cyrilzakka/clinical-trials huggingface dataset:
Exercise Reset for Concussion in a Military Environment

Our primary objective is to show that early, personalized aerobic exercise treatment safely improves concussion recovery, speeds RTD, and reduces persistent symptoms in CSM. Our secondary objectives include demonstrating the clinical utility of our March-in-place test and determining fundamental mechanisms for the effect of exercise rehabilitation on concussion recovery.

Aim 1: Determine whether early sub-threshold aerobic exercise (i.e., light limited duty added to the current Department of Defense Progressive Return to Activity \[DoD PRA\]) protocol speeds return to duty (RTD), improves clinical recovery, and protects against risk of persistent post-concussive symptoms(PPCS).

Hyp 1.1: Aerobic exercise+DoD PRA early after injury speeds RTD and improves clinical recovery in CSM compared to the DoD PRA protocol alone. Hyp 1.2: Early aerobic exercise+DoD PRA protects against risk of PPCS in concussed service members (CSM) at 1 and at 3 months post-injury versus the DoD PRA protocol alone.

Aim 2: Determine whether a march-in-place test informs clinical decision-making and contributes to RTD decisions.

Hyp 2.1: The degree of early exercise intolerance on the Buffalo Concussion March Test will correlate with the development of PPCS and inform clinician decision making on RTD.

Aim 3: Determine how aerobic exercise improves concussion recovery. Hyp 3.1: Aerobic exercise improves abnormal autonomic nervous system regulation in CSM.

Hyp 3.2: Aerobic exercise reverses changes in salivary brain-derived neurotrophic factor (BDNF), BDNF-related micro RNAs, and inflammatory-related miRNAs seen in CSM.

Hyp 3.3: Aerobic exercise improves mental health (i.e., anxiety/depressive symptoms, sleep, resilience, self-efficacy, morale) in CSM.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-40 years,
* Within 9 days of injury
* Diagnosed with concussion by an experienced clinician using standard international criteria

Exclusion Criteria:

* Moderate or severe TBI as indicated by a GCS score \<13, lesion on CT/MRI, and/or focal neurologic sign consistent with intracerebral lesion
* Injury involving loss of consciousness for \>30 minutes or post-traumatic amnesia \>24 hours
* Inability to exercise because of lower-extremity orthopedic injury, clinically significant vestibular or visual dysfunction, or increased cardiac risk
* Pre-existing conditions that prevent participation in active testing and/or rehabilitation
* History of more than 3 diagnosed concussions
* Currently on medications that affect autonomic function, such as ADHD medication or mood stabilizers
* Active substance abuse/dependence
* Unwillingness to perform intervention
* Limited English proficiency.
Exploratory Study to Evaluate the Use of the RxSight Light Adjustable Lens (LAL) and the Light Delivery Device (LDD) to Improve Visual Outcomes

The objective of this study is to evaluate, for the visual correction of aphakia, whether the RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to improve visual outcomes after performing adjustments of the LAL with the LDD. This is an exploratory study. No primary effectiveness endpoints will be identified.


Eligibility Criteria:
Inclusion Criteria:

* Must sign a written Informed Consent form and be willing to undergo cataract surgery for unilateral or bilateral implantation of the RxLAL.
* Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
* Study eye must have cataract causing reduction in best corrected distance visual acuity (BCDVA) to a level of 20/32 or worse with or without a glare source.
* Willing and able to comply with the requirements for study specific procedures and visits.

Exclusion Criteria:

* Study eye with pseudoexfoliation.
* Study eye with diabetes with any evidence of retinopathy.
* Study eye with evidence of glaucomatous optic neuropathy.
* Study eye with history of uveitis.
* Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens (ICL), Corneal Inlay, or with previous pterygium excision unless the pterygium did not extend more than 2mm onto the cornea from the limbus.
* Subjects taking systemic medication that may increase sensitivity to UV light.
* Subjects taking a systemic medication that is considered toxic to the retina such as tamoxifen.
* Study eye with history of ocular herpes simplex virus.
* Study eye with history of a congenital color vision defect
Improvement in Acoustic Voice Characteristics in Functional Dysphonia After Therapy

In a retrospective analysis of already existing clinical assessment data from patients with functional voice disorders the following aspects will be sampled, encoded and analysed: Outcomes pre and post treatment of

1. subjective voice symptoms measured by Voice Handicap Index (VHI-9i),
2. perceptual voice symptoms according to Grading-Roughness-Breathiness-Asthenia-Strain Scale (GRBAS Scale),
3. instrumental acoustic analysis parameters Jitter (%), speaking voice profile: mean and range of speaking pitch and intensity, max. intensity and mean pitch of calling voice, singing voice: min./max. and range of pitch and intensity, maximum phonation time, Dysphonia Severity Index (DSI).


