cyrilzakka/clinical-trials huggingface dataset:
Alcohol After Bariatric Surgery 2

The goal of this observational study is to learn how the body processes ingested alcohol and how alcohol affects mood and blood sugar in both men and women after undergoing sleeve gastrectomy. The main question\[s\]it aims to answer are:

* Are there differences in the way that ingested alcohol is handled in men versus women after sleeve gastrectomy?
* What is the consequence of drinking alcohol on an empty stomach versus after a meal on blood sugar control after undergoing sleeve gastrectomy?

Participants will participate in two types of alcohol tests (alcohol given orally or administered intravenously) after not eating anything overnight or after having a meal.

Researchers will compare men and women who underwent sleeve gastrectomy with men and women who had no surgery, are of similar age and body composition, and have similar alcohol intake patterns.

The primary goal of the proposed study is to determine sex-related differences in the impact of Sleeve Gastrectomy (SG) on the pharmacokinetics (Aim 1), subjective effects (Aim 2), and glycemic effects (Aim 3) in the fasted versus prandial state when alcohol is ingested or given intravenously clamped (the gold standard to measure alcohol elimination rate and acute alcohol tolerance). We will use a cross-sectional study to compare participants who underwent SG surgery 1-5 years ago with matched non-operated controls (both sexes). This project will answer the questions of whether there are sex-related differences in the impact of SG on alcohol's pharmacokinetics and pharmacologic effects, whether drinking alcohol with a meal is effective post-SG, and clarify the site of alcohol first-pass metabolism in men. Findings from this study will contribute to evidence-based recommendations on the impact of SG on alcohol-related toxic effects and could help expand the knowledge base of sex-related differences in human alcohol pharmacokinetics.

Eligibility Criteria:
Inclusion Criteria:

* Surgery groups:

  * Male and female, 21-64 yrs. of age
  * Drink at least 1 standard drink per month but no more than 7 per week (women or \> 14 for men)
  * Underwent SG surgery 1-5 years ago

Non-surgery control group

* Male and female who did not undergo bariatric surgery
* Age , BMI, race , and alcohol pattern of consumption equivalent to participants in the SG surgery groups

Exclusion Criteria:

* For all groups (surgery and non-surgery groups)

  * Smoking or having quit smoking less than 2 months ago
  * Pregnant or breastfeeding
  * Taking any medications that might affect alcohol metabolism
  * Anemia
  * Gastritis, colitis, Crohn's Disease, malabsorptive diseases, inflammatory diseases, liver disease, kidney disease, cancer less than five years ago, stroke, or severe organ dysfunction
  * Body weight \>450 pounds (because of a limit on body composition machine)
  * Alcohol use disorder
  * Regular use of drugs with addiction potential or regular misuse of substances
  * Abnormality on EKG as determined by a study physician to present a safety risk
Comparing Imaginal Exposure and Imagery Rescripting in Treatment of Posttraumatic Stress Disorder (PTSD)

The outcome of trauma treatment (Posttraumatic Stress Disorder - PTSD) may be influenced by which emotions that are predominant among current symptoms, e.g. fear, anger, guilt, shame. Different treatment procedures for processing traumatic memories may resolve different emotions. This study compares two different treatment procedures of working with trauma memories in PTSD treatment (namely, Imaginal Exposure and Imagery Rescripting) in order to test this.

The main objectives of this study are:

1. To assess the relative efficacy of the two procedures in inpatient treatment for PTSD
2. To assess whether the predominant emotions in the traumatic memories moderate the outcome of the different procedures
3. To assess whether theory-derived constructs mediate outcome and whether the mediating relationships are different in the two treatments
4. To provide a theoretical account of the two models
5. To psychometrically evaluate 3 new measures

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of PTSD identified as primary diagnosis
* Accepts withdrawal of all psychotropic medication

Exclusion Criteria:

* Extensive dissociative symptoms or current psychosis,
* Current suicidal risk,
* Extensive current substance or alcohol abuse, or
* Ongoing trauma
Online Pivotal Response Treatment Training in Autism Spectrum Disorder

This is a research study that will assess the effects of a Pivotal Response Treatment Online Training Course (PRT-O) for training parents of children with Autism Spectrum Disorder (ASD). The study will specifically investigate whether participants can learn to deliver PRT effectively following participation in the Online training.


