cyrilzakka/clinical-trials huggingface dataset:
N-Acetylcysteine for Adolescent Alcohol Use Disorder

This is a 8-week randomized, placebo-controlled trial testing the effects of N-acetylcysteine (NAC), on a platform of weekly evidence-based brief alcohol intervention for 120 adolescents with alcohol use disorder (AUD). The primary efficacy endpoint is reduction in alcohol use (total standard drinks), compared between NAC and placebo groups.

Adolescence is a critical developmental stage involving marked elevation in alcohol initiation, progression to AUD, and development of significant, lasting adverse outcomes from use. Effective treatments must be developed for AUD in this especially vulnerable age range. The identification of a well-tolerated, effective pharmacological treatment would represent a significant advance and could yield tremendous public health impact. The proposed trial will provide critical data to evaluate NAC as a highly promising pharmacotherapy for adolescent AUD, and regardless of NAC versus placebo outcomes will provide key methodological guidance for future randomized controlled trials of pharmacotherapies for adolescent AUD. Randomized participants will be provided and instructed to take their assigned medication at 1200 mg twice daily, in approximately twelve-hour intervals.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is 13-25
2. Must be able to understand the study and provide written informed consent (for participants under 18 years old, a parent/legal guardian must be able to provide consent and the participant must be able to provide assent).
3. Current moderate to heavy drinker by established adolescent criteria
4. Meet criteria for alcohol use disorder
5. Females must agree to use appropriate birth control methods during study participation: oral contraceptives, contraceptive patch, barrier (diaphragm or condom), levonorgestrel implant, medroxyprogesterone acetate, complete abstinence from sexual intercourse, or hormonal contraceptive vaginal ring

Exclusion Criteria:

1. Score \>10 on the Clinical Institute Withdrawal Assessment for Alcohol
2. Allergy or intolerance to N-acetylcysteine
3. Females who are pregnant, contemplating pregnancy or lactating over the next 6 months
4. Current use of N-acetylcysteine or any supplement containing N-acetylcysteine (must agree not to take any such supplement throughout study participation)
5. Current enrollment in treatment for alcohol use disorder or expectation of other treatment during protocol participation
6. Any other medical or psychiatric condition or other significant concern that in the Investigator's opinion would impact participant safety or compliance with study instructions, or potentially cofound the interpretation of findings
Dissonance Eating Disorder Prevention: Clinician Led, Peer Led vs Web Delivered

Five percent of young women meet criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder, with another 5% meeting criteria for Eating Disorder Not Otherwise Specified (ED-NOS), which includes subthreshold variants of these disorders. Over half of those presenting for eating disorder treatment meet criteria for ED-NOS and both threshold cases and ED-NOS are marked by chronicity, relapse, distress, functional impairment, and increased risk for future obesity, depression, suicide attempts, anxiety disorders, substance abuse, morbidity, and mortality. Anorexia and bulimia nervosa show stronger relations to suicide attempts, outpatient/inpatient treatment, and functional impairment than most other psychiatric disorders. Treatment of eating disorders is very expensive, similar to the cost for schizophrenia treatment, and is effective for only 40-60% of patients. Thus, a public health priority is to develop and disseminate effective eating disorder prevention programs.

Although dozens of eating disorder prevention programs have been evaluated, only a dissonance-based program (the Body Project) has significantly reduced future onset of threshold and subthreshold eating disorders through long-term follow-up. An effectiveness trial found that the Body Project produced significant reductions in risk factors, eating disorder symptoms, and functional impairment relative to educational brochure controls, with some effects persisting through 3-yr follow-up when high school clinicians recruited students and delivered the program. These trials confirm the efficacy and effectiveness of the Body Project, but revealed a key dissemination barrier; it can be difficult to identify and recruit clinicians at high schools and colleges with the time and expertise to competently deliver the program.

One solution to this key dissemination barrier is to train students in established peer leader programs at colleges to recruit high-risk students and deliver the program. Another solution to this dissemination barrier would be to deliver the Body Project via the Internet.