Eligibility Criteria:
Inclusion Criteria:

* informed consent; patients 20 to 70 years with functional voice disorder; -diagnostics and voice therapy at University Hospital Zurich;
* full pre- and post treatment voice assessment (videostroboscopy, subjective self- assessment, instrumental acoustic and perceptual analysis).

Exclusion Criteria:

* known neurologic and psychiatric disease,
* hearing disorder,
* surgery of the head and neck area or intubation (for any reason) in last 18 months.
Study of the Effect of Serelaxin on High-sensitivity Cardiac Troponin I (Hs-cTnI) Release in Patients With Chronic Heart Failure

This was a multicenter, randomized, double-blind, crossover, placebo-controlled, Phase II clinical study that evaluated the effect of serelaxin versus placebo (both in addition to SoC) on the release of hs-cTnI, in patients with CHF after an exercise testing session.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female ≥ 18 years of age, with body weight ≤ 160 Kg
* Diagnosis of stable CHF:

  * New York Heart Association (NYHA) functional Class II/III.
  * Receiving guideline-recommended treatment for CHF.
* Left ventricular ejection fraction \< 45%, obtained within the last 3 months prior to screening.
* NT-proBNP \> 300 ng/L in sinus rhythm or \> 900 ng/L if not in sinus rhythm (determined locally).
* Ability to exercise for at least 10 to 12 minutes based on investigator's judgment.
* Systolic BP ≥ 125 mmHg at randomization
* Renal function defined as an eGFR of ≥ 25 mL/min/1.73 m\^2 at screening (sMDRD formula).

Key Exclusion Criteria:

* Dyspnea primarily due to non-cardiac causes.
* Increased risk of developing hypotension during vasodilator therapy according to investigators judgement.
* Any contraindication for exercise testing and spirometry.
* Stopping of the spiroergometry at screening according to the stopping rules, unless the patient has reached maximum exercise capacity defined as carbon dioxide production/oxygen consumption (VCO2/VO2) \> 1.05.
* Change in guideline-recommended CHF treatment within 1 month prior to screening.
A Single-And Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of WD-890 Tablets in Healthy Chinese Subjects

This is a phase I, randomised, double-blind, placebo-controlled, 3-part study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of WD-890 Tablets in Healthy Chinese Subjects


Eligibility Criteria:
Inclusion Criteria：

* Signed Informed Consent.
* 18 Years to 50 Years (Adult).
* Body mass index (BMI) of 19 to 26 kg/m2, inclusive, and total body weight ：male \>=50 kg; female \>= 45.0 kg.

Exclusion Criteria：

* Has any surgery performed within 6 months prior to screening, or during the study period.
* Inability to swallow solid tablets.
* Inability to be venipunctured and tolerate venous access.
Trial to Evaluate the Efficacy of Simvastatin for Smoking Cessation

Tobacco smoking is the number one preventable cause of disease worldwide. Unfortunately, there are few smoking cessation agents and their effectiveness has been shown to be relatively limited and is associated with potential unwanted effects. Therefore, the discovery of new medications that can facilitate abstinence and reduce relapse to cigarette use represents a pressing necessity. In the attempt to find molecules that could reduce drug-seeking behavior, we discovered that simvastatin reduces cocaine and nicotine, but not food, seeking behavior in rats. This discovery of a new therapeutic application for an already marketed class of compounds may greatly facilitate the translation from preclinical to clinical setting. In this project, we aim at investigating whether simvastatin is an effective smoking cessation agent in humans.

The study design is a multicenter, randomized, double blind 2 parallel groups, clinical trial with an intention-to-treat analysis. Smokers will randomly be assigned to receive simvastatin or placebo for 3 months. 200 smokers (100 receiving simvastatin and 100 receiving placebo) will be recruited through already established networks of general practitioners. The primary outcome of the efficacy of simvastatin will be the rate of smoking abstinence during the last month of the 3-month treatment period, defined as reported continuous abstinence from smoking and confirmed by expired air carbon monoxide and urinary cotinine concentration. The last assessment will be done 6 months after the predefined quit date.