Eligibility Criteria:
Inclusion Criteria:

* 2:0 to 5:11 years at the time of consent,
* diagnosed with ASD (based on history, review of available medical records including diagnostic testing, e.g., Autism Diagnostic Observation Schedule) or suspicion of Autism Spectrum Disorder diagnosis, and confirmed with Autism Diagnostic Interview-Revised (ADI-R),
* with significant adaptive communication deficits (i.e., either a Vineland-3 Communication subscale 2 Standard Deviations below average for 2 and 3 year olds and 3 Standard Deviations below for 4 and 5 year olds or a Vineland-3 Expressive V-scale Score 2 Standard Deviations below average for 2 and 3 year olds, or 3 Standard Deviations below for 4 and 5 year old, and at least moderate severity on the Clinical Global Impressions Severity (CGI-S) language subscale),
* an English-speaking parent able to consistently participate in study procedures and conduct treatment in English,
* stable psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation,
* stable treatment (ABA, Floortime, or other interventions), speech therapy, and school placement for at least 1 month prior to baseline measurements with no expected changes during study participation,
* no more than 60 minutes of 1:1 speech therapy per week

Exclusion Criteria:

* Children who have a primary language other than English
* parent or child diagnosed with severe psychiatric disorder or unstable medical problem
* previous adequate trial of pivotal response treatment resulting in parent meeting Pivotal Response Treatment fidelity of implementation at baseline
* Receiving more than 15 hours of in home 1:1 ABA per week
Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)?

The investigators would like to determine if there are patients with PPI responsive Eosinophilic Esophagitis Infiltration that have significant loss of esophageal distensibility suggestive of esophageal fibrosis typical of classic Eosniophilic Esophagitis.

If this group of patients exists, the investigators would like to determine if they have the typical endoscopic features of EoE rather than those of GERD.


Eligibility Criteria:
Inclusion criteria:

* Age 18 or older
* Have either mild-to-moderate Los Angeles (LA) Classification System grade B, moderately severe LA grade C, or severe LA grade D erosive reflux esophagitis
* Or patients having a clinically indicated pH/impedance monitoring on proton pump inhibitor therapy for indications of gastroesophageal reflux disease.

Exclusion criteria:

* Neoplasm of the esophagus or stomach
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
* Disorders which predispose to unreliable responses such as Schizophrenia, Alzheimer's disease or significant memory loss
Effect of Expiratory Positive Pressure on Dynamic Hyperinflation and Ability to Exercise With Upper Limbs in COPD

The study will evaluate the effect of positive airway expiratory pressure (EPAP) on patients with chronic obstructive pulmonary disease (COPD) during submaximal upper limb exercise.

The study to be developed from this project aims to evaluate the effect of positive airway expiratory pressure (EPAP) on upper limb exercise-induced dynamic hyperinflation (DH) in patients with chronic obstructive pulmonary disease (COPD). To this end, a cross-over study will be implemented, developed at the Pulmonology Department of Hospital de Clínicas de Porto Alegre. Patients with moderate to very severe, clinically stable COPD will be evaluated. The anthropometric data and pulmonary function will be collected from the medical records, being the study divided into two stages. First stage: At the first visit, dyspnea, quality of life will be evaluated and a maximal incremental cardiopulmonary exercise test (CPET) for upper limb with DH evaluation during exercise. Patients who presented DH on incremental CPET will be invited to return for a second and third visit. In the second and third visit an endurance test will be performed with 80% of the load reached in the incremental CPET and DH determination, one of the tests performed during the application of EPAP through a face mask with pressure level Of 10 cmH2O and another in usual breathing, with the mask without the use of the positive pressure generating valve. The sequence of the test, ie, with and without EPAP, will be obtained through electronic randomization. Patients completing stage 1 will be invited to enter step 2. In this step, which will occur in a single visit, patients will perform a 6-minute pegboard and ring test (6PBRT) with The same monitoring of CPET in three different situations, according to randomization: habitual breathing, half-closed lip breathing (RLS) and the EPAP mask. Thus, it is expected that the application of EPAP through face mask and the use of RLS will reduce DH during submaximal exercise with upper limb, which will be associated with the reduction of dyspnea and increased tolerance to exercise in COPD patients .

