cyrilzakka/clinical-trials huggingface dataset:
Dark Chocolate and Intestinal Motility

Following food intake, the body activates several processes to degrade and digest it. Studies show that there is an adaptation of gastric emptying and gastrointestinal motility to a food component; therefore, considering the intestinal adaptation to chocolate, the effect on gastrointestinal motility in relation to the intake of chocolate will be investigated.

The organoleptic perceptions of dark chocolate will also be analyzed to evaluate the appreciation of the product ingested by the subject.

Chocolate, the main product deriving from cocoa beans (Theobroma cacao, from the Greek "food of the gods") has its origin in Mexico, where Maya, Inca and Aztecs practiced its cultivation, has for centuries been appreciated for its pleasant taste and its beneficial health effects.

Chocolate is the most sought-after food worldwide, and currently its consumption has increased considerably with a wide availability of products on the market.

Dietary choices are strongly influenced by the taste and consistency of foods. Fat is largely responsible for the sensory properties of many foods and, therefore, contribute greatly to the pleasure of eating. Dark chocolate consists of ≈43% of lipids, mainly represented by cocoa butter. Cocoa butter is composed of an average of 33% of oleic acid, 25% of palmitic acid and 33% of stearic acid. Another component of chocolate is polyphenols, in particular flavonoids, substances with numerous beneficial effects for health, including antihypertensive, anti-inflammatory, antithrombotic, metabolic and prebiotic activity playing a role in the change of human intestinal microbiota. Recent scientific studies show an inverse correlation between the intake of flavonoids in the diet and the incidence of diabetes, such as to hypothesize the use of foods rich in flavonoids as potential food supplements in the management of diabetes. The cocoa flavonoids can bring benefits to the insulin-resistance condition by improving endothelial function, modifying glucose metabolism and reducing oxidative stress, which is considered the main cause of insulin resistance. In healthy individuals and even in patients with moderate cardiovascular risk, regular intake of flavonoids improves levels of cardiovascular biomarkers, reducing serum LDL cholesterol concentrations and triglycerides and increasing HDL cholesterol concentrations. The flavonoids present in cocoa may also inhibit platelet aggregation by down-regulation of the cellular synthesis of eicosanoids. Chocolate is an effective alternative for increasing fiber intake at recommended levels; in addition, it reduces intestinal transit time by increasing peristaltic movements.

Eligibility Criteria:
Inclusion Criteria:

* Aged 25-35 years old
* Able to sign an informed consent

Exclusion Criteria:

* Refuse to sign an informed consent
* Diagnosis of organic diseases, including neoplastic inflammatory or cardiovascular diseases
* Drugs able to influence the gastrointestinal tract or interfering with symptoms
* Pregnancy
* Presence of diseases with a prognosis inferior to a year
* Hypersensitivity to chocolate or its components
Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

To provide the efficacy, safety and pharmacokinetics of indacaterol acetate in patients with persistent asthma to support dose selection of indacaterol in fixed dose combination QMF149.


Eligibility Criteria:
Inclusion Criteria:

* Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
* Patients who are receiving ICS treatment in a stable regimen for ≥ 4 weeks
* Patients with a pre-bronchodilator FEV1 value of ≥ 40% and ≤ 80% of predicted normal value
* Patients who demonstrate an increase of \>= 12% and 200 mL in FEV1
* ACQ-5 score ≥ 1.5

Exclusion Criteria:

* Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
* Patients with chronic lung disease, including COPD, pulmonary tuberculosis, bronchiectasis, sarcoidosis, interstitial lung disease and cystic fibrosis.
* Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.

Other protocol-defined inclusion/exclusion criteria may apply
Passive Prophylaxis of Lyme Disease Using Permethrin Treated Clothes

Hypothesis: Does treatment of lower extremity clothing with permethrin prevent Lyme disease?

This is a double-blind, randomized clinical trial using permethrin treatment of clothing to prevent Lyme disease.

This is a double-blind, randomized clinical trial using permethrin treatment of clothing to prevent Lyme disease.

Subjects (N=200) will be recruited from camp staff to participate in the study and screened by inclusion and exclusion criteria.Qualifying subjects will be randomized to either the treatment (N=100) or non-treatment arm (N=100).

Subjects in the treatment arm will have their scout shorts, pants, and socks sprayed with 0.5% permethrin and allowed to dry. Subjects in the non-treatment arm will have their scout shorts, pants, and socks sprayed with water and allowed to dry.

Subjects will then be followed over the summer camping season to see if they develop Lyme disease. At 70 days, all subjects will have their Lyme titers rechecked to ensure that all cases of Lyme disease were documented.

