cyrilzakka/clinical-trials huggingface dataset:
Leucine Enriched Essential Amino Acid Mixture to Reverse Muscle Loss in Cirrhosis

Loss of skeletal muscle mass or sarcopenia is the most common and potentially reversible complication in cirrhosis that increases morbidity and mortality before, during and after liver transplantation. No proven treatments exist for the prevention or reversal of sarcopenia in cirrhosis, primarily because the mechanisms responsible for this are unknown. Based on compelling preliminary studies and those of the co investigator, investigators hypothesize that the mechanism of reduced skeletal muscle mass in cirrhosis is due to a myostatin mediated impaired mTOR (mechanistic target of rapamycin) signaling resulting in reduced protein synthesis and increased autophagy. Investigators further postulate that leucine, a direct stimulant of mTOR, will reverse the impaired mTOR phosphorylation in the skeletal muscle of cirrhotics. The consequent increase in protein synthesis reduced autophagy will result in an increase in skeletal muscle mass. Investigators will test these hypotheses by quantifying the response to acute and long term (3 month) administration of leucine enriched essential amino acid (EAA/LEU) compared with an isonitrogenous isocaloric non-essential balanced amino acid mixture (does not stimulate protein synthesis) in cirrhotic patients. Fractional protein synthesis rate (FSR) in skeletal muscle, responses of the molecular regulatory pathways of skeletal muscle protein synthesis, and autophagy flux will be quantified in the acute and long term protocols. Tracer studies using L-\[D5\]-phenylalanine (Phe) as a primed constant infusion (prime 2µmol.kg-1.hr-1; constant 0.05 µmol.kg-1.hr-1) with and L \[ring-D2\] tyrosine, forearm plethysmography, and sequential skeletal muscle biopsies (total of 3 per study subject) will be used to quantify these outcomes. Anthropometric, clinical and body composition measures will be additional outcome measures for the long term intervention. Expression of regulatory signaling proteins, myostatin, IGF-1 (insulin like growth factor) , phospho-Akt, phospho-AMPK (activated protein kinase), phospho-mTOR and phospho-p70s6k will be quantified by Western immunoblots. Autophagy flux will be measured by quantifying expression of the autophagosome proteins.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients:
* Cirrhosis diagnosed by liver biopsy and/or clinical, biochemical and imaging evidence of cirrhosis.
* Abstinence from alcohol and/or other recreational drugs for at least 6 months
* Child's Pugh score 5-9 (inclusive).

Exclusion

* Cirrhotic patients:
* Child's score \>9
* Pedal edema above the ankle
* Presence of concurrent illnesses (renal, cardiac, pulmonary, cerebrovascular, malignancy) or medication (anabolic steroids, corticosteroids) intake that affect skeletal muscle mass.
* Diabetes mellitus
* Active gastrointestinal bleeding
* Sepsis, encephalopathy
* Renal failure
* Hepatocellular carcinoma outside of Milan criteria
* Unwilling to sign informed consent or follow research procedures
* Does not meet inclusion criteria
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation

This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.

The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially to treat longstanding persistent Atrial Fibrillation (AF) patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years; \< 80 years
* Left atrium less than or equal to 6.5 cm (TTE)
* History of AF for less than or equal to 10 years
* Provided written informed consent
* Symptomatic longstanding persistent Atrial Fibrillation (AF).

Exclusion Criteria:

* Patients requiring concomitant surgery
* Left ventricular ejection fraction \< 30%
* Pregnant or planning to become pregnant during study
* Co-morbid medical conditions that limit one year life expectancy
* Measured left ventricular wall thickness \> 1.5 cm
* History of coagulopathy
* Previous cardiac surgery
* History of pericarditis
* Previous cerebrovascular accident (CVA), excluding fully resolved TIA
* Patients who have active infection or sepsis
* Patients who have uncorrected reversible cause(s) of AF
* Patients who are contraindicated for anticoagulants
* Patients who are being treated for arrhythmias other than AF
* Patients who have had any previous AF or left atrial catheter ablation
* Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment
* Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).
Expanded Access for the Treatment of Advanced Cholangiocarcinoma With ABC294640 (Yeliva ®)

