cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Evidence-Based PTSD Treatment Via Prebiotic Supplementation

Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder, which results from exposure to traumatic events. Veterans are more than twice as likely to suffer from PTSD compared to civilians. Current interventions for the treatment of PTSD are evidence-based psychotherapies, such as Cognitive Processing Therapy (CPT). Therefore, we plan to compare Cognitive Processing Therapy (CPT) with and without a novel prebiotic bar designed to beneficially modulate the microbiota to determine the utility of this combined approach to positively impact PTSD symptoms. We will conduct a 12-week randomized, double-blind, placebo-controlled, cross-sectional trial in veterans with PTSD. Participants will be randomized to receive CPT + prebiotic or CPT + placebo. They will be provided a supply of prebiotic or non prebiotic bars for 12 weeks. At three different time points, participants will complete questionnaires and complete questionnaires and produce a stool sample ( weeks 1,2, and 12). All participants will be recruited from the two-week in-person Intensive Outpatient Program (IOP) at the Rush Road Home Program, where they will be receiving CPT.


Eligibility Criteria:
Inclusion Criteria:

* Veterans who are participating in the Rush Road Home Program 2-week Intensive Outpatient Program (IOP) and have the ability to consent.
* Ability and willingness to consume up to two prebiotic bars daily and collect stool samples.

Exclusion Criteria:

* Active suicidality or homicidality, current engagement in significant non-suicidal self harm, history of mania or psychosis, current eating disorders, and/or current substance use that would require medical observation if discontinued.
* Gastrointestinal disease: (1) prior intestinal resection, (2) history of GI disease (except for hiatal hernia, nonproton pump inhibitor requiring gastroesophageal reflux disease, or hemorrhoids), (3) known renal disease or abnormal liver function, (4) antibiotic use within the previous 12 weeks, (5) a plan to have a major change in dietary habits during the study.
* Allergy to almonds, flax seed or coconuts
Does Atorvastatin Reduce Ischemia-Reperfusion Injury in Humans in-Vivo?

To study the impact of 3 day exposure to atorvastatin 80mg on Annexin A5 targeting after ischemic exercise in the non-dominant forearm.

3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (also known as statins) have been found to reduce cardiovascular events. This protective effect has been traditionally explained by lowering plasma cholesterol and subsequent reduced progression of atherosclerosis. However in animal experiments statins have also shown the ability to induce pharmacologic preconditioning and thereby reduce infarct size. This effect contributes to the beneficial effect of statins on reducing of cardiovascular events. In order to differentiate between these two mechanisms of protection we will study the effect of atorvastatin on ischemia reperfusion damage after a short exposure to atorvastatin, before the lipid lowering effect of atorvastatin becomes apparent.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Age 18-50 years
* Informed consent
* Physical able to perform ischemic exercise

Exclusion Criteria:

* History of any cardiovascular disease
* Hypertension (in supine position: systole \> 140 mmHg, diastole \> 90 mmHg)
* Diabetes mellitus (fasting glucose \> 7.0 mmol/L or random glucose \> 11.0 mmol/L)
* Hyperlipidaemia (fasting total cholesterol \> 5.5 mmol/l)
* Alanine-Amino-Transferase (ALAT) \>90 U/L
* Creatinine Kinase (CK) \>440 U/L
* Drug or alcohol abuse
* Concommitant chronic use of medication
* Administration of radioactivity in research setting during the last 5 years
* Participation to any drug-investigation during the previous 60 days as checked with VIP check according to CRCN standard procedures
Effect of Pilates Training on Cognitive Functions in Patients With Stroke

The purpose of the present study is to investigate the effect of pilates training on cognitive functions in patient with stroke

Stroke remains a primary cause of morbidity throughout the world mainly because of its effect on cognition. Individuals can recover from physical disability resulting from stroke, but might be unable to return to their previous occupations or independent life because of cognitive impairments.

Post-stroke cognitive impairment is not a unitary syndrome but incorporates a variety of deficits in multiple domains such as attention, executive functions , memory, language and visuoperceptual abilities. Cognitive impairment occurs in up to 64% of people who have had a stroke and has been associated with a 3-fold increase in risk for mortality, institutionalization and decreased instrumental activities of daily living function.

Pilates training was developed by Joseph H. Pilates .It belong to a group of so-called Body-Mind Exercises, where the focus is on controlled movement, posture, and breathing .Pilates (pronounced: puh-lah-teez) improves mental and physical well-being , increases flexibility through controlled movements done as mat exercises.

Pilates training improve cognitive functions through increasing blood and oxygen flow to the brain , support neuronal survival in the developping brain ,Generate new neurons ,Provides mood enhancement ,Increases neurotransmitters and Neurotrophins assure the survival of neurons in areas responsible for learning, memory and higher thinking.

Eligibility Criteria:
Inclusion Criteria:

1. Forty patients with stroke (hemiparesis) with muscle power at least grade 3 according to manual muscle testing scale (Appendix VI) from both genders their ages will be ranged from 50-65years old.
2. Patients with ischaemic stroke in the domain of the carotid system.
3. All patients have mild cognitive deficits in domains ( memory, attention, orientation, perception and executive skills) with score \<25 according to Montreal Cognitive Assessment (Appendix IV).
4. Duration of illness not less than six months and not more than 18 months.
5. Spastcity grade (1) according to the Modified aschworth scale (MAS) ( Bohannon and Smith, 1987)(Appendix III).
6. All patients in the study should be ambulant independently.
7. Medically and psychologically stable patients.
8. All patients will approve and sign a consent form (Appendix I).
9. All patients are litrate.

Exclusion Criteria:

1. Patients with hemiparesis with motor weakness or incoordination.
2. Patients with cardiovascular problems (uncontrolled hypertension ,unstable angina ,significant coronary heart disease and or congestive heart failure).
3. Patients with dementia with score \<3 according to Mini cog test(Appendix V). .
4. Patients with Musculoskeletal problems (deformity or contracture).
5. Medically unstable and uncooperative patients.
6. Patients with Moderate and severe obesity (BMI≥ 35 kg/m2).
7. Patients with depression with score \> 8 according to Hamilton depression rating scale (HAM-D) (Appendix VII).
Natural Killer Cells Reconstitution Kinetics Post Haploidentical Transplantation

Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution.

Patients with hematological malignancies suitable for allo-HSCT but without HLA-identical related or unrelated donors were candidates for the HLA-haploidentical HSCT. Patients undergoing haploidentical allo-HSCT will be prospectively enrolled exploring the NK cells phenotype and functional reconstitution. Peripheral blood will be collected by day15, 30, 60, 90, 180, and 1 year post transplantation.

Eligibility Criteria:
Inclusion Criteria:

* AML or MDS or CML or ALL undergoing haploidentical stem cells transplantation

Exclusion Criteria:

* NR or refractory AML/ALL before transplantation donors from mother or collateral related
A Clinical Study of SPH6516 Tablets in the Treatment of Advanced Solid Tumors.

To evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SPH6516 tablets in the treatment of advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Advanced solid tumors;
2. The ECOGscore is 0 to 1.
3. Expected survival ≥3 months.
4. Good organ function before first use of the investigational drug.
5. Any toxicity associated with previous antitumor therapy must have returned to ≤ grade 1.
6. Voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent in person.

Exclusion Criteria:

1. Subjects who have received certain treatment in the prescribed period prior to their first medication;
2. Subjects who have undergone major surgery within 6 weeks before the first medication, or who plan to undergo major surgery within 12 weeks after the first medication;
3. Subjects who have participated in any other clinical trials and received treatment within 4 weeks prior to the first medication;
4. Subjects with third space fluid accumulation that cannot be controlled by drainage or other methods; Subjects with factors affecting drug administration and absorption;
5. Subjects with allergic constitution or a history of severe allergies;
6. Subjects with active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, or a history of immunodeficiency;
7. Subjects with a history or evidence of high risk cardiovascular disease;
8. Subjects with severe lung disease;
9. Pregnant and lactating female subjects; Female subjects of childbearing age or male subjectswith fertile partners who were unwilling to take effective contraceptive measures throughout the entire trial period;
10. Subjects with a clear history of neurological or psychiatric disorders;
11. Other situations in which the investigator did not consider it appropriate to participate in the study.
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma

Selective laser trabeculoplasty (SLT) is a well-recognized way to lower eye pressure in treatment of glaucoma. This treatment is performed for 180 degrees or 360 degrees, and studies at academic centers have shown mixed results when comparing the success rates of 180 degrees or 360 degrees. Both protocols are now typically done by comprehensive ophthalmologists. However, there is no data that compares success rates of 180 degrees and 360 degrees in the community setting.

This study is designed as a prospective evaluation of the two treatment algorithms for SLT by measuring intraocular pressure (IOP) after treatment. The hypothesis is that 360 degrees of SLT will produce a greater reduction in IOP than 180 degrees of SLT at 3 months follow up.

Eligibility Criteria:
Inclusion Criteria:

* patients who have been diagnosed with open-angle glaucoma including ocular hypertension, pseudoexfoliation and pigment dispersion syndrome
* greater than 18 years of age
* initial intraocular pressure (IOP) of ≥ 21 mmHg

Exclusion Criteria:

* prior medical or laser therapy to lower IOP
* previous incisional glaucoma surgery before the study period
Standard Operating Procedures for Anti-HPV (Human Papillomavirus) Antibody Detection in First-void Urine (AB-SOP Study)

The aim of the study is to develop robust analytical protocols for first-void urine sample preparation and antibody assays to monitor natural and/or vaccine induced immunity against HPV (Human Papillomavirus).

In total 57 women will be included in this trial: 38 vaccinated with an prophylactic HPV vaccine and 19 not vaccinated with a prophylactic HPV vaccine. These women are asked to collect a first-void urine sample with the Colli-PeeTM device (Novosanis). Hereafter, a blood sample of 5-10 cc is collected. The collected urine and blood samples will be used for the development and optimisation of robust analytical protocols for sample preparation and antibody assays.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18-26 year
* Cases (n=38): healthy women, fully vaccinated, i.e. receiving all three doses of the bivalent (Cervarix®) or quadrivalent (Gardasil®) HPV vaccine (according to the KCE (Belgian Knowledge Centre for Health) recommendations: age at first vaccination between 10-25 years for the bivalent and 9-26 years for the quadrivalent vaccine).
* Cases should be able to prove their vaccination (brand and schedule) with an official document.
* Control group (n=19): healthy women, self-reported to be not previously vaccinated with a single dose of any prophylactic HPV vaccine available (Gardasil®, Cervarix®, Gardasil-9®)
* Signing informed consent form (ICF).
* Giving consent to the research team (CEV) to contact his/her general practioner and/or gynaecologist to access details of the participants HPV vaccination (schedule) and results of cervical smears/cytology, HPV tests, colposcopy, and biopsy (included in ICF).

Exclusion Criteria:

* Participating in another clinical study at the same time of participating in this study.
* Not able to understand the information brochure/what the study is about
* Anything in the opinion of the investigator that would prevent volunteers from completing the study or put the volunteer at risk.
Physical Activity, Sports and Health in Adults With Intellectual Disabilities

Currently, there is a paucity of quality research within the field of health science with a focus on persons with intellectual disabilities, and especially how longer lasting periods of varied physical activity affects the target group. There is a lack of insight, in how persons with intellectual disabilities learns and retains movement skills. Thus, the research group behind this project will investigate the following research questions:

1. Does 40 weeks of intense and varied sports and physical activities as an intervention lead to positive changes in health status for adults with intellectual disabilities?
2. Can lasting effects be measured three and six months after the intervention?
3. Does the intervention improve the motor competences for the participants?
4. How does defined groups of adult persons with Down syndrome and Cerebral Palsy learn and retain a new motor skill?


Eligibility Criteria:
Inclusion Criteria:

* Presence of an intellectual disability

Exclusion Criteria:

* Participants under guardianship
* Unable to give informed consent to participate on their own
Evaluation of Penetration of Ceftobiprole Into Soft Tissue Determined by Microdialysis in Healthy Volunteers

The primary objective of this study is to measure the penetration of ceftobiprole into subcutaneous (s.c.) adipose tissue and skeletal muscle and to determine the concentration over time of ceftobiprole in these tissues and in plasma after administration of a single intravenous (i.v.) infusion (directly into the vein) of ceftobiprole 500 mg administered over 2 hours. The secondary objective was to further assess the safety and tolerability of ceftobiprole after a single i.v. infusion.

This is a single-center, open-label (all patients involved know the identity of the drug), single-arm, nonrandomized study of ceftobiprole in healthy men and women. The study is conducted in 2 parts: a pilot study and a main study. Each study (i.e. the pilot study and the main study) consists of 3 phases: a pretreatment phase that includes up to a 21-day screening period, an open-label treatment phase (1 day in the pilot study and 2 days in the main study), and a posttreatment phase that included the end of study evaluations and follow-up study visit or telephone contact planned for 1 to 2 weeks after discharge from the study unit. Serial blood and dialysis samples will be collected at specified time points from predose through 24 hours after the start of the infusion for estimation of ceftobiprole and ceftobiprole medocaril concentrations. Additional samples will be collected for measurement of protein binding. The study will include the following evaluations of safety and tolerability: adverse events, clinical laboratory tests (including hematology, serum chemistry, and urinalysis), electrocardiogram (ECG), vital signs, physical examination, serology, pregnancy tests, urine drug screen, and alcohol breath test. In the pilot study, Ceftobiprole will be locally administered via a microdialysis probe at a concentration of approximately 30 µg/mL for 60 minutes. In the main Study, each volunteer will receive ceftobiprole locally via the microdialysis probe. After the washout period determined by the pilot study, each volunteer will receive a single 2-hour i.v. infusion of ceftobiprole.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI between 18 to 29 kg/m2
* Nonsmoker
* Normal renal function

Exclusion Criteria:

* History of gastric or duodenal ulcer
* History of allergies or hypersensitivity (including penicillin, cephalosporins, or other ß-lactams or quinolones)
* Hypersensitivity or intolerance to heparin
* History of drug or alcohol abuse
Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study

The purpose of this study is to determine if atorvastatin (Lipitor) reduces the occurence of abnormal heart rhythm (atrial arrhythmia) following non cardiac thoracic surgery.

The incidence of atrial arrhythmia after thoracic, non-cardiac procedures is exceedingly common and has been reported to occur in between 10-39% of patients. It has been shown to increase majority morbidity and also delay hospital discharge. Recent studies suggest that one week of pre-operative atorvastatin may reduce the incidence of post-operative atrial arrhythmia in patients who undergo cardiac surgery and a multi-institutional study is currently underway to further examine this concept. However, there are no published prospective randomized studies to date that have evaluated the effectiveness of atorvastatin to reduce atrial arrhythmia in patients who undergo thoracic, non-cardiac operations such as esophagectomy or pulmonary resection. The object of this study is to determine if atorvastatin reduces the incidence of atrial arrhythmia (atrial fibrillation or flutter) following non-cardiac thoracic surgery, specifically pulmonary resections.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective non-cardiac thoracic surgery requiring thoracotomy for resection

Exclusion Criteria:

* Past medical history of pacemaker implantation
* Pregnancy or lactating
* History of Atrial arrhythmia within the past year
* Elevated liver enzymes pre-operatively
* Past medical history of any liver disease or history of liver transplantation
* Use of statins or any anti-arrhythmics (including beta-blockers, calcium channel blockers, digoxin) within 3 months prior to surgery
* Pre-op EKG showing atrial arrhythmia
SCT-I10A Plus SCT510 Versus Sorafenib as First-Line Therapy for Advanced Hepatocellular Carcinoma

The purpose of the study is to assess the safety and effectiveness of SCT-I10A in combination with SCT510 in patients with HCC who have not received prior systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have a diagnosis of HCC not suitable for radical surgery and/or local treatment，or progressed after surgery and/or local treatment.
* No prior systemic therapy for HCC(End of postoperative adjuvant chemotherapy for more than 6 months allowed).
* Child-Pugh ≤7 , no history of hepatic encephalopathy.
* Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.
* At least one measurable lesion based on Recist1.1
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
* Adequate hematologic and organ function.

Exclusion Criteria:

* Local treatment or surgery for liver lesions within 4 weeks.
* Prior liver or other organ transplantation.
* Active Central nervous system (CNS) metastasis or leptomeningeal metastases.
* Gastrointestinal perforation and/or fistula or intraperitoneal abscess within 6 months prior to the start of study treatment.
* Hemorrhage tendency or high-risk for bleeding , severe coagulation disorders.
* Active known, or suspected autoimmune disease.
* Any condition that is not suitable for participate in this study as determined by investigator.
Atazanavir Twice Daily

The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg, given once daily.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects between the ages of 18 to 45 years old with a BMI of 18 to 30 kg/m2
Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

This study will compare insulin lispro protamine suspension (ILPS) and insulin glargine in combination with the patient's oral diabetes medications and exenatide, for their ability to control blood sugar in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Must have type 2 diabetes
* Must be at least 18 years of age and less than 75 years of age
* Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months
* Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone
* Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%

Exclusion Criteria:

* Must not have used insulin on a regular basis during the past 2 years
* Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months
* Must not have had more than one episode of severe hypoglycemia in the past 6 months
* Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease
* Must not be pregnant or intend to get pregnant during the course of the study
Home Visits to Optimize Medical and Educational Success Among Sacramento Schoolchildren With Asthma

This study will establish a multi-disciplinary home visitation team consisting of a medical provider and school teacher or staff member, and will evaluate whether a series of visits from this team will help decrease school absenteeism among children with asthma.


Eligibility Criteria:
Inclusion Criteria:

* Students in elementary school (K-6) in the Sacramento City Unified School District
* Identified as at risk for chronic absenteeism based on previous year and/or first 8 weeks of school year
* Have a current diagnosis of asthma

Exclusion Criteria:

* Underlying chronic conditions such as cystic fibrosis, chronic lung disease with oxygen dependence, immunodeficiency syndromes