cyrilzakka/clinical-trials huggingface dataset:
Alternate Day Fasting Combined With a High Protein Background Diet

The aims of this study are as follows: AIM 1: To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance).

Background: Accumulating evidence suggests that alternate day fasting (ADF) is an effective diet strategy to help individuals with obesity lose weight and lower metabolic disease risk. ADF regimens include a "feast day" where food is consumed ad-libitum over 24 h, alternated with a "fast day" where intake is limited to \~600 kcal over 24 h. What has yet to be elucidated is whether consuming a high protein diet (as meal replacements) during ADF is effective for weight loss, weight maintenance, and metabolic disease risk reduction in individuals with obesity.

Objective: The aims of this study are as follows: AIM 1: To examine the weight loss and weight maintenance efficacy of an alternate day fasting-high protein (ADF-HP) diet; AIM 2: To examine the effects of an ADF-HP diet on metabolic disease risk factors (plasma lipids, fasting glucose, fasting insulin, insulin resistance).

Methods: A 24-week, single-center, longitudinal pilot study will be conducted to test the study objectives. The trial will be divided into 2 consecutive intervention periods: (1) 12-week weight loss period, and (2) 12-week weight maintenance period. Subjects with obesity will participate in an ADF-HP: alternate day fasting-high protein diet: 600 kcal "fast day" alternated with ad libitum "feast day", 35% kcal as protein. ADF-HP subjects will consume the Optifast HP Shake Mix (Nestle) on each day of the trial. Body weight, insulin, glucose, and insulin resistance, will be measured at baseline, week 12, and week 24.

Significance: These findings may show that alternate day fasting combined with high protein meal replacements may be implemented as an effective diet therapy to help individuals with obesity lose weight, maintain weight loss, and sustain reductions in metabolic disease risk.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 65 years old
* BMI between 30.0 and 49.9 kg/m2
* Previously sedentary or lightly active

Exclusion Criteria:

* Diabetic
* History of binge eating disorder
* Taking weight loss-inducing medications
* Not weight stable for 3 months prior to the study (weight gain or loss \> 4 kg)
* Perimenopausal or have an irregular menstrual cycle (menses that does not appear every 27-32 days)
* Pregnant or trying to become pregnant
* Night shift worker
* Smokers
A Study to Assess the Effect of BMS-986142 on Pharmacokinetics (PK) of Probe Substrates

The study is being conducted to assess the effect of BMS-986142 on the single-dose PK parameters of montelukast, flurbiprofen, omeprazole, midazolam, and digoxin, probe drugs for (cytochome P450) CYP2C8, CYP2C9, CYP2C19, CYP3A4, and P-glycoprotein (P-gp), respectively.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Target population: Healthy (current non-smokers) subjects as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory determinations.
3. Subjects with body mass index of 18 to 32 kg/m2, inclusive
4. Men, and women of nonchildbearing potential. Women must have documented proof that they are not of childbearing potential and must not be breastfeeding.
5. Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of the study drug (3 days) plus 90 days (duration of sperm turnover) for a total of 93 days (approximately 14 weeks) after treatment completion. Female partners of male subjects are expected to use one of the highly effective methods of contraception listed in the protocol.

Exclusion Criteria:

1. History of any chronic or acute illness, recent infection, gastrointestinal disease, smoking and alcohol abuse, any significant drug allergy or allergy to digoxin, flurbiprofen, midazolam, omeprazole, or montelukast, Bruton's tyrosine kinase (BTK) inhibitors, immunologic or related compounds.
2. History of billiary disorder, asthma, bleeding disorder, cancer
3. Received live vaccine during last 12 weeks, active tuberculosis (TB) in last 3 years
4. Medical history indicative of an increased risk of arrhythmia.
5. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
The Role of Resistance Exercise in Chronic Obstructive Pulmonary Disease Exacerbation

The purpose of this study is to determine whether resistance exercise are effective in combating the decline in muscle strength during an exacerbation of Chronic Obstructive Pulmonary Disease (COPD).

Acute exacerbations are common in patients with COPD and cause specific signs and symptoms, such as increased dyspnea, productive cough with altered sputum, and fever. With disease progression, exacerbations are frequent and have a negative impact on health related quality of life and pulmonary function as well as increase mortality. More severe exacerbations require hospitalization resulting in enormous health expenditures, severely reducing daily life activities and declining peripheral muscle strength that can be only partially reversed after 3 months. Despite many features have been pointed out as responsible for the decrease in muscle strength during hospitalization, physical inactivity seems the most important.

Resistance training is an interesting therapeutic option to prevent and/or reverse muscular dysfunction due to immobilised in healthy subjects and stable COPD patients because induces hypertrophy of type II fibers, increases muscle strength and exercise tolerance. In addition, provokes lower dyspnea perception during effort compared with other exercise training. Despite these benefits for stable COPD, the impact of a resistance exercise program during hospitalization remains poorly known.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized for exacerbation of COPD

Exclusion Criteria:

* patients presenting change in mental status (confusion, lethargy or coma)
* persistence or worsening in hypoxemia (PaO2\<40mmHg) and/or respiratory acidosis (pH\<7.25) despite oxygen supplementation or use of non-invasive ventilation
* hemodynamic instability requiring vasoactive drugs
* patients transferred to ICU
* hospitalization lower than 5 days
* diseases that prevented the exercises
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis

The purpose of this research study is to gather scientific information about the effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult subjects with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ages 18 to 65 years
* A diagnosis of atopic dermatitis (AD)
* An Investigator's Global Assessment (IGA) score of 2 or higher and AD affecting at least 5% of total Body Surface Area (BSA)
* Other than active AD, in good health with no medical condition that may jeopardize the safety of the subject or impact the validity of the study results
* Subjects must be practicing acceptable birth control methods

Exclusion Criteria:

* Taking systemic immunosuppressive therapy within 3 months prior to screening or systemic (cortico) steroid therapy within 4 weeks prior to screening
* Use of phototherapy or tanning beds within 6 weeks of screening
* Presence of a clinically significant disorder involving gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition, which will jeopardize the safety of the subject or impact the validity of the study results
* Female subjects who are pregnant or breastfeeding
Effect of Simvastatin Versus Calcium Hydroxide Intracanal Medications on Post-operative Pain and Interleukin 6 and 8

Comparing the effect of Simvastatin versus calcium hydroxide used as an intracanal medicament on Post-operative Pain and Total amount of IL-6 and IL-8 in Periapical Fluids of lower premolars in patients with Symptomatic Apical Periodontitis:

Lower premolars with symptomatic apical periodontitis will be selected according to the eligibility and exclusion criteria and patients are then randomized to receive treatment either using simvastatin or calcium hydroxide intracanal medication for 1 week. The endodontic treatment will be completed in two visits. Postoperative pain will be assessed using the Numerical Rating scale at 6, 12, 24, 48 hours post-instrumentation and at 6, 12, 24, 48 hours post-obturation. Periapical fluid sample will be collected immediately post-instrumentation and 1 week later pre-obturation. The periapical samples will be analyzed for total amounts of IL-6 and IL-8.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
* Lower single rooted premolars:

  * Presence of pain with percussion.
  * Widening in the periodontal membrane space or with small sized periapical radiolucency.
  * Diagnosed clinically with symptomatic apical periodontitis.
* Patients' acceptance to participate in the trial.
* Patients who can understand pain scale and can sign the informed consent

Exclusion Criteria:

* Medically compromised patients
* Pregnant women
* Patients who are allergic to non-steroidal anti-inflammatory drugs.
* Patients with two or more adjacent teeth requiring root canal therapy
* If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively.
* Patients reporting bruxism or clenching.
* Teeth associated with acute periapical abscess, swelling or a fistulous tract.
* Greater than grade I mobility or pocket depth greater than 5mm.
* Non restorable teeth.
* Immature teeth.
* Teeth with previous endodontic treatment.
* Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS

A prospective observational study using de-identified data from the Neonatal Network Research Database (NNRD) supplemented by additional information on dose, method of surfactant administration and dosing frequency to assess whether the dose and method of administration of surfactant given to preterm infants with respiratory distress syndrome (RDS) affects neonatal outcomes.

The rationale for this study is the clinical relevance of understanding whether surfactant dose affects neonatal outcomes in infants with RDS who are treated in the immediate postnatal period.

In a research environment, the dose of surfactant is rigorously controlled, usually administered at a dose of 100mg/kg or 200mg/kg. In clinical practice, clinicians more frequently follow the 'whole vial dosing' approach, where a full vial is given aiming to get as close as possible to the desired dose. Reasons for whole vial use include reduction of waste and administration of surfactant shortly after birth where an infant's weight is unknown. It is unclear whether whole vial dosing leads to under-dosing or over-dosing and whether either situation affects outcomes.

Information regarding the dose of surfactant delivered, and the method of administration, are not currently routinely recorded in the UK.

The primary objective of the study is to compare two dosing groups (100-130 mg/kg and 170-200 mg/kg) in terms of the proportions of infants who require mechanical ventilation within four days of birth.

Eligibility Criteria:
Inclusion Criteria:

* \<37 weeks gestational age Requiring surfactant for Respiratory Distress Syndrome Record of birth weight available Born after study initiation

Exclusion Criteria:

* 37 weeks gestation age or above Parental opt-out
Silver Nitrate Application and Topical Corticosteroids for Hypergranulation Tissue

This protocol describes a randomized, two arm clinical trial comparing two topical treatments in patients with hypergranulation tissue at gastrostomy tube sites. The subjects are randomized to either group 1or group 2 treatments:

Maximum duration of therapy is 4 weeks. However, the therapy may be discontinued anytime at the discretion of the investigator or if there is resolution of the of the hypergranulation tissue.


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients \<18
2. Evaluated for hypergranulation at the G-tube site
3. Inpatient and out-patient

Exclusion Criteria:

Children not meeting the above criteia
A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence)

The objectives of the study are to assess the feasibility, reach and preliminary efficacy of a brief intervention that trains Black men who have sex with men \[referred to as Index\] (a) to use home-based testing for HIV and sexually transmitted infections and (b) promote home-based testing to their peers and sexual partners.

Sexually transmitted infections (STIs) increase one's risk of HIV infection, are serious co-infections that affect HIV clinical outcomes, and remain a risk for individuals using PrEP. Self-testing methods address barriers to clinic-based testing by offering convenience and privacy and have been shown to be well accepted by MSM. Therefore, use of self-testing is a potential approach through which to improve HIV and STI testing rates in MSM. Internet-based distribution (herein: web-based) of STI self-test kits enables an individual to request sampling kits via a website, mail biological specimens (e.g. urethral swabs) to a laboratory for testing, and view test results through a web-based account. Web-based self-HIV oral testing enables an individual to request a test kit, collect an oral specimen, and receive results within 20 minutes. Despite these potential benefits and reports of willingness to use free self-testing, uptake has been low due to barriers such as concerns about accuracy of the tests, apprehension to collect specimens, low risk perception, and the desire for counseling. In the proposed study, investigators will pilot test an intervention that address these barriers by training BMSM with information about the accuracy of the HIV rapid oral test kit, demonstrating how to properly collect specimens for HIV and STIs (gonorrhea, chlamydia and syphilis) self-testing, and providing resources for linkage to HIV and STI treatment and PrEP services. Study participants will utilize a secure website to request test kits.

Eligibility Criteria:
Inclusion Criteria:

* self-report male sex
* condomless anal sex with \>1 male in the prior 6 months
* self-report Black race
* aged 18 or older
* internet use at least once a week.

Exclusion Criteria:

* younger than 17
NEAT - Prevention and Treatment of Overweight and Obesity.

This study will investigate the effect on Non-exercise Activity Thermogenesis (NEAT) when implementing active workstation at offices compared to conventional office work. The primary hypothesis is that this implementation will lead to a significant increase in time spent walking per day.

NEAT consists of the energy expenditure of the physical activities that are non sporting-like and that we perform in our everyday life, such as walking, cleaning, shoveling snow etc. Which occupation we have play a big role in how much we are able to active our NEAT during our days and those who have more active jobs can expend up to 1500kcal more per day than those with sedentary jobs.

This study aims to try and increase NEAT at offices where sedentary time often is high. Participants will be randomized to either an intervention group or to a control group. Participants in the control group will continue to work at their regular desk, but will receive an individual health talk in the beginning of the study where diet and physical activity recommendations will be discussed.Participants in the intervention group will receive the same individual health talk and a treadmill desk, which they will use for 12 months at self-selected speed. They will be recommended to walk on the treadmill for at least 1 hour per day.

Eligibility Criteria:
Inclusion Criteria:

* Office workers with mainly sedentary tasks
* BMI 25-40

Exclusion Criteria:

* Severe depression and/or anxiety
* Exhaustion disorder
* Diabetes Mellitus
* Severe cardiovascular disease
* Severe kidney disease
* Musculoskeletal disorders that prohibit walking on a treadmill
* Contraindications for physical activity
* Thyroidea illness
* Pregnancy

For fMRI-study, additional exclusion criteria are:

* Implanted metal- or electrical devices
* Pregnancy
* Extraneous metal pieces in the body
Pharmacokinetic and Exploratory Biomarker Study of ABT-126 in Healthy Volunteers

The objectives of this study are to determine the cerebrospinal fluid (CSF) levels of ABT-126 and to examine the effects of ABT-126 on exploratory biomarkers after administration of a single does of ABT-126 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects between 18 and 50 years of age

Exclusion Criteria:

* History of bleeding disorders or Deep Vein Thrombosis
* History of spinal surgery
* History of migraine headaches, or other types of headaches occuring more than 2 times per month, or history of spinal disc disease, or chronic, significant low back pain
Clinical Utility of Capnography in the PACU( Post-anaesthesia Care Unit)

Multi-center observational trial with study device blinded in order to assess in parallel standard monitoring and intervention practices related to management of respiratory compromise in the post-anaesthesia care unit (PACU)

All Study device information is blinded to medical staff but the Study Coordinator will have full access to device measurements, alarms, notification and events via a local Wi-Fi hub sent to a portable tablet. The tablet Case Report Form (CRF) will allow all observation be inserted with a time stamp on the electronic device data. In addition, all electronic data will be collected from the bedside monitor.

Eligibility Criteria:
Inclusion Criteria:

1. Adult ≥ 18 years of age
2. ASA Score II - IV (American Society of Anaesthesiologists Score)
3. Patients booked for a surgical procedure requiring general anesthesia care
4. Expected duration of general anesthesia to be \> 1.5 hours
5. Expected to receive intraoperative opioids
6. Expected to be transferred to the PACU from the operating room
7. Patients with an expected duration in the PACU ≥ 45 minutes
8. Expected to be transferred from the PACU to an in-patient setting

Exclusion Criteria:

1. Patients expected to be discharged from the hospital when discharged from the PACU
2. Subjects who will have oral/nasal surgery that may prevent wearing an oral/nasal capnography sampling filterline.
3. Subjects with a history of severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors.
4. Patients with skin lesions or physical deformities that would prevent the application of finger sensors for optimal performance.
5. A female known to be pregnant.
REVOLVE or PureGraft Technique in Processing Fat Grafts for Patients Undergoing Breast Reconstruction

This trial studies how well REVOLVE or PureGraft technique works in processing fat grafts for patients who are undergoing breast reconstruction. During breast reconstructive surgery that uses autologous fat grafting (transplanting fat tissue from one part of your body to another), fat tissue is removed from the body (usually the abdomen, buttock, or thighs) and injected into another part of the body. This tissue must be "processed" (sometimes referred to as "washed" or "prepared") before being inserted back into the body. It is not yet known whether REVOLVE or PureGraft technique may work better in retaining graft fat after surgery.

PRIMARY OBJECTIVES:

I. To measure and compare the rate of fat graft retention, defined as the rate between the volume of fat remaining in the surgical site at one year and the volume of fat at baseline, associated with the use of two aforementioned adipose tissue processing techniques.

SECONDARY OBJECTIVES:

I. To measure early post-operative complications including infection, hematoma, delayed wound healing or seroma.

II. To measure late complications associated with fat grafting including fat necrosis, cyst formation, palpable mass, or breast asymmetry.

III. To measure patient reported outcomes (PRO, BREAST-Questionnaire \[Q\], Body Image Survey).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo reconstructive surgery with REVOLVE technique.

ARM II: Patients undergo reconstructive surgery with PureGraft technique.

After completion of study, patients are followed up at 2-4 weeks and then once a year for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Previous breast surgery, either mastectomy or partial mastectomy
* Patients with available harvest sites for fat grafting
* Patients with body mass index (BMI) \> 20
* Anticipated harvested fat volume \> 100 cc
* Patients are willing and able to give consent

Exclusion Criteria:

* Patients with active cancer, including primary cancer, recurrent cancer and locally or distantly metastatic cancer
* Patients who are unable to provide consent
* Patients who are suspected or known to be pregnant
Conservative Treatment of Distal Radius Fracture in Elderly in Randomized Controlled Trial

There is no consensus about the best conservative treatment for patients with dorsally displaced distal radius fractures. The previous studies that have examined the most valid method for cast immobilization have lacked uniform and patient-rated outcome measures, proper randomization and sufficient study population. The aim of this study is to compare functional position cast to flexion-ulnar -deviation with dorsally displaced distal radius fractures in patients aged 65 years or older. The conservative treatment is performed in clinical practice by various health care professionals with different techniques of reduction which are not limited to any specific technique in this pragmatic, randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Low energy intra- or extra-articular dorsal primarily stable, reducible DRF within 3 cm of the radiocarpal joint diagnosed with lateral and posterior-anterior radiographs in ER
* Physician on-call (general practitioner, acute physician, orthopedic resident, orthopedic consult) thinks patient could be appropriate for non-operative treatment

Exclusion Criteria:

* Operative treatment
* Refuse to participate the study
* Open fracture more than Gustilo 1 gradus
* Age under 65 years
* Chauffeure's or Barton´s fracture
* Smith´s fracture (volar angulation of the fracture)
* Does not understand written and spoken guidance in local languages
* Pathological fracture or previous fracture in the same wrist, forearm or elbow