This is an expanded access program (EAP) for eligible participants who do not qualify for participation in, or who are otherwise unable to access, the ongoing clinical trial ABC-108. This program is designed to provide access to ABC294640 (Yeliva ®) for treatment of cholangiocarcinoma (CCA) prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. An oncologist must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cholangiocarcinoma
2. Ineligible to participate in the ABC294640 clinical trial for the treatment of cholangiocarcinoma or geographically inaccessible to the trial.
3. Judged by the treating oncologist to be medically suitable for treatment with ABC294640
4. Willing and able to provide written, signed informed consent
5. Approval by RedHill of the treating oncologist's clinical trial experience for the purpose of making ABC294640 available
6. Regulatory approval by the appropriate jurisdiction

Exclusion Criteria:

1. Any medical condition that may cause treatment with ABC294640 to be potentially harmful as judged by RedHill
A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

The purpose of this study was to evaluate the continued use of ipilimumab in patients who had reinduction at the time of disease progression or to continue maintenance treatment. In addition, this study will continue to follow patients who have taken ipilimumab, but who are not eligible for maintenance or reinduction therapy.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Key Inclusion Criteria

* Diagnosis of advanced melanoma
* Prior treatment in a prespecified prior/parent ipilimumab study
* Men and women 18 years of age and older

First Reinduction:

* No unacceptable toxicity (except select reversible immune-related adverse events) requiring ipilimumab discontinuation
* Had experienced documented progressive disease after expanded clinical benefit

Extended Maintenance

* Received ipilimumab at any dose in a parent study
* Achieved expanded clinical benefit at the time of entry to current study

Follow-up:

* Received ipilimumab at any dose in a closing parent study
* Deemed ineligible for reinduction or extended maintenance treatment or refused treatment as reinduction or extended maintenance at the time of screening in the current study, but consented to follow-up

Key Exclusion Criteria

* Prior treatment with a CD137 agonist or a cytotoxic T-lymphocyte antigen 4 inhibitor or agonist, other than ipilimumab
* Primary ocular or mucosal melanoma
Focal Myometrial Contractions: Impact on Cervical Assessment and Association With Voiding

Focal myometrial (uterine) contractions occur in a substantial number of vaginal ultrasound examinations and can impede accurate cervical length measurement and placental location determination. The timing of bladder voiding is associated with the prevalence of focal myometrial contractions on vaginal ultrasound cervical assessment. We propose a blinded randomized-controlled trial of bladder voiding immediately before vaginal ultrasound for cervical assessment compared with no bladder voiding immediately before vaginal ultrasound in order to determine the prevalence of focal myometrial contractions during vaginal ultrasound cervical assessment and test whether timing of bladder voiding is associated with their incidence.

This blinded randomized-controlled trial will be performed through the Division of Maternal Fetal Medicine at Beth Israel Deaconess Medical Center. We will offer enrollment to any pregnant woman at gestational weeks 14+0/7 through 31+6/7 presenting for obstetric ultrasound where cervical assessment and/or placental location determination is indicated. Patient positioning and image acquisition will follow a standard protocol and will be performed by the co-investigators. Outcome ascertainment will be performed by two co-investigators blinded to participant allocation upon completion of data collection. Demographic and obstetrical outcome data will be collected via review of the medical record. Analysis of primary and secondary outcomes will yield incidence data, and comparisons will be made between groups.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age of 14+0/7 through 31+6/7 weeks
* Presenting for obstetric ultrasound in the MFMU for cervical assessment and/or placental location determination
* Verbal consent
* Ability to refrain from urination for at least 15 minutes
* Age 18 years or greater

Exclusion Criteria:

* N/A
Contingency Management for Alcohol Use Disorder

Randomized pilot study of a device (smartphone app) that poses non-significant risk to participants and is exempt from Investigational Device Exemption regulations \[21 Code of Federal Regulations 812.2(c)

To test the feasibility/acceptability and efficacy of a minimum viable product (MVP) of a smartphone app for patients with alcohol use disorder who are in active treatment and recovery to perform self-tracking of their recovery behavior (e.g., abstinence) and focus on their motivation to maintain their desired health behaviors (i.e., abstinence).

Eligibility Criteria:
Inclusion Criteria:

Participants in the pilot study will be 60 new intakes to Gosnold's outpatient Substance Use Disorder (SUD) program who:

* are \>18 years old;
* meet DSM-5 criteria for current (past year) alcohol use disorder, at least moderate severity;
* identify alcohol as the primary drug problem;
* Currently use alcohol (past 7 days) or have been in treatment 14 days or less and used alcohol within 7 days of treatment entry;
* have and use an Android or iOS smartphone with acceptable
* capability;
* are willing to participate in home testing and use of the smartphone,
* speak and read the English language adequately to understand smartphone commands and responses and
* are willing to be randomly assigned to receive treatment with or without the smartphone app as an added feature.

