cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Mobile Phone App for Veterans With PTSD

The purpose of this study is to evaluate a mobile phone app designed to help Veterans with PTSD. Participants in this study will be randomized to receive one of 2 possible mobile phone apps. The term "randomized" means that which app a participant receives will not be based on any characteristic or behavior of the participant, but will be determined solely by chance like a flip of a coin.

Participants will receive access to the mobile app "PTSD Coach". Participants will be randomized (by computerized coin flip) to one of two versions of the mobile app. All versions of the app will provide comprehensive information and tools for managing trauma symptoms, but one version of the app will provide personalized, confidential coaching messages delivered by either a Veteran peer or clinical psychologist. Participants will be asked to complete an online survey before using the mobile phone application and again 8 weeks later. Participants will be provided with the option to complete a telephone interview after 8 weeks of using the mobile phone application. To be eligible, participants must be a U.S. military Veteran, age 18 or older, have received a previous diagnosis of PTSD, and own an iPhone or iPad device.

Eligibility Criteria:
Inclusion Criteria:

* U.S. military Veteran
* age 18 or older
* previously diagnosed with PTSD
* own an iPhone or iPad device

Exclusion Criteria:

* no previous history of PTSD
Drug-Drug Interaction Study to Assess the Effects of Multi Dose Clopidogrel on the Pharmacokinetics of Single-Dose K-877 in Healthy Adult Volunteers

The primary objective of this study is to assess the effects of clopidogrel on the PK of K-877 in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent before any study-specific evaluation is performed;
* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive at screening;
* Subject has a BMI of 18 to 30 kg/m², inclusive;
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges, or results that do not show clinically significant abnormalities, as judged by the Investigator at screening and check-in;

Exclusion Criteria:

* Subject is a woman who is pregnant or breastfeeding;
* Subject has clinically significant abnormalities in the screening or check-in assessments;
* Subject has current or history of clinically significant coagulation, bleeding, or platelet disorders;
* Subject or a family member of the subject has a history of coagulation or bleeding disorders or reasonable suspicion of vascular malformations, including aneurysms;
Effect of Neoadjuvant Radiation on Tumor Infiltrating T-cells by Low Dose Radiation in Colorectal Liver Metastases

The efficiency of T cell based immunotherapies is affected by the insufficient migration and activity of tumor specific effector T cells in the tumor. Aim of this phase I/II clinical trial is to evaluate whether a neoadjuvant, low dose radiotherapy can improve T cell connected anti tumor immune response in colorectal liver metastases.

The primary endpoint is the number of tumor infiltrating T cells. Furthermore the T cell activity in situ, the number of regulatory T cells and the frequency of tumor reactive T cells in the blood and bone marrow will be examined.


Eligibility Criteria:
Inclusion Criteria:

* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent (must be available before enrolment in the trial)
* Age ≥ 50 years
* Radiological urgently suspected colorectal liver metastasis

Exclusion Criteria:

* second malignancy
* Pregnancy and lactation
* no prior liver radiation
* liver metastasis must be resectable
Haploidentical Stem Cell Transplantation for Children With Acquired Severe Aplastic Anemia

Rationale: Fludarabine, cyclophosphamide, anti-thymocyte globulin and low-dose total body irradiation (LD-TBI) may induce the engraftment cross the immunologic barrier in the setting of HLA-haploidentical allogeneic hematopoietic cell transplantation. In addition, depletion of CD3 cells may contribute to prevent developing severe acute graft versus host disease (GVHD) in haploidentical transplantation.

Purpose: Phase II trials to evaluate the efficacy of haploidentical stem cell transplantation with fixed dose of T cells after in vitro T cell depletion using CD3 monoclonal antibody for children with acquired severe aplastic anemia


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of life-threatening marrow failure (severe aplastic anemia) of nonmalignant etiology meeting 2 of the following criteria:

  * Granulocyte count \< 500/mm3,
  * Corrected reticulocyte count \< 1%,
  * Platelet count \< 20,000/mm3
* No HLA-identical family member or closely matched (8 of 8 HLA-locus match) unrelated marrow donor available
* HLA-haploidentical related donor available

Exclusion Criteria:

* Paroxysmal nocturnal hemoglobinuria or Fanconi anemia
* Clonal cytogenetic abnormalities or myelodysplastic syndromes
* Active fungal infections
* HIV positive
* Severe disease other than aplastic anemia that would severely limit the probability of survival during the graft procedure
* Pregnant or nursing
Phase 1 Study of BPI-442096 in Advanced Solid Tumor Patients

A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-442096, a SHP2 inhibitor, in patients with advanced solid tumors.

