cyrilzakka/clinical-trials huggingface dataset:
HIT in Insulin-resistant and Insulin-sensitive Obese Adolescents

Evaluate the effects of HIT on the cardiorespiratory performance and substrate oxidation of insulin-resistant and insulin-sensitive obese adolescents.

Objective: To evaluate the effect of high-intensity interval training (HIT) on the cardiorespiratory performance and substrate oxidation pattern in insulin-resistant and insulin-sensitive obese adolescents.

Eligibility Criteria:
Criteria

Inclusion Criteria:

* aged 12-16 years
* with a body mass index z-score (zBMI) ≥ + 2SD
* puberty stage \> 3
* the boys and girls had to present a minimum physical fitness, according to the International Physical Activity Questionnaire (IPAQ), according to the activity performed during the last week and confirmed this using the peak cardiopulmonary test (VO2).

Exclusion Criteria:

* individuals undergoing drug treatment for weight control;
* indiviudals who had cardiac, orthopedic, respiratory or renal problems, diabetes, uncontrolled hypertension, genetic syndrome or hormonal abnormalities.
Different Montages of Transcranial Direct Current Stimulation Tongue Strength

20 healthy subjects will be split into 4 groups. Each group will receive one of the following tDCS montages : anodal, bilateral, cathodal or placebo Subjects will receive 2mA for 20 mins of their attributed tDCS. The evaluation is a maximal strength test measured with the IOPI and will take place prior to, immediately following and 30 minutes after stimulation


Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin and Patient Support Program in Patients With Chronic Hepatitis C

The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well controlled conditions.

This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to local label, under real world conditions in the Netherlands in a clinical practice patient population.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve or -experienced adult male or female participants with confirmed CHC, genotype 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± RBV according to standard of care and in line with the current local label.
* If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy).
* Participants must voluntarily sign and date informed consent prior to inclusion into the study

Exclusion Criteria:

* Patients participating or intending to participate in a concurrent interventional therapeutic trial.
* Unable to complete the questionnaires due to cognitive impairment or lack of any kind of cognitive competence, as to be judged by the healthcare professional who is treating the patient.
* Unable to complete the questionnaires due to language incompetence.
* Unable to voluntarily sign and date the informed consent.
Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy

This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2 Capsule Endoscopy.

The preparation regimen used for the PillCam® Colon 2 procedure consists of several colon cleansing materials.

Different combinations of the above regimen were tested and evaluated for safety by monitoring of adverse events in multiple clinical studies, with more than 1000 subjects enrolled to date. No Serious Adverse Events related to the preparation were noted.

In this study, each subject will be required to undergo serum chemistry tests (blood tests) at several time points to evaluate the safety of the regimen.

No capsule ingestion is involved.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 50 - 75 years of age.
2. Subject is healthy without any known disease, or any current symptoms of any disease or other abnormal condition.
3. Subject received an explanation about the nature of the study and agrees to provide written informed consent.
4. Subject has normal serum chemistry tests at baseline.

Exclusion Criteria:

1. Subject has any allergy or other known contraindication to the medications used in the study.
2. Subject with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
3. Subject has Type 1 or Type II Diabetes.
4. Subject has any condition which precludes compliance with study instructions.
5. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
6. Subject suffers from life threatening conditions.
7. Concurrent participation in another clinical trial using any investigational drug or device.
A Study of SMT19969 Compared With Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhoea (CDAD)

The purpose of this research study is to evaluate the safety and effectiveness of a new oral antibiotic called SMT19969 in treating C. difficile Infection (CDI).


Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Clinical diagnosis of CDAD plus laboratory diagnostic test
* No more than 24 hrs antimicrobial treatment for current CDAD episode
* No more than 3 episodes of CDAD in prior 12 months
* No previous episode of CDAD within 30 days of study enrollment
* Female subjects of childbearing potential must use adequate contraception

Exclusion Criteria:

* Life-threatening or fulminant colitis
* Concurrent use of antibiotics or any other treatments for CDAD
* History of inflammatory bowel disease (ulcerative colitis, Crohn's disease)
* Participation in other Clinical research studies within one month of screening
Singing Groups for Seniors: Well-Being, Cognitive Function and Health

The researchers' implement and measure the effects of a singing group intervention program for older adults, with an RCT design, in a natural context, on the health, well-being and cognitive function of older adults.

Background: Singing is a multimodal activity that requires physical, cognitive and psychosocial performance, with benefits in various domains of health and well-being of older adults. In recent years, research has increasingly studied group singing as an important cost-effective intervention to promote active and healthy aging. However, the specific factors responsible for these benefits need further experimental support, as most studies do not allow for causal inferences. This study responds to the need for further randomized controlled trials (RCT), with follow-up measurement, on the benefits of group singing in older adults with diverse socioeconomic status. Also, while most studies often focus on specific outcome measures dimensions, in this study, the conjoint effects of physical, psychosocial, emotional and cognitive dimensions are analyzed, testing mediation and moderation effects of psychosocial and cognitive variables in the health and well-being of the participants. Methods: The team implements and measures the effects of a singing group program for older adults, with an RCT design, in a natural context, before and after the intervention and in a follow-up, four months after the intervention. Participants: 140 retired older adults (\> 60 years), users of a social care institution, were invited to participate in a singing group program and randomly allocated to an experimental intervention group (n = 70), and a control (n = 70) group enrolled in the regular activities proposed by the institution. The intervention consists of 34 bi-weekly group singing sessions, of two-hours each, for four months. Measures on social and emotional well-being, cognitive function, and health indicators (as blood pressure, glycemia, cholesterol, c-reactive protein, erythrocyte sedimentation rate, respiratory function, body balance, body activity, sleep quality, medication intake, and health services attendance) will be collected. Interviews on the motivation and perceived benefits of participation will also be collected. Discussion: Significant improvements are expected in the outcome measures in the experimental group after the intervention, in comparison with the control group and the pretest, validating the singing group program as a cost-effective intervention for healthy aging. Psychoemotional, psychosocial and cognitive variables are expected to be mediators of the effects of the program on the health and well-being of the participants.

Eligibility Criteria:
Inclusion criteria:

* Being 60 years old or older;
* Retired;
* Accept the invitation to participate in the singing group program;
* Not having participated in other intervention programs in the previous four months.

Exclusion criteria:

* Having a severe impairment, that is disabling for the participation in the singing group activity (e.g. severe cognitive, auditory, visual or mobility impairments).
Appropriate Evaluation of Antiviral Therapy With Nirmatrelvir-ritonavir in Hospitalized Patients

The primary objective of the study was to assess the appropriateness of antiviral therapy with nirmatrelvir-ritonavir in hospitalized patients.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized patients receiving at least one dose nirmatrelvir-ritonavir

Exclusion Criteria:

* None
AMG 162 (Denosumab) Phase 3 Study (DESIRABLE Study) in Participants With Rheumatoid Arthritis on Disease-modifying Antirheumatic Drugs (DMARDs) Treatment

To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously to rheumatoid arthritis participants.

To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously at a dose of 60 mg every 6 months or every 3 months for 12 months to rheumatoid arthritis participants.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria for rheumatoid arthritis classification (1987 revision) or the 2010 ACR-EULAR (The European League Against Rheumatism) classification criteria for rheumatoid arthritis

Exclusion Criteria:

* Functional class IV according by the ACR revised classification (1991)
A Safety Study of LY3493269 Given as a Single Injection in Healthy Participants

This study is being conducted to determine the side effects related to LY3493269 given as a single injection to healthy participants. Blood tests will be performed to check how much LY3493269 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3493269 or placebo. The study will last up to approximately 71 days for each participant, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy male or a female who cannot get pregnant
* Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening
* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
* Have veins suitable for ease of blood sampling