Because peer-led groups and Internet delivery of the Body Project could markedly extend the reach and sustainability of this evidence-based program, we propose to conduct the first large multi-site effectiveness trial that directly compares the effects and cost effectiveness of peer-led Body Project groups, the eBody Project intervention, and clinician-led Body Project groups to an educational video control condition.

Eligibility Criteria:
Inclusion Criteria:

* Body image concerns
* Attend University of Oregon, Oregon State University, University of Texas at Austin, or Southwestern University

Exclusion Criteria:

* Meeting criteria for anorexia nervosa, bulimia nervosa, or binge eating disorder
* Suicidal ideation
Therapeutic Rainforest Study in Generating Positive Energy Among Undergraduate Students

This study looked into how therapeutic forest walking will impact the well-being of undergraduate students at the National University of Singapore. A three-arm randomized control trial on 108 participants is being planned for this study. The primary aim of this study is to assess the feasibility and primary effect of the Therapeutic Rainforest Walking in generating positive energy among undergraduate students project in enhancing the quality of life, physical, mental, and psycho-social well-being among University students.


Eligibility Criteria:
Inclusion Criteria:

* Current NUS undergraduate students
* No self-reported physical mobility issue
* No self-reported existing mental health conditions
* Enjoys nature

Exclusion Criteria:

-
Effects of TBE VS GE on Scapular Dyskinesia in Male Cricketers.

We wanted to find the effectiveness between the theraband and general exercises on scapular dyskinesis in male cricket players.

Cricket game is considered a non-contact low-injury risk sport associated to other sports, chronic and acute traumatic injuries are the two common types of injury mechanisms. Theraband exercises are those exercises which are considered as a safe tool which increases the functional ability and muscle strength. Scapular dyskinesis (which is called as sick scapula) as commonly defined as an alteration or deviation in the resting position or during movable position of the scapula during shoulder joint motions. A study reported that Theraband exercises increase the function of the muscles. These muscles participate to the strength of the shoulder girdle, stability and mobility. Theraband exercises are considered to be able increase the proprioception and balance. The prevalence of scapular dyskinesia (74.6%) dominant side scapula turns medially, inferiorly, and also tilts anteriorly as relate to non-dominant side shoulder blade.Scapular dyskinesia has been more determined in healthy individuals but statics has also mentioned that scapular dyskinesia a greater prevalence in overhead (61%) than non-overhead sportspersons (33%). Maximum cricket players complain that they feel discomfort in the scapular region. Because occasionally the scapular dyskinesia causes the discomfort in scapula region and it is due to the muscles weakness of the scapula. It is mostly occur in overhead athletes because of the constant repetitions of the shoulder movement over the head. For intervention purpose in scapular dyskinesia, cricket players maximum concentrate on general exercises instead of theraband exercises because they don't aware about the effectiveness of theraband exercises in this condition and theraband exercises involve using resistance bands of varying strengths to perform specific movements targeting the muscles around the scapula. These exercises could help improve the muscle strength, endurance, and control, which will be essential for stabilizing the scapula and improving its movement patterns while general exercises improve the overall functional movement patterns, which may indirectly benefit scapular dyskinesia by strengthening surrounding muscles and improving overall shoulder mechanics. Despite up to my searched no study has been found about it so this study is designed to find the effectiveness of thera-band exercises on scapular dyskinesia in male cricketers.

Eligibility Criteria:
Inclusion Criteria:

* • Scapular dyskinesia type I

  * Only male cricketers.
  * Age from 18 to 30 years old.
  * Training at least 4 times per week and 10 hours weekly training.
  * Male cricket players playing since last one year.

Exclusion Criteria:

* • The history of scapular fracture repair surgery and neck surgery during previous 12 months.

  * The players that are out of practice from 5 weeks.
  * Traumatic history of cervical region and scapula.
  * Serious pathologies regarding shoulder, cervical and scapula.
  * Female cricketers
Comparison of CHS-0214 to Enbrel (Etanercept) in Patients With Chronic Plaque Psoriasis (PsO)

This is a two part study comparing CHS-0214 to Enbrel in patients with chronic plaque PsO who have not yet received any biologic therapy for any indication (other than insulin or hormones).