Eligibility Criteria:
Inclusion Criteria:

* clinical disease stability (no signs of exacerbation within 8 weeks prior to enrollment)
* receiving standard long-term bronchodilator (BD) therapy
* able to perform cycle ergometer exercise for upper limbs

Exclusion Criteria:

* use artificial airways
* severe comorbidities, such as heart, orthopedic or neurological diseases that are risky or make it impossible to exercise
* Patients on oxygen or with indication of continuous home oxygen therapy
Efficacy of Ozone Gel, Doxycycline Saturated Chitosan Dressing Versus Alveogyl

Efficacy of ozone gel, doxycycline saturated chitosan dressing versus Alveogyl in pain alleviation and healing of alveolar osteitis in diabetic patients


Eligibility Criteria:
Inclusion Criteria:

* Patients over 20 years and under 60 years of age
* DM controlled by medication, presented to outpatient clinic with signs and symptoms of dry socket
* Only participant that are willing to control and record blood glucose level throughout the study period

Exclusion Criteria:

* Patients with any significant medical condition (besides DM)
* Alcoholic individuals
* Patients on drugs that affect the central nervous systems
* Patients who reported the use of drugs that might interfere with pain sensitivity
* Pregnant and lactating women
* Hypersensitivity to local anesthetics
The Effect of Cold Application on Pain Level, Edema and Drainage Amount

In this study, we aimed to investigate the effect of cold application applied for 20 minutes every hour for 8 hours on the first day, second and third days after total hip arthroplasty with gel pads, on the pain level, edema and drainage amount of total hip arthroplasty patients. The main question\[s\]it aims to answer are:

* Is there a difference between the pain levels of patients in the control and cold application arms?
* Is there a difference between the knee edema of patients in the control and cold application arms?
* Is there a difference between the amount of drainage of patients in the control and cold application arms? This study was planned as a prospective, parallel, two-arm (1:1) randomized controlled trial (RCT).

* When the patient arrives at the service after TKA, cold application will begin with gel pads at 0 ºC and continue for eight hours. After TKA, cold application will continue for 20 minutes every hour between 08.00-16.00 on the 1st and 2nd day.
* After TKA, pain intensity will be evaluated and at the 6th, 24th and 48th hours.
* Knee circumference measurements for knee edema will be made before TKA and at the 24th and 48th hours after TKA.
* After being taken to bed after TKA, the amount of drainage will be measured at the 1st, 6th and 24th hours.
* In the first 24 hours and 24-48 hours after TKA. Analgesic consumption between hours will be recorded.
* Knee temperature will be measured before and after each cold application.
* Knee temperature will be measured before and after each cold application. Measurements of the control group will be made at the specified times in the cold application group. Cold application will not be applied to the control group.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and above,
* Able to communicate verbally and in writing,
* Turkish speaking,
* TKA applied for the first time,
* Unilateral total knee arthroplasty applied,
* Spinal anesthesia applied,
* Having a hemovac drainage catheter,
* Without peripheral vascular disease,

Exclusion Criteria:

* Revision total knee arthroplasty applied,
* Bilateraltotal knee arthroplasty applied,
* Those who use alcohol and substances,
* TKA was performed for a reason other than knee osteoarthritis,
* General anesthesia applied,
Rhythmic Estradiol and Bone Health

The goal of this randomized-controlled trial is to compare the effect of rhythmic estrogen treatment to continuous estrogen treatment on bone turnover in healthy postmenopausal women. The main question it aims to answer are:

• Does rhythmic estrogen lead to increased bone formation in healthy postmenopausal women, compared to continuous estrogen?