Exclusion Criteria:

* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
* Have previously completed or withdrawn from this study
* Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Have been treated with weight loss medications within 3 months of screening
A Comparison Between Two Oral Hypoglycemics - Metformin and Glybenclamide for the Treatment of Gestational Diabetes Mellitus

Rationale Gestational diabetes mellitus (GDM) complicates 5-7% of pregnancies. Major hazards include macrosomia, polyhydramnios, labor trauma and neonatal hypoglycemia. The ADA and ACOG recommend glucose control in order to reduce the incidence of hyperglycemia induced complications. Glucose control can be achieved using diet and life style changes. Insulin is initiated in women who fail to obtain glucose control with diet alone. During the past 11 years oral hypoglycemic drugs have been tested and proven to be efficacious and safe.

Objectives

1. To compare the efficacy and safety of glybenclamide vs. metformin in the treatment of women diagnosed with GDM
2. To evaluate the improvement in glycemic control after the addition of a second oral hypoglycemic drug after failure of the first

Hypothesis GDM is one of the major conditions contributing to obstetrical complications and prenatal morbidity. Improving glycemic control, by means of improving compliance and patient satisfaction, will decrease obstetrical complications, maternal and neonatal morbidity and have positive long term health implications.

Study design Prospective, randomized, open label

Study population Women between the ages 18-45, diagnosed with GDM will be recruited. GDM will be defined by a pathological OGTT (according to Carpenter and Coustan criteria) performed at or after 13 weeks of gestation.

Study period From recruitment until discharge of the newborn baby after delivery

Study protocol Women will be randomized at recruitment. Demographic and obstetrical data will be collected. Average glucose levels during the previous two weeks, estimated fetal weight and amniotic fluid index, and lab exams reflecting glycemic control will be noted. Women will provide daily glucose levels via fax or mail once a week. Glycemic control will be evaluated by a daily chart, including 7 measurements: 3 preprandial, 3 postprandial and a 7th measurement at 10 pm. Women will be invited to a monthly follow-up, which will include a sonographic evaluation of fetal weight and amniotic fluid, and lab exams. Follow-up protocol after 38 w of gestation will be according to our ward's protocol. The study was approved by the local Helsinki committee.

Time table Duration: two years


Eligibility Criteria:
Inclusion Criteria:

1. Patients with GDM with a gestational age between 14-33 weeks
2. Fasting glucose over 95 mg% or over 130 mg% an hour and a half postprandial (PPD) or a daily average over 100 mg%
3. At least a week of dietary treatment
4. Sonographic dating of the pregnancy earlier than 24 weeks
5. Signing a consent form

Exclusion Criteria:

1. Suspected IUGR earlier than 24 week of gestation
2. Major fetal malformation
3. Pre-gestational diabetes mellitus
Reducing Free Sugar Intakes: A Role for Sweet Taste II

This randomised controlled trial aims to assess the effects of three different types of dietary advice for reducing free sugar intakes, on intakes of free sugar, in a sample of the UK population.

The primary objective of this randomised controlled trial is to assess the effects of three different types of dietary advice, for reducing total energy intakes (TEI) of free sugars. A total of 150 participants (age 18-65 years) consuming diets \>5% total energy intake from dietary free sugars will be recruited from across the Dorset region. All participants will be asked to reduce their free sugar intake to \<5% TEI, and to aid with this, they will be encouraged to reduce their intakes of specific foods identified as high in free sugars. Participants will also be advised to replace these foods with other foods dependent on their taste. Participants will be randomised to replace high sugar foods with: 1) foods that are low in sugars, but high in sweet taste; 2) food that are low in sugars, but high in other tastes; and 3) foods that are low in taste. The primary outcome will be changes in free sugar consumption from baseline to endpoint at week 4. Secondary outcomes will include change in: BMI; dietary profiles; sweetness preference; sweetness liking; food choices; low calorie sweetened food intakes and adherence levels at week 4.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18-65 years;
2. able to provide consent and complete all study materials;
3. consuming \>5% of TEI from free sugars;
4. residing in the South of England, and able to attend Bournemouth University for testing.