Exclusion Criteria:

• Participants must not currently be suicidal or actively psychotic, by clinician judgement.
3D Radiographic Evaluation of a Novel Implant Site Development Technique

The present retrospective study aims at assessing the clinical effects of a novel implant site development (Extraction site development - XSD) technique after tooth extraction compared with extraction alone in patients requiring dental implant placement following healing of extraction sockets.

In advanced (Extraction Defect Sounding Class 3-4) alveolar defects, a minimally invasive tunnelised socket preservation technique utilising long term resorbable membranes and connective tissue grafting was used for extraction site development (XSD). The novel technique was evaluated in a retrospective comparative case series study including a total of 54 extraction sites. In the test group, out of 33 single rooted teeth, 29 in the maxilla and 4 in the mandible were removed, extractions sites were treated by the XSD method. Out of 33 teeth, 27 were incisors, 2 canines and 4 premolars. In the control group, out of 21 single rooted teeth, 11 in the maxilla and 10 in the mandible were extracted and left for spontaneous healing. Out of 21 teeth, 13 were incisors, 2 canines and 6 premolars. CBCT scans were taken prior to tooth extraction and 6-9 months later in both groups. Radiographic evaluation was carried out using the I-CAT Vision (Imaging Sciences International, LLC; Hatfield, USA) and ImageJ (National Institutes of Health) softwares. Following manual alignment of CBCTs vertical and horizontal linear measurements as well as planimetric measurements of cross-section areas were performed in pre- and postoperative data sets at the extraction sites.

Eligibility Criteria:
Inclusion Criteria:

Presence of at least 1 single rooted tooth scheduled for extraction with EDS Class 3-4 type buccal bony dehiscence

Exclusion Criteria:

Exclusion criteria int he test group included uncontrolled inflammation at the surgical site, full mouth plaque or bleeding scores more than 20%, diabetes, pregnancy, known metabolic bone diseases, smoking more than 10 cigarettes a day, history of any relevant systemic diseases, radiotherapy chronic use of bisphosphonates or systemic steroids.
Stivarga Real Life Evidence in Hungary

The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study should provide information about clinical characteristics of Hungarian regorafenib patients as well as information about safety and efficacy of regorafenib in Hungarian patients with metastatic colorectal cancer. This much needed data is required by the National Health Insurance Fund in order to accept regorafenib into the regular reimbursement system. This study is proposed to be based on patient data from the Hungarian National Health Insurance Fund's Database. Data to be analyzed includes patient demography and baseline tumor characteristics, overall survival, time to treatment failure, duration of treatment, average dose and dose modifications, and adverse events. Further, treatment costs will be estimated.


Eligibility Criteria:
Inclusion Criteria:

* Using the National Health Insurance Database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle (=28 days).

Exclusion Criteria:

* Not applicable
Comparison of the Frequency of Subclinic Synovitis in the Distal Interphalangeal Joints of the Hand in Psoriasis Patients

In this cross-sectional study, it was planned to compare the frequency of subclinical synovitis in the distal interphalangeal joints of the hands in psoriasis patients. 28 patients followed up by the Dermatology Department with a diagnosis of psoriasis and referred to us and 28 healthy volunteers were included in the study. Participants' age, gender, body mass index (BMI), year of psoriasis diagnosis, treatments they received, and comorbid diseases were recorded as demographic information. Psoriasis Area and Severity Index (PASI) and Nail Psoriasis Severity Index (NAPSI) were calculated by a dermatologist.

Tenderness in the distal interphalangeal joints of both hands was evaluated by palpation.

Subsequently, the presence of ultrasonographic synovitis findings of the participants was examined by a physician who was experienced in musculoskeletal ultrasonography and was blind to clinical evaluations. Scoring was done with the EULAR GS / PD joint scoring system and EULAR-OMERACT composite scoring system. The scores of the most affected joint were used in statistical analysis. Comparisons were made between psoriasis and control groups in terms of scores. Relationships between variables in the psoriasis group were examined.


Eligibility Criteria:
Inclusion Criteria:

For patient group

1. Being over the age of 18
2. Being followed up by the Dermatology Department with a diagnosis of psoriasis and receiving topical or systemic treatment for this
3. Absence of clinically detected signs of arthritis
4. Absence of serious trauma, surgical intervention or injection in the joint areas to be evaluated.
5. Absence of any known inflammatory rheumatic disease For control group

1.\> 18 years old 2. Absence of clinically detected signs of arthritis 3.Lack of clinical signs suggestive of psoriasis

Exclusion Criteria:

For patient group

1. To be \<18 years old
2. Clinically detected evidence of arthritis
3. History of serious trauma, surgical intervention or injection in the joint areas to be evaluated
4. Having a known inflammatory rheumatic disease For control group

1. To be \<18 years old 2. Having clinical signs suggestive of psoriasis 3. Having clinically detectable signs of arthritis 4. History of known inflammatory disease, severe trauma in the joint areas to be evaluated, surgical intervention, injection

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Media Diversion in Improving Quality of Life in Patients With Recurrent Gynecologic Cancers Receiving Chemotherapy

This randomized clinical trial studies media diversion in improving quality of life in patients with recurrent gynecologic cancers receiving chemotherapy. Media diversion may improve mood and quality of life in patients having cancer treatment.

PRIMARY OBJECTIVES:

I. To analyze the impact of a media-based intervention on patient mood during the receipt of chemotherapy for recurrent gynecologic cancers.

OUTLINE: are randomized to 1 of 2 arms.

ARM I: Participants are provided headphones and a tablet and choose among a selection of humorous movies. Upon the third course of chemotherapy, participants are provided a selection of non-humorous movies.

ARM II: Participants are provided headphones and a tablet and choose among a selection of non-humorous movies. Upon the third course of chemotherapy, participants are provided a selection of humorous movies.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with pathologically-proven gynecologic malignancies
* Subjects who have previously completed primary treatment for a gynecologic malignancy
* Patients receiving chemotherapy for a recurrent gynecologic cancer at the University of Wisconsin-Madison Carbone Cancer Center (UWCCC)
* Patients must be English speaking
* Patients must have the ability to use audio media and read and understand written English

Exclusion Criteria:

* Patients unable to use audio or video media due to auditory or ocular dysfunction
* Patients unable to read written English
* Patients who are prisoners or incarcerated
Does Sport Specific Brain Endurance Training Enhance Physical and Cognitive Performance in Elite Orienteering Athletes?

The purpose of the study is to measure the effects of a 6 week sport specific BET intervention on physical and cognitive performance parameters in elite orienteering athletes.

The purpose of the study is to measure the effects of a 6 week sport specific BET intervention on physical and cognitive performance parameters in elite orienteering athletes.

The study is constructed as a cross-over design, where participants function as their own control condition. The control condition (the first period) and the intervention (the latter period) consists of a 6 week training period, both leading up to a prioritized international competition. In the control condition participants will train normally leading up to the European Championships. During the intervention period participants will implement 3 sessions per week of a specially designed brain endurance program, leading up to the World Championships. To investigate the effect on all endpoints, physical and cognitive tests are conducted before and after the training periods.

Eligibility Criteria:
Inclusion Criteria:

* Danish National Team Elite Orienteering Runners

Exclusion Criteria:

* Consent withdrawal
* Injury
Integrated Neuromuscular Inhibition Versus Instrument Assisted Soft Tissue Mobilization in Chronic Back Pain

this study will be conducted to identify the difference between the effect of integrated neuromuscular inhibition technique and instrument assisted soft tissue mobilization on back pain, pain threshold, back rang of motion ,back proprioception and back disability in chronic non specific low back pain


Eligibility Criteria:
Inclusion Criteria:

* 1. The patient's age ranged from 18 to 30 years.(Geogre et al, 2021) 2. Patients with low back pain for more than 3 months (pain felt between T12 and the gluteal fold).

  3. Patient with chronic low back pain 4. Normal body mass index from 18 -25kg/m2.

Exclusion Criteria:

* The subjects will be excluded if they have any of the followings:

  1. Lumbar discogenic lesions or any inflammatory arthritis, tumors, infection involving the lumbar spine.
  2. Patients with decreased range of motion secondary to congenital anomalies, muscular contracture, or bony block.
  3. Previous lumbar or hip surgery or trauma.
  4. Any hip structural abnormality such as malformations, impingements and degeneration.
  5. Patients With cognitive impairments that would limit their participation