Following the 70 day visit, there will be an assessment of the final study outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Summer camp staff at Tomahawk Scout Reservation
* Works in an outdoor environment
* Sleeps in an outdoor environment (platform tent)
* Present for the entire camp season (June - August)
* Informed consent

Exclusion Criteria:

* Contraindication, allergy or previous reaction to permethrin
* Inability of subject or surrogate (e.g., parent if \< 18 years of age) to provide informed consent
EMPOWER PD - Feasibility of an Interdisciplinary Clinic for People With Parkinson's Disease

This study is a nonrandomized, pilot study of an interdisciplinary, patient-centric model of health care delivery in a "boot camp" style structured clinic for people diagnosed with Parkinson's disease (PwPD). 20 participants will attend a three session EMPOWER PD clinic and a two month follow up interview. The primary objective is to assess feasibility and acceptability of the newly developed clinic intervention as well as individual perception of experience and barriers.

This study is a nonrandomized, pilot study of an interdisciplinary, patient-centric model of health care delivery in a "boot camp" style structured clinic for people diagnosed with Parkinson's disease (PwPD). 20 participants will attend a three session EMPOWER PD clinic and a two month follow up interview.

Participants will receive a comprehensive assessment by each member of an interdisciplinary team including physical therapy, speech therapy, nutrition, social work or psychology, and pharmacy. Participants will return the following week for a half day educational symposium. This is a group format and they will receive a session from each of the disciplines covering topics such as exercise, nutrition, communication, socialization, sleep hygiene, medication management, and coping. The final clinic session will be a one hour 1:1 meeting where individualized recommendations will be provided. A participant identified caregiver is invited/allowed to accompany the participant throughout the assessment and educational process whenever possible however, no information or questionnaires are being collected from them.

The primary objective is to assess feasibility and acceptability of the newly developed clinic intervention as well as individual perception of experience and barriers with data derived from a program survey and semi-structured interview completed two months after clinic completion. Secondary objectives will test patient response to clinic intervention related to self-reported outcome measures (SROs) including Patient Centered Outcome Questionnaire PD, PD Knowledge, quality of life, fatigue, confidence with balance, and self-efficacy for exercise.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of idiopathic Parkinson Disease
* Living in the community (not institutionalized)

Exclusion Criteria:

* A diagnosis of atypical Parkinsonism
* Institutionalized (living in a nursing home setting)
Osteoporosis in RETT Syndrome

Based on our clinical observations, many girls with RETT syndrome, a severe neuro-developmental encephalopathy, suffer from osteoporosis which can appear at a very early age (before age 10) and can lead to fractures, pain and a limitation in mobility. Few epidemiological studies have estimated the frequency of osteoporosis in girls with RETT syndrome and showed that they are more exposed then children with other neuro-developmental diseases with a same degree of neurological handicap. However, the mechanisms that lead to early osteoporosis in RETT syndrome remain unknown. Mutations in the MECP2 gene are found in 95% of RETT patients and preliminary experimental studies have shown that this can lead to abnormal expression of the gene that codes for osteoprotegerin, a protein implicated in bone remodelling by interacting with RANK-ligand.

In order to identify risk factors of osteoporosis in RETT syndrome and to understand the pathophysiological mechanisms the study protocol includes:

1. Clinical evaluation of bone health (history of bone fractures, pain, nutritional status, pubertal stage, daily caloric/calcium intake, anti-epileptic drugs, walking ability, vitamin D satus)
2. evaluation of the mineral density at the lumber spine using DEXA
3. measuring concentrations of osteoprotegerin and RANK-ligand

Based on our clinical observations, many girls with RETT syndrome, a severe neuro-developmental encephalopathy, suffer from osteoporosis which can appear at a very early age (before age 10) and can lead to fractures, pain and a limitation in mobility. Few epidemiological studies have estimated the frequency of osteoporosis in girls with RETT syndrome and showed that they are more exposed to osteoporosis then children with other neuro-developmental diseases with a same degree of neurological handicap. However, the mechanisms that lead to early osteoporosis in RETT syndrome remain unknown.

Mutations in the MECP2 gene are found in 95% of RETT patients. Preliminary experimental studies on the transcriptional consequences of MECP2 mutations showed that the expression of 13 genes were significantly dysregulated and one of them is the gene that codes for osteoprotegerin, a soluble receptor that binds to RANK-ligand. RANK-ligand is an osteoclastic differentiation factor expressed by osteoblasts.