Participants will receive one of the following treatments for a duration of 16 weeks:

- Rhythmic estradiol: Alternating 4-week cycles consisting of transdermal 17-β-estradiol 25μg/24hrs for two weeks, followed by two weeks of transdermal 17-β-estradiol 50μg/24hrs. Estradiol therapy will be combined with continuous oral micronized progesterone 100mg once daily.

* Low-dose continuous estradiol: Continuous transdermal 17-β-estradiol 25μg/24hrs, combined with continuous oral micronized progesterone 100mg daily once daily.
* Standard-dose continuous estradiol: Continuous transdermal 17-β-estradiol 50μg/24hrs, combined with continuous oral micronized progesterone 100mg daily once daily.

If there is a comparison group: Researchers will compare rhythmic estradiol to continuous estradiol to see if rhythmic estradiol improves bone formation in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal, defined as final menstrual cycle more than 1 years prior to inclusion and FSH\>30 IU/L
* Final menstrual cycle \< 10 years prior to inclusion

Exclusion Criteria:

* Contra-indication for estrogen and/or progesterone therapy
* First-grade family member with inherited thrombophilia or history of venous thromboembolism under the age of 60 years
* Hysterectomy
* Premature menopause (menopause age \<40 years)
* Known hypersensitivity to the excipients in the estradiol patch or progesterone capsule
* Hormonal contraception or hormone replacement therapy use (estradiol with or without progesterone) in the past 12 months
* Presence or history of any clinically relevant metabolic, endocrinological, hepatic, renal, cardiovascular, gastrointestinal, or respiratory conditions, history of bone disease or bone marrow disease, known vitamin D deficiency (25-OH vitamin D \<30 nmol/L)
* Recent fracture (\<12 months)
* BMI \<20 or BMI ≥30
* Use of drugs including herbal medicine known to affect bone metabolism (e.g. corticosteroids) or to interfere with cytochrome P450 enzyme (CYP) pathways. Exceptions are occasional use of paracetamol, ibuprofen, acetylsalicylic acid or topical medication
Early Detection of Neuropathy in ATTRv

The purpose of the study is to evaluate and compare different tools that are used to detect evidence of peripheral neuropathy in patients with TTRv.

Early detection of peripheral neuropathy in patients with TTRv is important to support initiation of therapy that alters the course of the disease. Current tools used to detect peripheral neuropathy may not be sensitive, especially in very early and distal peripheral neuropathy. This study will compare different methods of assessing for peripheral neuropathy including using in-vivo reflectance confocal microscopy to assess for meissner corpuscles, serum neurofilament light chain, quantitative sensory testing, neuropathy impairement scores, nerve conduction studies and quality of life and symptoms questionnaires.

Eligibility Criteria:
Inclusion Criteria:

Patients with known TTR mutations and neuropathy

1. Patients with TTR mutation and no symptoms within less than 10 years of typical onset of disease
2. Age criteria must meet the following:

   * Non V122I mutations, Age 40 or older.
   * V122 I mutations, 55 or older.

Healthy persons without neuropathy

1. The following distribution of age ranges will be considered when enrolling healthy participants:

   * 5 patients age 30-40
   * 5 patients age 40-50
   * 5 patients age 50-60
   * 5 patients age 60-70
2. Healthy control subjects for this study are defined as subjects with no symptoms of neuropathy or risk factors for neuropathy such as family history of hereditary neuropathy, chemotherapy, diabetes, autoimmune disease, or vitamin deficiency. Their status will be verified by medical records review.