Exclusion Criteria:

1. individuals who are pregnant or breastfeeding;
2. underweight (BMI \<18.5);
3. have pre-existing clinical conditions such as diabetes mellitus, eating disorders, Crohn's disease and other illness's leading to participants receiving external nutritional advice and dietary restrictions;
4. have pre-existing medical conditions affecting swallow ability, taste and smell perception;
5. currently following a specific dietary programme (e.g.: Slimming World);
6. current smokers or have smoked within 3 months of the study start date.
Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

To determine the safety and IOP-lowering ability of a test compound in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
* logMAR visual acuity not worse than 0.6.

Exclusion Criteria:

* Clinically relevant ophthalmic or systemic conditions may be excluded.
Spinal Manipulation and Dry Needling Versus Conventional Physical Therapy in Patients With Cervicogenic Headache

The purpose of this research is to compare two different approaches for treating patients with cervicogenic headaches: non-thrust mobilization and exercise versus thrust manipulation and dry needling. Physical therapists commonly use all of these techniques to treat cervicogenic headaches. This study is attempting to find out if one treatment strategy is more effective than the other.

Patients with cervicogenic headaches will be randomized to receive 1-2 treatment sessions per week for 4 weeks (up to 8 sessions total) of either: (1) Dry Needling and HVLA thrust manipulation group, or the (2) Exercise and non-thrust mobilization group

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
2. Headache frequency of at least one per week for a minimum of 3 months
3. Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50

Exclusion Criteria:

1. Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
2. Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumors, fracture, metabolic diseases, RA, osteoporosis, history of prolonged steroid use, etc.
3. History of whiplash injury within the last 6 weeks
4. Diagnosis of cervical stenosis
5. Bilateral upper extremity symptoms
6. Evidence of CNS involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes).
7. Two or more positive neurologic signs consistent with nerve root compression, including any 2 of the following:

   1. Muscle weakness involving a major muscle group of the upper extremity.
   2. Diminished UE deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
   3. Diminished or absent sensation to pinprick in any UE dermatome.
8. Prior surgery to neck of thoracic spine
9. Involvement in litigation or worker's compensation regarding their neck pain and/or headaches
10. PT or chiropractic care treatment for neck pain or headaches in the 3 months prior to baseline exam.
11. Any condition that might contraindicate spinal manipulative therapy.
A Trial of Homeopathic Medication TRAUMEEL S for the Treatment of Radiation-Induced Mucositis

The specific aim of this study will be to determine the safety of TRAUMEEL S for mucositis in head and neck cancer patients undergoing radiation therapy.

Oral mucositis is a debilitating side effect of radiation therapy for head and neck cancer patients. The severe inflammation of the oral cavity can be detrimental to quality of life and cause interruption in vital cancer treatment. Despite numerous proposed therapies, an effective agent for oral mucositis has yet to be found. TRAUMEEL S, a homeopathic remedy made up of highly diluted botanical extracts and minerals, has shown benefit for mucositis in children undergoing chemotherapy. The objective of this study is to evaluate the safety of TRAUMMEL S in the prevention and treatment of radiation-induced oral mucositis. The patients will use the medication as a mouthwash during radiation therapy and will be evaluated weekly with physical examination criteria and questionnaires for symptoms and side effects.

Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer patients post resection of primary tumor with negative or microscopically positive surgical margins
* Patients undergoing planned radiation therapy
* Age 18 to 99
* Nonsmokers

Exclusion Criteria:

* Head and neck cancer patients post resection of primary tumor with grossly positive surgical margins
* Patients receiving adjuvant chemotherapy
* Pediatric patients (age \< 18)
* Pregnant women