The results of this proof-of-concept study may open new perspectives in the treatment of tobacco use and dependance.


Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 and \<=70 years,
* Smoking more than 10 cigarettes per day for at least 1 year,
* Motivated to quit smoking,
* Without legal tutors or subordination,
* Affiliated to a health insurance system as required by the French law on biomedical research,
* Written informed consent for participation in the study.

Exclusion Criteria:

* Age \< 18 or \> 70 years,
* Presenting a contraindication to simvastatin use,
* With depression and/or psychosis and/or cognitive disorder and/or mental retardation or chronic use of medications for these disorders,
* Substance use disorder other than smoking,
* More than 3 months of abstinence from cigarette smoking in the previous year,
* Use of nicotine replacement therapy, bupropion, varenicline on last 3 months,
* Use of clonidine or nortriptyline on last 3 months,
* Undergoing on last 3 months' cognitive-behavioral therapy for smoking cessation,
* Premenopausal women without contraception.
Combination Therapy of Bosentan and Aerosolized Iloprost in Idiopathic Pulmonary Arterial Hypertension (IPAH)

The purpose of this study is to test whether the addition of inhaled iloprost is safe and effective in patients with idiopathic pulmonary arterial hypertension who are already being treated with the endothelin receptor antagonist bosentan.


Eligibility Criteria:
Inclusion Criteria:

* IPAH
* \> 3 months treatment with bosentan
* 6 minute walk distance 150 - 425 m

Exclusion Criteria:

* other forms of pulmonary hypertension
* severe comorbidities
* cotreatment with sildenafil or investigational drugs
L. Plantarum 299v and Gut Microbiome, Diarrhoea, and Clostridioides Difficile Infection in Colorectal Cancer Patients

Colorectal cancer in periooperative period patients (n=60) will be enrolled to this study. Participants will be divided into 4 groups as follows:

* group 1 (n=15) will receive 2 capsules (per day) of L. plantarum 299v L. plantarum 299v (Sanprobi IBS®) for 4 weeks
* group 2 (n=15) will receive L. plantarum 299v (2 capsules per day) and inulin (4 g) for 4 weeks
* group 3 (n=15) will receive placebo (2 capsules per day) and inulin (4 g) for 4 weeks
* group 4 (n=15) will receive placebo (2 capsules per day) for 4 weeks


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 oraz ≤65
* patients with colorectal cancer prior to surgical treatment
* qualification to surgery
* the treatment with chemotherapy and radiotherapy in preoperative period
* an appropriate swallowing
* patients agreement to take part in this study

Exclusion Criteria:

* the presence of other cancers than colorectal cancer
* inflammatory bowel diseases
* dysphagia
* intake of antibiotics, proton pump inhibitors, probiotics, and synbiotics 3 months befor taking part in this study
OCS Liver PROTECT Continued Access Protocol (CAP) Continuation Post-Approval Study

Post-approval observational study of subjects that were enrolled and transplanted in the OCS Liver PROTECT CAP.


Eligibility Criteria:
Inclusion Criteria:

* Subjects transplanted in the OCS Liver PROTECT CAP
Rhomboid Intercostal Block Versus Serratus Anterior Plane Block

evaluate and compare the impact of ultrasound guided rhomboid intercostal block versus serratus anterior plane block for analgesia after thoracodorsal artery perforator flap following partial mastectomy

* To assess and compare quality of post- operative analgesia in each group.
* Time of performance of block in both groups.
* To assess and compare post-operative hemodynamics as well as anticipated adverse effects including nausea, vomiting, itching, hemorrhage, bradycardia, hypotension.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged between 21 to 60 years
* Undergoing pedicled thoracodorsal artery perforator flap following breast conserving surgery -General anesthesia
* Informed consents
* ASA I \& II
* Body mass index 25-30 kg/m2.

Exclusion Criteria:

* patients on anti-platelet, anticoagulant or B blocker drugs
* Patients with acute decompensated heart failure, hypertension, heart block, coronary disease, Asthma, bleeding disorders, compromised renal or hepatic function
* history of allergy to local anesthesia or opioid analgesia,
* pregnancy.
Risk Factors for Early Acute Lung Injury After Liver Transplantation in Children

The goal of this observational study is to identify the risk factors for early acute lung injury (ALI) after liver transplantation in children .The main questions it aims to answer are what the risk factors are for early ALI in children and to evaluate the predictive value for the development of ALI.Participants will be divided into non-ALI group and ALI group according to whether they had ALI in a week after liver transplantation.Researchers will compare the difference between the two groups and use multivariate logistic regression analysis to screen the risk factors of ALI, and receiver operating characteristic(ROC) curve was used to evaluate the predictive efficacy of risk factors.

The goal of this observational study is to identify the risk factors for early acute lung injury (ALI) after liver transplantation in children and evaluate the predictive value for the development of ALI.Perioperative data of patients were obtained through electronic case information management system, anesthesia surgery clinical information system and clinical research database. Basic clinical data of children were recorded, including age, gender, alanine aminotransferase (ALT), aspartate aminotransferase (AST), International Normalized ratio (INR), childhood end-stage liver disease score (PELD) and other indicators.The expression levels of serum microRNA-122, microRNA-21, S100A9,S100A8 ,follistim like protein 1(FSTL1), tumor necrosis factor-α (TNF-α) and interleukin-1β(IL-1β) were recorded immediately after induction of anesthesia (T1), 10 min at anhepatic stage (T2), 30 min at new hepatic stage (T3) and immediately after abdominal closure (T4). Intraoperative fluid intake and outflow, ALT, AST, and serum bilirubin peaks in the first week after surgery were recorded.Murray score was used to determine whether ALI occurred one week after surgery, and the children were divided into non-ALI group and ALI group. Multivariate logistic regression analysis was used to screen the risk factors of ALI, and ROC curve was used to evaluate the predictive efficacy of risk factors.

Eligibility Criteria:
Inclusion Criteria:

* patient was diagnosed with biliary atresia
* American society of anesthesiologists physical status Ⅱ-Ⅲ

Exclusion Criteria:

* Secondary liver transplantation or other important organ injury before surgery
* Present with congenital airway or respiratory malformation
* Acute respiratory infection or respiratory insufficiency was present within 1 month before surgery
* Incomplete data
The Turkish Validity and Reliability of "Toe Walking Scale" in Children With Idiopathic Toe Walking

In clinics, many scales have been developed to examine daily living activities and function in children with idiopatic toe walking. "The Idiopatic Toe Walking (ITW)" was developed in 2010 by Cylie M.Williams, contains 21 items which measure medical, birth \& developmental history and assessment. The aim of the investigator's study was to investigate translating the ITW scale and using it in clinics reliably and valiably with a Turkish version of ITW in children with idiopatic toe walking.

Demographic information was recorded which are included gender, age, using orthosis, botox/surgical history, use and duration of walkers/child-runner (WCR). The scale was translated into Turkish with the following translation steps. Thirty four children with idiopatic toe walking were included in the study. Internal structure consistency and test-retest reliability were measured for reliability analyses. For each item on the scale, Cronbach's alpha coefficient and item-total score correlations were calculated. The scale was administered for test-retest reliability at baseline and one week later by one rater. Test-retest reliability was assessed by Pearson's correlation test with observational gait analysis and 'co-validity' was investigated, statistically.

Eligibility Criteria:
Inclusion Criteria:

* older than 3 years
* without neurologic, orthopethic or psychiatric illnesses
* still walking on toe

Exclusion Criteria:

* absence of any known medical conditions
* no voluntary to participate
* older than 18 years or younger than 3 years
Cognitive Behavioral Therapy Combined With Antidepressants to Reduce HIV Risk and Drug Relapse Among Depressed Intravenous Drug Users

This study will evaluate the effectiveness of combining cognitive behavioral therapy (CBT) and antidepressants in reducing HIV risk behavior and drug relapse rates in depressed intravenous drug users.