In order to identify risk factors of osteoporosis in RETT syndrome and to understand the pathophysiological mechanisms the study protocol includes:

1. Clinical evaluation of bone health (history of bone fractures, pain, nutritional status, pubertal stage, daily caloric/calcium intake, anti-epileptic drugs, walking ability, vitamin D status)
2. evaluation of the mineral density at the lumber spine using DEXA
3. measuring concentrations of osteoprotegerin and RANK-ligand

Eligibility Criteria:
Inclusion Criteria:

* RETT syndrome
* MECP2 mutation

Exclusion Criteria:

* no identified MECP2 mutation
* history of drugs that interfere with bone metabolism
Comparison of Autologous Quadriceps and Hamstring Tendon Grafts in Anterior Cruciate Ligament Reconstruction

With the recent technological advancements, the use of the quadriceps tendon with an all-inside technique has come to the forefront, and large-scale research has focused especially on quadriceps tendon grafts. Clinical study results have reported that the outcomes are similar to those of patellar tendon grafts and either equivalent or superior to hamstring tendon grafts.

The aim of this study is the prospective comparison of the clinical and radiological outcomes of patients who underwent anterior cruciate ligament (ACL) reconstruction with autologous hamstring and quadriceps tendon grafts.


Eligibility Criteria:
Inclusion Criteria:

* Elite athletes
* Amateur athletes
* Anterior cruciate ligament injury

Exclusion Criteria:

* Revision surgery
* Another ligament injury ( medial collateral ligament, lateral collateral ligament, etc.. )
* \> Grade-2 cartilage injury
* Having previously undergone surgery on the same knee
* \< 18 years age
Redistribution of Fat and Metabolic Change in HIV Infection: Protocol 2 (FRAM Fat 2)

The purpose of this study is to learn whether HIV-infected patients have blood abnormalities which could lead to heart attack or stroke, and to find out what factors may contribute to these abnormalities.

This research is being done to learn whether HIV-infected patients have abnormalities in their blood vessels that could eventually lead to heart attack or stroke (atherosclerosis), in how fat is distributed in their body and in how their body handles fat and sugars. If there are abnormalities, this study will also try to find out what factors may contribute to those abnormalitites.

People who participated in FRAM 1 may join FRAM 2.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* previous FRAM 1 participant
* HIV positive

Exclusion Criteria:

* Artificial knee or hip replacement or Harrington rod
* Metal objects in the body.Pregnancy
* Breastfeeding or less than 3 months after breastfeeding
* Weight more than 300 pound
* On insulin, pancreatic enzymes, or thioridazine.
tDCS and Female Urinary Incontinence

Urinary incontinence (UI) is defined as any involuntary loss of urine and can be divided into three types: urgency, stress and mixed. Pelvic floor exercises are considered the main non pharmacological choice for UI treatment. Its mechanisms are not fully understood, however there are some evidence that central mechanisms play an important role in the continence control. In this context, neuromodulatory techniques, such as transcranial direct current stimulation (tDCS), that address cortical targets has been demonstrated promising results in different health conditions. However, few studies have investigated the efficacy of adding tDCS to exercise therapies for women with UI.


Eligibility Criteria:
Inclusion Criteria:

* Complaining of urinary loss
* Seeking care for urinary incontinence

Exclusion Criteria:

* Grade III vaginal dystopias
* Intrapelvic tumors
* Cardiac pacemaker or other implanted devices
* Current pregnancy
* Urinary tract infections
* Previous treatment with tDCS
Study to Evaluate the Effect of SLV320 in Addition to Chronic Furosemide Treatment on Renal Function in Subjects With Congestive Heart Failure and Impaired Renal Function

This is a randomized, double-blind, placebo-controlled, multi-center, sequential cohort study in subjects with congestive heart failure (CHF) and impaired renal function who are on stable furosemide treatment (³ 40 mg daily). A total of 50 subjects will be randomized to each increasing dose level of SLV320 or placebo in a sequential fashion.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18 to85 years who gave written informed consent.
* Subjects must have a history of chronic, symptomatic, New York Heart Association (NYHA) Class II-III CHF and impaired renal function (baseline eGFR of 20 to 75 mL/min/1.73m2).
* Congestive heart failure should have been diagnosed at least 3 months before Visit 1 (Day 1) and the subjects should be on chronic treatment with furosemide (40 mg daily) for at least 3 weeks before Visit 1 (Day 1).
* Subjects must be on stable doses of their individually optimized medication regimen for at least 4 weeks before Visit 1 (Day 1).