Exclusion Criteria:

1. Patients with neuropathy other than TTR amyloid
2. Subjects with risk factors for neuropathy (diabetes, history of neuropathy in the family, neurotoxic drugs) or with neurological disorder associated with elevated NFL
Federal Study of Adherence to Medications in the Elderly (FAME)

The purpose of this study is to determine the effect of a comprehensive pharmacy care program on medication adherence and persistence, blood pressure, and LDL cholesterol.

Poor medication adherence is prevalent, difficult to manage, and diminishes the health benefits of pharmacotherapies. Elderly patients with coronary risk factors frequently require treatment with multiple medications which places them at increased risk for medication nonadherence. Effective strategies to improve adherence in the elderly are lacking, and improved health outcomes in this population have not been demonstrated.

Objective: We tested the efficacy of a comprehensive pharmacy care program including patient education and an adherence aid (medications custom-packaged in blister packs) to improve medication adherence and its associated effects on blood pressure and low density lipoprotein cholesterol.

This is a Multi-phase, prospective observational and randomized controlled trial. We enrolled community-based patients aged ≥ 65 years old taking ≥ 4 chronic medications per day.

Intervention: After a 2-month run-in phase during which baseline medication adherence (via pill counts), blood pressure, and low-density lipoprotein cholesterol were measured, participants entered a 6-month intervention phase during which standardized medication education and regular follow-up by a clinical pharmacist was provided and medications were dispensed in daily, time-specific blister packs. Following the intervention phase, participants were randomized to continued pharmacy care/blister packs versus usual care (return to their original method of medication administration) for an additional 6 months.

Main Outcome Measures: The primary endpoint of the observation phase was the change in the proportion of pills taken compared to baseline; secondary endpoints were the associated changes in low-density lipoprotein cholesterol and blood pressure. The primary endpoint of the randomized trial was the between-group comparison of medication persistence analyzed according to intention to treat.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or older taking 4 or more chronic medications independently living

Exclusion Criteria:

* assisted living or nursing home residents presence of any serious medical condition for which 1-year survival was expected to be unlikely
A Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of HS-10383

This study will investigate the safety, tolerability and pharmacokinetics of ascending multiple doses of HS-10383 in healthy subjects using a randomized, double blind, placebo controlled, single center study design.

HS-10383 is a selective P2X3 receptor antagonist being developed for the treatment of refractory/unexplained chronic cough. This Phase 1b study will investigate the safety, tolerability and pharmacokinetics of ascending multiple doses of HS-10383 administered orally to healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy participants aged from 18 to 45 years
2. Subjects need to fully understand the research content and process, as well as possible adverse reactions, and voluntarily sign the informed consent;
3. Male weight ≥ 50kg, female weight ≥ 45kg, body mass index {BMI, BMI=weight/height 2 (kg/m2)} is controlled within the range of 18\~26 (including the critical value);

Exclusion Criteria:

1. The following medical histories, such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, metabolic endocrine system, skin disease, blood system, immune system and tumor, etc., were screened. evaluated as unsuitable to participate in this study;
2. Any known presence or history of hypogeusia, abnormal taste or dysgeusia;
3. Any known presence or history of severe allergies, or known to be allergic to the components of the test drug;
4. Use of any drugs, including prescription drugs, over-the-counter drugs or herbal preparations, cannot be avoided or expected to start 2 weeks (or 5 half-lives) before screening and throughout the study period;
5. Any findings of electrocardiogram outside from normal, such as the QT interval (QTcF) corrected by the Fridericia formula, the absolute value of QTcF for males is \>450 ms, and the absolute value of QTcF for females is \>470 ms;
6. Any findings of blood pressure or pulse in resting state outside from normal a: such as systolic blood pressure \<90 mmHg or ≥140 mmHg, diastolic blood pressure \<60 mmHg or ≥90 mmHg, pulse \<55 bpm or \>100 bpm;