Depression is common among injection drug users (IDUs); it is estimated that up to 50% of IDUs meet the diagnostic criteria for major depressive disorder, a severe form of depression. The combination of drug abuse and depression increases the likelihood of engaging in HIV high-risk behaviors such as unprotected sex and the use of unhygienic needles to inject drugs. Research has shown that IDUs who receive treatment for depression have lower rates of drug relapse and are less likely to engage in high-risk sexual behavior compared to IDUs who have not received treatment for depression. Combination treatment, which includes cognitive behavioral therapy (CBT) and antidepressant medication, has been shown to be the most effective treatment for depression. This study will evaluate the effectiveness of combination treatment in reducing HIV risk behaviors and drug relapse rates in cocaine or opiate addicted IDUs with a diagnosis of depression.

In this 9-month study, participants will be randomly assigned to either a combination treatment group or an assessment only group that will receive no treatment. Participants assigned to combination treatment will receive the antidepressant Celexa, and will attend 8 CBT sessions and 7 psychopharmacology sessions. Each CBT session will last about 60 minutes and each psychopharmacology session will last about 15 minutes. If a participant does not respond well to Celexa, Wellbutrin or Effexor may be taken instead. Participants in both groups will attend 4 study visits during which they will complete standardized psychological questionnaires and interviews to assess depression levels, drug use, and high-risk sexual behaviors. Blood will be drawn at baseline and Month 9 for HIV testing.

Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for major depression, dysthymia, substance-induced major depression, or major depression plus dysthymia
* Score of greater than 14 on the Hamilton Depression Rating Scale
* Involved in HIV risk behaviors
* Current opiate or cocaine use
* Basic proficiency in English

Exclusion Criteria:

* Current suicidal risk or ideation
* Current psychotic symptoms
* Simultaneous medical disorder that might make psychopharmacological treatment medically inadvisable
* History of bipolar disorder, schizophrenia, schizo-affective disorder, schizophreniform disorder, or paranoid disorder
* Currently taking other medications for depression
Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers

The study was conducted to investigate whether 2 mg cyproterone acetate (CPA) and 0.035 mg ethinyl estradiol (EE) film-coated tablet (Elzsa®) manufactured by PT. Sydna Farma was bioequivalent to its reference product, Diane®-35 sugar-coated tablet manufactured by Bayer Weimar GmbH, Germany, imported by PT. Bayer Indonesia, Depok, Indonesia.

Twenty four healty female subjects were given a single dose of Elzsa® FCT or or Diane®-35 with 240 mL of water. Then the blood samples for CPA and EE were drawn and analyzed using LCMS/MS. All subjects sample plasma were analyzed for pharmacokinetic evaluation

Eligibility Criteria:
Inclusion criteria

The inclusion criteria are healthy female subjects who/with:

* have read the subject information and signed informed consent documents
* age 18 - 55 years
* body mass index between 18-25 kg/m2
* have a normal electrocardiogram
* blood pressure within normal range (90-120 mmHg for systolic blood pressure and 60-80 mmHg for diastolic blood pressure)
* heart rate within normal range (60-100 bpm)
* with absence of significant disease or clinically significant abnormal laboratory values on laboratory evaluation, medical history or physical examination during screening
* pass hormone screening related to cyproterone acetate and ethinyl estradiol

Exclusion criteria

Any of the following criteria will exclude the subject from the study:

* those who are pregnant and/or nursing woman.
* those with history of hypersensitivity to cyproterone acetate and ethinyl estradiol or other oral contraception or other ingredients in the drugs or a history of serious allergic reaction to any drug, significant allergic disease, allergic reaction, or active allergic.
* those with a history or presence medical condition which might significantly influence the pharmacokinetic of the study drug, e.g. chronic gastrointestinal disease, diarrhea, gastric surgery, renal insufficiency, hepatic dysfunction or cardiovascular disease.
* those with a history or presence of any coagulation disorder or clinically significant hematology abnormalities, thrombophlebitis, and thromboembolic disorder.
* those who are using any medication (prescription or non-prescription drug, food supplement, herbal medicine, oral contraception, anti-platelet drug), particularly the medication known to affect the pharmacokinetic of the study drug, within one week prior to the drug administration day.
* those who have participated in any clinical study within 3 months prior to the study (\< 90 days).
* those who have donated or lost 300 ml (or more) of blood within 3 months prior to the study.
* those who smoke.
* those who are positive to HIV, HBsAg, and HCV tests (to be kept confidential).
* those with a history of drug or alcohol abuse within 12 months prior to screening for this study.
* those who are unlikely to comply with the protocol, e.g uncooperative attitude, inability to return for follow up visits, poor venous access.