Pt. 1 is a 12-week randomized, double-blind, active-control, parallel-group, multi-center global study. The primary end point is 75% improvement from baseline according to the Psoriasis Area and Severity Index (PASI-75). Comparing CHS-0214 to Enbrel for efficacy and safety at a dosage of 50mg subcutaneous (Sc) twice weekly.

Pt. 2 is a 40-week randomized, double-blind, active-control, parallel-group, multi-center global study where CHS-0214 and Enbrel dosage is reduced to 50mg Sc weekly for maintenance.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults
* PsO diagnosis for 6 months
* Active disease: PASI greater than or equal to 12, Physician's Static Global Assessment (PSGA) score greater than or equal to 3 (based on a scale or 0-5),
* Body Surface Area (BSA) involved with PsO greater than or equal to 10%
* Dermatology Life Quality Index (DQLI) greater than or equal to 10
* Previously received phototherapy or systemic non-biologic therapy for PsO

Exclusion Criteria:

* Forms of Psoriasis other than PsO
* Drug induced Psoriasis
* Positive QuantiFERON-tuberculosis (TB) Gold Test
* Presence of significant comorbid conditions
* Chemistry and hematology values outside protocol specified range
* Major systemic infections
Efficacy and Safety Study of the Tolvaptan Tablets in Patients With Non-hypovolemic Non-acute Hyponatremia

This drug has been developed to treat Hyponatremia. The primary purpose of this study is to verify the efficacy and safety of seven-day repeated oral administration of tolvaptan at 15, 30, and 60 mg or placebo in patients with Non-hypovolemic Non-acute Hyponatremia secondary to Congestive Heart Failure (CHF), hepatic cirrhosis or Syndrome of Inappropriate Antidiuretic Hormone (SIADH), despite receiving standard therapy. This study is being conducted in China.


Eligibility Criteria:
Inclusion Criteria (for CHF):

1. Patients with CHF who exhibit edema, jugular venous distention, hepatomegaly, or pulmonary congestion.
2. Non-hypovolemic and Non-acute hyponatremia with a serum sodium \< 135mEq/L before randomization.
3. Patients who have taken furosemide at 40 mg/d or more (oral dosing) without alteration of dosage for the 3 days of the observation period.
4. Patients whose body weight has been stable (±1.0 kg) for 2 days prior to commencement of study drug administration.
5. Age:18～80 (when informed consent is obtained)，male or female.
6. In-patient subjects.
7. Informed consent.

Inclusion Criteria (for hepatic cirrhosis):

1. Patients with hepatic edema.
2. Non-hypovolemic and non acute hyponatremia with a serum sodium \< 135mEq/L before randomization.
3. Age:18～65 (when informed consent is obtained)，male or female.
4. In-patient subjects.
5. Informed consent.

Inclusion Criteria (for SIADH and others):

1. Patients with SIADH arising from a variety of etiologies.
2. Non-hypovolemic and non acute hyponatremia with a serum sodium \< 135mEq/L before randomization.
3. Age:18～80 (when informed consent is obtained)，male or female.
4. In-patient subjects.
5. Informed consent.
3DCRT vs. IMRT in Early Breast Cancer

It has been not clinically determined whether TomoDirect was dosimetrically better than 3D-CRT for Asian patients with early breast cancer. Therefore, the objective of this study was to compare dosimetric parameters of TomoDirect and 3D-CRT in early breast cancer patients of an Asian cohort.