Exclusion Criteria:

* Any history of a convulsive disorder or pre-convulsive state and any risk for a convulsive disorder or pre-convulsive state (for example any past brain trauma, abuse of alcohol) will lead to an exclusion from the study.
* Females of childbearing potential not using specified contraception, subjects with malignant tumors with a short life expectancy, subjects with known severe reactions to drugs and subjects with bilateral renal artery stenosis will be excluded from the study.
Evaluation of the Feasibility and Efficacy of Computerized Anxiety Treatment in a Group Setting

* Statement of the Research Study. Participants are being invited to volunteer to take part in our research study. It is up to participants whether to choose to take part or not. There will be no penalty or loss of benefits to choosing not to take part or decide later not to take part.
* Purpose. The reason that the researchers are doing this research is to evaluate the effectiveness and feasibility of administering a computerized anxiety intervention in a setting of five or more individuals. This intervention has already been tested and shown promise with individuals, and researchers want to see if it will function in a group setting as well.
* Duration. Researchers think that taking part in our study will last approximately two hours, with an additional follow-up survey one month later to be completed at home via computer or smartphone.
* Research Activities. Participants will first be asked to complete several questionnaires dealing with your thoughts and feelings. Once these questionnaires are completed, participants will be assigned to one of two groups, with each group viewing one of two computerized presentations and completing some group exercises afterward. Once participants have completed the designated intervention, participants will then be asked to fill out surveys once again, which will complete the study appointment. One month following the appointment, participants will be sent surveys once again and will be asked to complete them at home.

Risks: The risks or discomforts to participants while taking part in this research include temporary distress or anxiety pr potentially feeling mild discomfort answering questions about your thoughts and feelings.

Benefits: As a result of taking part in this research, participants may experience improvements in mental health.


Eligibility Criteria:
Inclusion Criteria:

* adults aged 18+ and ability to use a computer or smartphone.

Exclusion Criteria:

* inability to engage in any interoceptive exercises.
Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee

This study consists of a randomized, double-blind, placebo-controlled crossover trial with open label extension evaluating a topical natural health cream containing ß-caryophyllene alone and in combination with 0.025% capsicum oleoresin against placebo. At the end of the randomized controlled phase of the trial all participants will be given open-label combination cream to be administered over the subsequent 3 weeks.

Primary Endpoint: Evaluation of improvement in pain interference as measured by the BPI in individuals who are experiencing pain due to osteoarthritis of the knee.

Secondary Endpoints: Secondary endpoints are: Confirmation of safety of the topical cream when used daily over 10 weeks.

Further evaluation will include overall patient satisfaction with the products tested.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee according to American College of Rheumatology criteria: Knee pain with 3 of the following:

  * age \>50 years
  * stiffness less than 30 min
  * crepitus,
  * bony tenderness,
  * bony enlargement,
  * no palpable warmth
* Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
* All concurrent medications taken for any reason stable for 14 days
* Ability to follow protocol with reference to cognitive and situational factors (e.g. stable housing, ability to attend visits)
* Ability to read and write English
* Willing and able to give informed consent

Exclusion Criteria:

* Currently using other topical agents for treatment of pain or inflammation
* Use of glucosamine, methysulfonylmethane or other regular anti-inflammatories within 2 weeks prior to completing baseline pain measure and during the trial
* Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (e.g. cancer, immunosuppressed)
* Pregnant and breastfeeding women.
* Type I or Type II diabetes and other endocrine disorders
* Use of exercise or transcutaneous electrical nerve stimulation prior to and during the trial
* A history or present disease (i.e. inflammatory, infectious joint disease) which may affect the outcome of the trial
* Currently taking NHPs for joint health
* Currently enrolled in other clinical trial involving a pharmaceutical treatment
A Clinical Study to Investigate the Potential Interactions Between Food and ACT-541468 and Between ACT-541468 and Midazolam

The main objectives of this phase 1 trial are to evaluate the effect of food on the pharmacokinetics (i.e. how long and how much a compound is present in the blood) of ACT-541468 and to evaluate whether ACT-541468 can affect the pharmacokinetics of midazolam, a CYP3A4 substrate.

Food effect will be assessed by comparing the pharmacokinetic (PK) parameters of a single dose of ACT-541468 under fasted (Treatment B) and fed (Treatment C) conditions.

Potential CYP3A4 inhibiting / inducing effects of ACT-541468 will be assessed by comparing the PK parameters of midazolam alone (Treatment A) and midazolam given with a single dose of ACT-541468 (Treatment B) or with multiple doses of ACT-541468 (Treatment D).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Male subjects aged from 18 to 45 years (inclusive) at screening
* Body mass index (BMI) from 18.0 to 30.0 kg/m2 (inclusive) at screening
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests

Exclusion Criteria:

* Any contraindication to the study treatments
* History or clinical evidence of any disease or medical / surgical condition or treatment, which may put the subject at risk of participation in the study or may interfere with the absorption, distribution, metabolism or excretion of the study treatments
* History of narcolepsy or cataplexy or modified Swiss narcolepsy scale total score \< 0
* Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol