cyrilzakka/clinical-trials huggingface dataset:
Study of Tolerability and Efficacy of BVS857 in Severe Burn Subjects

Study of tolerability and efficacy of BVS857 in severe burn subjects over 8 weeks and 15 weeks

No formal analysis was performed as study was terminated due to low enrollment issues. (n=1 patient was enrolled)

Eligibility Criteria:
Inclusion Criteria:

* Burn injury comprising 2nd degree deep partial thickness and/or 3rd degree full thickness burns, ≥20% total body surface area with expected need for surgical intervention and not exceeding the sum of age plus burn size of 100 (Baux score)
* Dosing must occur within 8-12 days post-burn
* Subjects must weigh at least 45kgs (for group 1 with doses of 0.03mg/kg) and be under 100 kg to participate in the study

Exclusion Criteria:

* Spinal cord injury
* Hypoxic brain injury (Glasgow Coma Scale (GCS) \<8) at screening
* True conductive electric burn with suspected neurologic injury
* Uncontrolled diabetes with HbA1c \> 10% at screening, or known history of hypoglycemia,
* History of or active peripheral neuropathy or seizure disorder
* Systemic corticosteroids : \> 10mg/d of prednisone or equivalent, other investigational treatments (excluding investigational dressings), medications for weight loss including megestrol acetate, androgens or oral beta agonists
Preventing Perinatal Depression with an App-Based CBT Program

The goal of this clinical trial is to learn if CareMom, a mobile app-based cognitive behavioral therapy program works to prevent perinatal depression among Chinese mothers. The main questions the trial aims to answer are:

1. Does CareMom lower depression scores after an 8-week intervention?
2. Does CareMom lower depression scores at 6 weeks after childbirth?
3. How satisfied are participants with CareMom?
4. What unfavorable events, if any, are associated with the use of CareMom?

Researchers will compare CareMom to a matched attention control (a mobile app-based program that offers participants a similar level of interaction and daily activities) to see if CareMom works to prevent perinatal depression.

Participants will:

1. Engage in the CareMom program or a relaxation training program every day for 8 weeks
2. Complete a series of online questionnaire tests before and after the 8-week intervention.
3. Report any discomfort experienced throughout the study period.

A two-arm parallel randomised controlled trial of 290 pregnant women will be conducted at Jintang County Maternity and Child Health Hospital of Chengdu, China. Eligible women who consent to participate in the trial will be recruited at 20-24 weeks of gestation, and randomly allocated to either the intervention group (participate in a mobile app-based 8-week cognitive behavioral therapy program, named CareMom) or the control group (participate in a mobile app-based, attention-matched, 8-week relaxation training program) using a computer-generated random number. The primary outcomes are the changes in Edinburgh Postnatal Depression Scale (EPDS), Patient Health Questionnaire-9 (PHQ-9) and 7-item Generalized Anxiety Disorder (GAD-7) scores from From enrollment to the end of intervention at 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-45 years
* at 20-24 weeks of gestation
* at risk of depression but not experiencing severe depressive symptoms at recruitment, as indicated by an Edinburgh Postnatal Depression Scale (EPDS) score of between 5 and 12
* own a smartphone
* are able to independently engage with the program

Exclusion Criteria:

* have serious medical conditions or pregnancy complications that may affect their psychological condition, as determined by their medical doctor
* have a prior diagnosis of any mental disorders
* are currently or were recently (within the past six months) receiving any kinds of psychological services or treatments
* have a history of self-harm or suicide
* have any suicidal thoughts in the past 12 months
* experienced fetal deaths in the past 18 months
Non-IRA Functional Evaluation With AccuFFRangio in NSTE-ACS

This is a prospective, single-center clinical trial. AccuFFRangio (ArteryFlow Technology Co., Ltd., Hangzhou, China) is a novel method for evaluating the functional significance of coronary stenosis by computing the pressure in the vessel based on angiographic images. The purpose of this study is to investigate the diagnostic performance and prognostic ability of AccuFFRangio for non-IRA in NSTE-ACS patients.


Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* Non-ST-segment elevation acute coronary syndrome patients with at least 1 non-IRA
* Diameter stenosis of 50%-90% by visual estimate
* Reference vessel size \> 2 mm in stenotic segment by visual estimate

Exclusion Criteria:

* LVEF ≤ 40%
* eGFR \< 60 mL/min
* Allergy to contrast media, adenosine
* Prior CABG
The BabyGrow Longitudinal Study of Nutrition and Growth in Preterm Infants

This is a longitudinal, observational study on nutrition, growth and body composition in preterm infants. Aims to determine the adequacy of actual nutrient intake during the preterm period by investigating associations between macronutrient supply, growth, and body composition at 34-weeks gestation, term equivalent and 2-month corrected gestational age.

Infants between 23 and 24 weeks gestation and with a birth weight of 500 to 1500 g are recruited to a longitudinal, observational study of nutrition, growth and body composition in Cork University Maternity Hospital, Ireland.

Eligibility Criteria:
Inclusion Criteria:

* Babies with a birth weight ≤1.5kg and gestational age ≤34 weeks were considered eligible.

Exclusion Criteria:

* presence of congenital abnormalities or conditions that interfere with growth or body composition (congenital diseases, chromosomal abnormalities, chronic lung disease, cardiac or gastrointestinal diseases).
Preserved Umbilical Vein Use as Autologous Shunt Conduits in Neonatal Cardiac Surgery

This is a prospective, single center, safety and feasibility trial to evaluate the use of autologous umbilical vein as shunts or conduits in neonatal cardiac surgery. Subjects will be identified here at the Advanced Fetal Care Center (AFCC) following diagnosis of congenital heart disease (CHD) with single ventricle physiology of the fetus via fetal echocardiogram. At time of cesarean section or vaginal delivery, umbilical cord will be harvested in a sterile fashion and the umbilical vein will be dissected free and preserved until first clinically indicated Stage I palliative procedure between day 3 and 7 of life. Subjects will be followed until their Stage II palliative procedure.


Eligibility Criteria:
Inclusion Criteria:

* All fetal diagnoses of complex congenital heart disease diagnosed by fetal echocardiogram requiring cardiac repair with Blalock-Taussig Shunt or Right Ventricle to Pulmonary Artery conduit will be eligible.
* This includes all pre-natal diagnoses of any single ventricle circulation physiology (SVP).
* Subjects being delivered via cesarean section or vaginally at Brigham and Women's Hospital will be considered.

Exclusion Criteria:

* meconium at delivery
* symptomatic Group B Streptococcus (GBS) positive mothers
* mothers with chorioamnionitis
* Hepatitis B or C positive mothers
* HIV positive mothers.
* If unable to collect viable cord on the day of delivery of already enrolled subjects, the subject will be removed from the study on day of birth.
Study of the Safety, Tolerability, and PK of MRX-8 Administered Intravenously to HVs in SAD and MAD Cohorts

This Phase 1 study is designed to assess the safety and tolerability of single and multiple intravenous (IV) doses of MRX-8, to assess the pharmacokinetics of MRX-8 and its primary metabolite following single and multiple IV doses, and to measure the elimination of MRX-8 and its metabolite in urine.

This is a first-in-human, randomized, double-blind, placebo-controlled study consisting of 3 parts. Part 1 will evaluate single ascending doses (SAD) of study drug. Part 2 will evaluate multiple ascending doses (MAD) of study drug administered for 7 days. Part 3 will evaluate MAD of study drug administered for 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent
* In good general health

Exclusion Criteria:

* Prior participation in a study utilizing a polymyxin or aminoglycoside antibiotic or other nephrotoxic drug within the 12 months prior to study drug administration on Day 1
* Use of tobacco or nicotine products, in any form, within 30 days prior to study drug administration on Day 1
* Venous access considered inadequate for IV infusions, laboratory safety assessments, or PK sample collection
* Underlying hepatic, renal, metabolic, cardiovascular or immunologic disorders
Multimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient

Establishment and validation of the deep learning model of Cetuximab efficacy in simultaneous RAS wild unresectable CRLM patients

Ras wild unresectable CRLM patients with primary tumor resection followed by Cetuximab in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, almost 100 CRLM patients were classified into two groups (Clinician drived regimen vs Multi-omics model drived regimen). They will be the prospective cohort to validate our deep learning model for predicting Cetuximab efficacy.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-75 years;
2. Histologically proven colorectal adenocarcinoma;
3. Simultaneous liver-limited metastases;
4. Initially unresectable liver metastases determined by a local MDT;
5. Life expectancy of \> 6 months;
6. RAS and BRAF V600E wild-type;
7. ECOG 0-1;
8. Available CT imaging before treatment.

Exclusion Criteria:

1. Previous systemic treatment for metastatic disease;
2. Previous surgery for metastatic disease;
3. Extrahepatic metastases;
4. Unresectable primary tumor;
5. Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
6. Acute or subacute intestinal obstruction;
7. Second primary malignancy within the past 5 years;
8. Drug or alcohol abuse;
9. No legal capacity or limited legal capacity;
10. Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;
Local mEHT + TCM Versus Intraperitoneal Chemoinfusion in Treatment of Malignant Ascites: Phase II RCT

This trial studies efficacy and safety of combination of modulated electro-hyperthermia (mEHT) with Traditional Chinese Medicine (TCM) in treatment of peritoneal carcinomatosis with malignant ascites versus standard chemoinfusion (CDDP+5FU).

Conservative treatment of peritoneal carcinomatosis with malignant ascites (PCMA) is based on chemoinfusion with its inherent toxicity. There is a strong demand for a safe and non-toxic method of treatment of PCMA. The new technology of modulated electro-hyperthermia (mEHT) has proven efficacy in many advanced cancers with minimal side effects and synergy with Traditional Chinese Medicine (TCM). TCM has a long history of application at advanced cancer as a symptomatic treatment and enhancer of the general resistance of the organism. Shi Pi Decoction is supposed to be the optimum co-treatment of PCMA according to principles of TCM. Intraperitoneal chemoinfusion (IPCI) with cisplatin and fluorouracil is a widespread standard treatment of PCMA in China. This randomized II phase trial studies efficacy and safety of combination of mEHT with TCM in treatment of PCMA versus standard IPCI (CDDP+5FU).

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed PC with malignant ascites.
* Karnofsky Performance Status (KPS) score ≥60%.
* Normal function of bone marrow.
* Predicted survival time \>1 month.
* Written informed consent.

Exclusion Criteria:

* Surgery within 3 weeks or not full recovery of postoperative suture.
* Active bleeding or vascular occlusion in the mEHT treatment area.
* Emotional instability.
* Impossibility to place the patient into the mEHT machine.
* Metallic implants or replacements in the treatment area.
* Electronic implanted devices anywhere.
* Missing or damaged heat-sense nerves or other field-sensitive issues in the treatment area.
* Very low white blood cell count (\<1.5×10(9)/L), agranulocytosis (\<0.5×10(9)/L) or severe anemia.
A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients

This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and Nateglinide inhibitor in Japanese patients with type 2 diabetes mellitus.

This is a 52-week multi-center, open-label, non-comparative study in subjects with type 2 diabetes mellitus who have inadequate glycemic control on Nateglinide alone more than 4 weeks. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients receiving with Nateglinide mono-therapy for at least 4 weeks
* HbA1c value between 6.5 and 9.5%
* Body Mass Index (BMI) 20.0 - 45.0 kg/m2

Exclusion Criteria:

* Type 1 diabetes mellitus patients
* Serum creatinine \> upper limit of normal
* Proteinuria (albumin/creatinine ratio \> 300mg/g)
* Dysuria and/or urinary tract infection, genital infection
* Significant renal, hepatic or cardiovascular diseases
* Severe gastrointestinal diseases
Comparison of Effectiveness Between Active Release Technique and Hold Relax Technique in Patients With Piriformis Syndrome

This study is a randomized controlled trial and the purpose of this study is to compare the effects between active release technique and hold relax technique in patients with Piriformis syndrome.

The purpose of this study is to compare the effects between active release technique and hold relax technique in patients with piriformis syndrome pain, range of motion, and functional disability, in adults (age: 25-55 years)

1. Numeric pain rating scale
2. Goniometer
3. Oswestry Disability Questionairre Data will be collected before and after the intervention protocol for each participant.

Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post-intervention scores will be recorded.

Eligibility Criteria:
Inclusion criteria:

* Gender: Both male and female
* Individuals aged 25-55 years
* Tenderness to palpation over sciatic foramen
* Positive FAIR Test.

Exclusion criteria :

* History of hip, pelvic, or Femoral fractures.
* Malignancies.
* Avascular necrosis of Femoral head.
* Inflammatory conditions (e.g. Rheumatoid Arthritis)
Prospective Trial to Evaluate the Safety and Efficacy to Treat Esophageal Cancer Using 5-FU, Oxaliplatin, and Docetaxel

The current multicenter prospective phase II study aims to evaluate the safety and efficacy of preoperative FLOT therapy for esophageal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically diagnosed as esophageal squamous cell carcinoma (squamous, adenosquamous, basaloid)
2. Primary tumor is located mainly in the thoracic esophagus
3. cT1N1-3M0-1 (only supraclavicular LN metastasis is included as M1), cT2-3N0-3M0-1 (only supraclavicular LN metastasis is included as M1)
4. Twenty years old or older as of registration
5. Performance status (PS) 0 or 1
6. Patients have target lesions
7. No previous history of esophageal cancer except for the followings

1) pT1a-LPM (M2) or deeper following EMR/ESD 2) pT1a-MM (M3) with vascular invasion following EMR/ ESD 8. No previous history of chemotherapy/radiotherapy/endocrine therapy except for hormone therapy for prostate cancer after 5 years interval 9. Patients who meet the following criteria

1. Neutrophil \> 1,500 /mm3
2. Platelet \> 10.0x10\^4 /mm3
3. Hb ≧9.0 g/dL
4. Total bilirubin ≦ 1.5 mg/dL
5. AST ≦ 100 IU/L
6. ALT ≦ 100 IU/L
7. SpO2 ≧ 95 %
8. Creatinine clearance ≧ 50 mL/min 10. Patients who can undergo esophagectomy 11. Agree with the participation to the current study

Exclusion Criteria:

1. Patients who received any treatment for cancer within 3 years
2. Patients who have active infectious diseases
3. HBs Ag positive or HIV Ab positive
4. Pregnant or breast feeding
5. Patients with psychological disorder
6. On systemic steroid therapy
7. Require flucytocine, phenytoin, warfarin
8. Allergic to iodine
9. Allergic to DTX, LOHP, polisorbate 80
10. Uncontrollable diabetes
11. Severe COPD or lung fibrosis
12. Severe hypertension
13. Unstable angina
14. Patients whom investigators evaluate as ineligible
Turkish Version of Digital Eye Strain Questionnaire (DESQ)

The aims of this study were to perform cultural adaptation of the DESQ and provide information regarding the factor structure, reliability and validity of the instrument in Turkish speaking adults.


Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65 years
* People who spend two or more continuous hours a day on their digital devices (computer, tablet, smartphone) or use more than one device

Exclusion Criteria:

* History of ophthalmic surgery or active ocular disease
* Participants who did not understand the instructions or did not sign a consent form were excluded
Efficacy of Adding Lower Extremity Weights on Balance in Children With Ataxic Cerebral Palsy

Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is


Eligibility Criteria:
Inclusion Criteria:

* ataxic cerebral palsy aged 7-13 years

Exclusion Criteria:

* any musculoskeletal conditions that affect balance previous surgeries that affecting balance
Observational Study on the Use of Ivermectin as an Outpatient Treatment Option for COVID-19

Ivermectin is currently being utilized by a number of physicians in the local area. My objective will be to enroll these patients at the time of their evaluation for COVID-19 infection and to follow their progress through their recovery.

Patients at local physician clinics as well as my own clinic will be enrolled at the time they are evaluated for having COVID-19. Patients enrollment will be voluntary and based upon their request for treatment with Ivermectin. These patients will be questioned on symptoms and the timing of those symptoms in detail. They will then be followed throughout their treatment course to evaluate their recovery experience. Detailed accounts of their symptoms and their resolution will be followed. The study patients will stop being followed when they are either admitted to the hospital or are deemed to be symptom free. Any other medications prescribed to the patients will also be tracked. Medical histories will be taken and documented to make comparisons at the end of the study. Those patients not requesting Ivermectin will also be followed for comparisons at a later date.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 12-110 years old
* Has a recently completed COVID test
* Symptomatic and seeking treatment
* Willingness to participate and have follow-up
* Able and willing to take medications and treatment suggestions from the physician

Exclusion Criteria: Lack of symptoms, uncertain of COVID-19 status, outside of age limits for treatment

* No recent COVID test results
* Asymptomatic, even if COVID positive
* Outside of acceptable age range
* Meets criteria for hospital admission
* Unwilling to participate in trial study or have follow-up
A Pilot Study to Characterize Bile Acid Metabolism and Dysbiosis in Primary Sclerosing Cholangitis

The goal of this study is to assess if oral vancomycin can restore the normal bile acid metabolism of people with Primary Sclerosing Cholangitis and Inflammatory Bowel Disease. Study participants will provide blood and stool samples in order to evaluate the bile acid metabolism before a short course of vancomycin and then again after to assess for change. The investigators will also assess the blood and stool of healthy people, and people with IBD (without PSC) as a control group.

Primary Sclerosing Cholangitis (PSC) is a chronic inflammatory and fibrotic disease of the intra and extrahepatic ducts of unknown etiology that predominately occurs in people with Inflammatory Bowel Disease (IBD). One hypothesis is that altered microbiome (bacteria in the gut) in people with IBD are responsible for the inflammation in the liver seen in PSC. Bile acids (BAs) represent a unique mechanism of communication between the host and intestinal microbiome and the liver. Synthesized in the liver, bile acids are metabolized by intestinal bacteria hydroxylases to secondary BAs which then re-enter the portal circulation. Altered metabolism of BAs has been associated with gallstones and colorectal cancer and is hypothesized to play a role in the inflammatory response of certain disease such as IBD and PSC.

IBD has been associated with impairment of bile acid (BA) metabolism. In addition BAs play a role in regulating bacterial growth of the intestine and thus have an effect on the integrity of the intestinal mucosa, which is an essential component of IBD. Perturbations in this system could increase bacterial translocation into the portal system due to loss of protective mucosal factors or bacterial overgrowth.

The overall goal of this study is to assess the changes in BAs metabolism following administration of oral vancomycin. The investigators will also describe the relationship of the intestinal microbiome and BA metabolism in PSC/IBD.

Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of PSC made by typical clinical, radiographic and biochemical criteria.
* Diagnosis of PSC \> 3 months

Exclusion Criteria:

* Antibiotic use within 30 days of initial study visit
* Probiotic use within 30 days of initial study visit
* Extensive ileal disease
* Severe of fulminant IBD
* Diabetes and/or metabolic syndrome
* Chronic disease state deemed unacceptable for the study per investigator review
* Decompensated Cirrhosis
* Females who are pregnant or breastfeeding
The Relationship Between Covid-19 and Pneumothorax in Patients Hospitalized With Covid-19 During the Pandemic

It is aimed to examine the retrospective features of covid-19 patients followed in our hospital with pneumothorax.

It is aimed to examine the retrospective features of covid-19 patients followed in our hospital with pneumothorax. The files of covid-19 patients with pneumothorax were reviewed retrospectively. The radiological records and treatment protocols of the patients were reviewed. The results were evaluated in terms of its relationship with pneumothorax.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years
* covid-19 patient
* having a diagnosis of pneumothorax
* PCR test positive and lung tomography pneumonic involvement

Exclusion Criteria:

* PCR test negative