 iU/day of vitamin D containing supplements within 30 days prior to entry into the study or expected to use this during the study
7. Life expectancy of \< 3 months
8. Severe renal dysfunction (\<29 ml/min/1.73m2 eGRF or albumin:creatinine (ACR) \> 30) or hepatic encephalopathy
9. Allergy to cow's milk protein or fish, known protein sensitivity or suffering galactosemia
10. Known pregnancy or lactation
11. Current alcohol or drug abuse in opinion of the investigator
12. Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
13. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
State Mindfulness Scale for Physical Activity: Validity and Reliability

The American College of Sports Medicine (ACSM) states that physical activity is very important for healthy adults as it provides many health and psychological benefits. Physical activity is any bodily movement produced by skeletal muscles that increases energy expenditure. physical activity; It is an important health behavior that can have a positive impact on physical, cognitive, and social well-being. In the population of athletes who qualify as physically active, the focus is not on adapting to exercise or improving physical activity. However, the inability of athletes to maintain their lifelong physical activity levels after retirement can cause health problems. Because physical activity behavior patterns are lifelong, it is important to understand the factors that contribute to physical activity.

Conscious awareness; It is defined as a mindset in the form of being aware of the present moment with the features that do not judge, accept and avoid. Mindfulness is often said to require both purposeful attention and an accepting attitude. Intention is also considered an important part of awareness. There is increasing interest in the role of mindfulness in the emergence of positive health outcomes. One possible benefit of mindful practice is that it can lead to intrinsic motivation. Until recently, there was no good way to measure the specific experience of mindfulness during physical activity to support this recommendation. A new scale called the State Mindfulness Scale for Physical Activity has been developed to help researchers better understand how people feel about their physical activity.

The State Mindfulness Scale for Physical Activity is a 12-item scale to measure mindfulness during a specific physical activity. The scale is based on the Situational Conscious Awareness Scale, which measures objects (mental and physical) and the quality of situational conscious awareness. The original scale was not comprehensive enough to capture the full spectrum of physical experiences. The State Mindfulness Scale for Physical Activity was developed to assess different aspects of mindfulness (mental and physical) during physical activity to better understand the physical activity experience. There are six items that use awareness of objects of mental experience and six items that use awareness of objects of physical or physical experience. State Mindfulness Scale for Physical Activity has been successfully adapted to Spanish, Italian and Brazilian.

Despite the increase in Turkish assessment tools in the field of physical activity in recent years, psychological assessment tools are very few. The aim of this study is to translate, culturally adapt and validate the Turkish version of the State Mindfulness Scale for Physical Activity.


Eligibility Criteria:
Inclusion Criteria:

* Be a licensed athlete between the ages of 18 and 35
* Be literate in Turkish

Exclusion Criteria:

* Having an ongoing injury
Shock Wave Therapy in Individuals With Lateral Epicondylitis

A sample of 40 patients poststroke (24 males) was randomly allocated to either ESWT experimental (n=18) or conventional physiotherapy control group (n=20). All patients received 5 sessions during the treatment program. The Visual Analog Scale (VAS) and Taiwan version Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire, and dynamometer (Maximal grip strength) for each participant were assessed before and after the treatment program.

The participants in the experiment group received 5 consecutive sessions of ESWT for 5 minutes. Treatment parameters for the shock wave therapy group were set similar to a previous study (Devrimsel et al., 2013) 2000 shock waves with 1.6 bar intensity and 16 Hz frequency were applied for five sessions using the Swiss DolorClast Master (EMS, Nyon, Switzerland). The participants in the control group received 5 sessions of conventional physical therapy intervention for 5 minutes. The control group intervention consists of a 1-minute friction massage over the common extensor tendon of the elbow, followed by 3 minutes therapeutic ultrasound with a frequency of 1.5 Hz, and a 1-minute ice massage over the common extensor tendon of the elbow. All participants used 10-cm lateral epicondyle bandages in the treatment period, while none of them received analgesic or anti-inflammatory drugs and received exercise programs.

Eligibility Criteria:
Inclusion Criteria:

* An inclusion criterion was a confirmed diagnosis of lateral epicondylitis with lateral elbow pain lasting more than 6 months and less than 1 year.

Exclusion Criteria:

* Participants were excluded from this study if they had cervical radiculopathy, elbow deformity, history of diabetes mellitus, hypo- or hyperthyroidism, history of malignancy, chronic inflammatory diseases, and pregnancy. Patients who received corticosteroid injections to the lateral epicondyle within 6 weeks were also excluded.
A Smoking Cessation Treatment for Adult Women

The purpose of this study is to develop and pilot test a smoking cessation counseling that focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and negative affect, loss of enjoyment).

Aim 1: To develop the risk-based smoking cessation intervention.

Aim 2: To examine whether manualized smoking cessation counseling about the perceived risks of quitting is feasible to administer and acceptable to adult women who want to quit smoking.

Aim 3: To examine smoking cessation outcomes for women who receive the risk-based treatment in comparison to standard smoking counseling. It is expected that women who receive risk-based counseling will show better quit rates and a longer time to relapse than women who receive standard treatment.

The purpose of this treatment development study is to design and pilot test a smoking cessation intervention in which counseling sessions are tailored to individual smokers' perceived risks of quitting. The feasibility, acceptability, and efficacy of the novel treatment will be examined through a pilot study in which female smokers will be randomly assigned to receive either the tailored treatment or a standard treatment. It is expected that participants receiving the tailored treatment will show higher rates of smoking abstinence than participants receiving the standard smoking cessation treatment at the end of the 8-week treatment and at one month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 64 years old
* Meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for nicotine dependence with Fagerström Test for Nicotine Dependence (FTND) score ≥4
* Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month) and have an expired breath carbon monoxide (CO) level ≥10
* At the time of initial evaluation, are motivated to quit smoking in the next 30 days.
* Have the capacity to give informed consent, and are English-speaking.

Exclusion Criteria:

* Have a positive urine drug screen or urine pregnancy test at baseline evaluation
* Meet DSM-IV criteria for alcohol or other drug abuse or dependence in the previous 6 months
* Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder
* Meet DSM-IV criteria for a current or past diagnosis of bipolar disorder or schizophrenia
* Are currently receiving treatment for nicotine dependence (e.g., nicotine replacement therapy, bupropion, chantix)