In breast cancer patients, helical TomoTherapy is not a suitable option since the gantry continuously rotates around the patient, and this technique can deliver low dose radiation to lungs that is associated with an occurrence of radiation pneumonitis. To avoid this inefficiency of beam usage, a TomoDirect option using static gantry positions combined with simultaneous couch translation and dynamic collimator modulation has been developed. In a pilot study, TomoDirect seemed particularly well suited for postoperative irradiation in breast cancer patients. TomoDirect achieved an optimal target volume coverage and coincident adequate normal tissue sparing in a dosimetric study. Clinical studies of TomoDirect in breast cancer patients are scarce and have been assessed only in small and retrospective series. Thus, we undertook a prospective study on the technical feasibility and toxicity of TomoDirect in breast cancer patients who received postoperative radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. histologically confirmed breast cancer after breast-conserving surgery
2. pT1-2N0
3. no evidence of distant metastasis
4. no previous malignancy
5. patient age, 20 - 80 years
6. Karnofsky performance score ≥ 70
7. adequate bone marrow, liver, and renal function (leucocytes \> 4,000/mm3, hemoglobin \> 10 g/dL, platelets \> 100,000/mm3; serum bilirubin \< 1.5 mg/dL, serum transaminase \< 2.5 times the upper normal limit; serum creatinine \< 1.5 mg/dL).
8. completion of scheduled chemotherapy

Exclusion Criteria:

1. carcinoma in situ of breast
2. distant metastasis
3. mastectomy
4. male
5. both breast cancer
Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)

This 12 week study will observe patients with and without systemic lupus erythematosus who have persistent antiphospholipid antibodies in the blood who are starting a medicine called hydroxychloroquine. It will measure if these patients have a change in a blood test called the annexin A5 resistance assay over that 12 week period.

Antiphospholipid Syndrome (APS) is an autoimmune disorder of blood clotting and pregnancy loss. It is associated with proteins called antiphospholipid antibodies (aPL) in the blood. Blood clotting in this disease occurs for several reasons; one reason involves the interaction of aPL with another protein found on the surface of the cells that line blood vessels (endothelial cells). This protein, called annexin A5 (AnxA5), forms a shield over the surface of these cells. The AnxA5 Resistance Assay is a blood test that can detect when there is a problem with the protective AnxA5 shield on endothelial cell surfaces.

This 12 week study will observe patients with persistent aPL in the blood who are starting a medicine called hydroxychloroquine (HCQ). The primary goal of the study is to compare results of the AnxA5 resistance assay from patients before they start taking HCQ and after they have taken it for 12 weeks to see if the results of the blood test change. Our secondary goal is to measure a variety of other blood tests before and after patients have started taking HCQ; these tests include D-dimer, Activated Protein C (APC) Resistance, and aPL titers/status (LA test, aCL ELISA, aß2GPI ELISA, and anti-Domain-I ß2GPI ELISA).

Eligibility Criteria:
Inclusion Criteria:

* age 18 to 65
* new HCQ (200-400 mg/day) treatment (for all but 5 of 10 control subjects - see below)
* persistently positive aPL

Selected Exclusion Criteria:

* Steroid use greater than or equal to the equivalent of prednisone 0.5 mg/kg/day at the time of enrollment
* Heparin use at the time of enrollment
* Any immunosuppressive drug use within 3 months prior to screening
* HCQ use within the past 6 months prior to screening visit
* Another antimalarial agent treatment,
* Pregnant women, minors, mentally disabled, prisoners
* Acute thrombosis within 2 weeks prior to screening
Results of the Application of the Clinical Pathway of Intensified Recovery Surgery for Adults in the Processes of Total Knee and Hip Replacement at the Maz Hospital

The investigators are going to study all the patients who have undergone surgery at the MAZ hospital from 2019 to the present for knee replacement and hip replacement. The investigators want to analyze the results to see if applying the RICA clinical pathway results are better.


Eligibility Criteria:
Inclusion Criteria:

* Adults, over 18 years old.
* Diagnosis of moderate-severe gonarthrosis or moderate-severe coxarthrosis.
* Patients who are operated by orthopedic surgeons at MAZ Hospital with knee or hip arthroplasty.
* Between January 2019 and June 2022.
* ASA I-II-III.

Exclusion Criteria:

* ASA IV.
* Minors.
Probiotics on Intestinal Inflammation in Cystic Fibrosis

Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI tracts is influenced by both genetic and environmental factors. Children with CF may harbor an abnormal intestinal microflora, because of altered Cystic fibrosis transmembrane conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes and acid suppressors). The investigators previously demonstrated that intestinal inflammation is highly frequent in CF children, being a major feature of intestinal involvement. In addition, specific probiotics significantly improved airway and GI inflammation in a preliminary trial. The aim of the study is to characterize intestinal and respiratory microflora in CF patients and to investigate the effects of daily Lactobacillus GG (LGG) supplementation on both GI and airway microflora and the eventual relationship between probiotic assumption and clinical and inflammation markers. The aim is to study the effect of microflora modification on intestinal and extraintestinal inflammation to eventually improve the quality of life of CF patients, who often suffer from intestinal and respiratory progressive disease, through a non invasive intervention consisting in the supplementation of probiotic bacteria.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF documented by sweat chloride test over 60 mmol/L and confirmed by genotype analysis with the presence of F508del/F508del or F508del/other;
* Boys and girls between 2 and 16 years of age;
* Clinical stability at enrolment, defined as no clinical evidence of acute exacerbation, no modifications in the therapeutic regimen and no hospitalization in the last 2 weeks;
* Pancreatic insufficiency;
* Basal Forced expiratory volume 1 second (FEV1) above 50% of predicted value.

Exclusion Criteria

* Colonization of respiratory tract with Burkholderia cepacia spp.;
* Steroid therapy within one month before enrolment;
* Pregnancy and fertile women taking oral contraceptives;
* Parenteral or oral antibiotics therapy within 2 weeks before enrolment;
* Regular assumption of probiotics;
* Regular assumption of azythromycin.
Chronic Postoperative Pain After Laparoscopic Groin Hernia Repair

The study attempts to quantify the relative risks for chronic postoperative inguinal pain (CPIP) depending on different combinations of mesh and mesh fixation. For this purpose the investigators will analyze data from the Swedish Hernia Registry (SHR).

This is an open cohort study design where the investigators will analyze existing data that have been prospectively collected in the Swedish Hernia Registry (SHR), which covers \> 95% of all groin hernia repairs in Sweden. The very large cohort of approximately 25,000 primary TEP (totally extraperitoneal) and TAPP (transabdominal preperitoneal) repairs enable assessment of the relative risks for CPIP depending on different combinations of mesh and mesh fixation. Each participant was entered at the date of surgery when demographic and intraoperative data were registered. The possible presence of CPIP after 1 year postoperative was evaluated with a PROM questionnaire.

Eligibility Criteria:
Inclusion Criteria:

All laparoscopic TEP and TAPP repairs that have been registered in the SHR from September 1, 2012, until December 31, 2018.

Exclusion Criteria:

* Open repairs.
* Hernioplasties that were converted from laparoscopic to open surgery.
* Previous hernioplasty in the same groin
* Surgery merely for hernia (eg obturator) other than lateral, medial or femoral.
* Age \< 15 years.
* Patients not having a 10-digit state-assigned Patient Identification Number.
The Management of Glucose Control and Hypoglycemic Prevention Using Continuous Glucose Monitoring System in Patients With Type 1 Diabetes

This study was designed to evaluate the glucose control and hypoglycemic prevention effect of using continuous glucose monitoring system(CGMS) in patients with type 1 diabetes. This is a prospective randomized controlled, single-center clinical study. Patients will randomized 1:1 to either CGMS or conventional self-monitoring of blood glucose (SMBG) group. After 12 weeks of applying the CGMS sensors, the improvement of parameters collected from the CGMS will be estimated in comparison with data collected from the SMBG.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients ages \>= 20 years
2. Patients diagnosed with type 1 diabetes.
3. Patients with glycated hemoglobin (HbA1c) \> 8.0% within 6 months before screening
4. Patients who agree to perform self blood glucose monitoring responsibly during the study period
5. Patients diagnosed with type 1 diabetes minimum 3 months prior to recruitment

Exclusion Criteria:

1. Patients diagnosed with type 2 diabetes.
2. Patients with chronic disease (Excluding thyroid disorders in which thyroid function is controlled in the normal range), or psychiatric disease
3. Patients who cannot use the device properly such as an illiterate person or foreigners
4. Patients incapable of making decisions based on their own judgement and will
5. A person who may not participate in the study according to investigator's judgement