The first-in-human (FIH) study of BPI-442096 will be an open-label, non-randomized, Phase 1 study utilizing a modified "3+3" dose escalation followed by an expansion phase in patients with KRAS G12 mutation, class-3 BRAF mutation, NF1 LOF mutation or RTK mutation, amplification or rearrangement advanced solid tumors. The primary objective is to determine safety and tolerability of BPI-442096, the MTD and RP2D. The secondary objectives are to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile, preliminary anti-tumor activity of BPI-442096.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent;
* Age ≥18 and ≤75 years, male and female patients;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
* Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC patients), who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
* Dose expansion phase: histologically or cytologically confirmed locally advanced non-small cell lung cancer, pancreatic cancer, colorectal cancer or other diagnosed solid tumor patients (excluding HCC patients), who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
* Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1 required for dose expansion phase;
* Dose expansion only: Patients must have confirmation of tumour mutation status (including KRAS G12, Class-3 BRAF, NF1 LOF mutations, RTK mutations, amplifications or rearrangements).
* Adequate organ function;

Exclusion Criteria:

* Patients who have previously received a SHP2 inhibitor;
* Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer;
* Patients with severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, cardiac disease, bleeding or embolic disease, infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;
* Pregnancy or lactation;
* Other conditions considered not appropriate to participate in this trial by the investigators.
Surgical Removal of Visceral Fat Tissue (Omentectomy) Associated to Bariatric Surgery: Effects on Insulin Sensitivity

The intraabdominal fat is associated with insulin resistance, a condition that is in the basis of diabetes, metabolic syndrome and some cardiovascular diseases. It is not clear whether it is the origin of it or a surrogate marker only. We intend to compare the effects of bariatric surgery with versus without omentectomy in morbidly obese people intended to go through bariatric surgery, accessing insulin sensitivity by metabolic tests.

If the visceral fat is causative of insulin resistance, its surgical removal (omentectomy) might lead to improvement of insulin action, as seen in animal studies and in one study with morbidly obese human volunteers.

In order to verify a potential additional benefit of omentectomy combined to Roux-en-Y silastic ring gastric bypass, insulin sensitivity will be studied by the gold-standard test, euglycemic-hyperinsulinemic clamp, since early postoperative follow-up (before significant weight variation), compared to a control group of bariatric surgery (same technique) alone. The variables will be analyzed in the post surgical evolution for correlation to metabolic changes: adiposity-related hormones and cytokines; lipid profile and other cardiovascular risk factors; molecular expression of biopsied subcutaneous adipocytes in vitro; anthropometrics; ultrasonography of abdominal subcutaneous and intra-abdominal fat depots and carotid intima-media thickness (preclinical atherosclerosis evaluation).

Eligibility Criteria:
Inclusion Criteria:

* Age between 21 and 50 years.
* Female sex.
* BMI between 40 and 50kg/m2.
* Metabolic syndrome (NCEP/ATP III criteria).

Exclusion Criteria:

* Weight variation \>5% within 3 months prior to preoperative tests.
* Use of antidiabetic medications within 3 months prior to preoperative tests.
* HbA1c \>8%.
* Use of systemic corticosteroids for longer than 1 week within 3 months prior to preoperative tests.
* Hepatic cirrhosis, renal failure or any clinical condition (other than obesity) recognized as impairing insulin sensitivity.
* Present Smoking.
Referral Recommendations for Axial Spondyloarthritis

The purpose of this study is to determine which of the proposed screening parameters or which combination of screening parameters perform best in daily clinical practice for making the diagnosis of axial Spondyloarthritis (SpA)in patients with chronic low back pain.

Ankylosing spondylitis (AS) and its early form accounts for up to 5% of all patients with chronic back pain. Shortening the delay of 5-10 years between first symptoms and making a diagnosis of AS has become a challenge especially because effective treatments have become available. Easy to apply referral parameters for physicians in primary care may contribute to make the diagnosis earlier.

Methods: Orthopedists and primary care physicians were offered to refer patients with i) chronic low back pain (duration \>3 months) and ii) onset of back pain at an age \< 45 years to a specialized rheumatology outpatient clinic for further diagnostic work-up if at least one of the following screening parameters was present: 1) inflammatory back pain (IBP), 2) positive HLA-B27, 3) sacroiliitis as detected by imaging. The final diagnosis was made according to expert opinion.

It was analyzed, which parameters or combination of parameters performed best in making a diagnosis of axial SpA.

Eligibility Criteria:
Inclusion Criteria:

* chronic back pain with a duration of more than 3 months
* onset of back pain before age of 45 years

Exclusion Criteria:

* age younger than 18 years
Negative Pressure Wound Therapy After Cesarean Delivery

This study is aimed at determining whether or not the use of a wound suction device placed on the cesarean incision instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The study will first look at the infection and wound complication rate in women 6 months prior to the start date of the study by reviewing charts of women who have undergone a cesarean section. The study involves placing a single use, portable wound vacuum over the cesarean section incision and keeping it in place for 72h. The investigators will then compare the rates of wound infection and wound complications between these two groups.

It is our hypothesis that negative pressure wound systems will decrease the wound infection and complication rate in this high risk population.

Infectious complications have been found to be five times higher in women undergoing a cesarean delivery compared to a vaginal delivery. Known risk factors for wound complications are obesity, premature rupture of membranes, diabetes mellitus, hypertensive disorders, emergency cesarean delivery, twin delivery, chorioamnionitis, increased surgical blood loss and preeclampsia.

This study is aimed at determining whether or not the use of a suction device placed on the wound instead of a standard sterile dressing will decrease the prevalence of wound complications and wound infections in women at high risk for post operative complications. The investigators will compare the results from the participants of this study to an existing data set of historical controls who underwent cesarean delivery. The study involves placing a single use, portable negative wound pressure system kept in place while in the hospital after surgery (on average 48-72 hours) in women who meet criteria for increased risk of wound complications. The investigators will then compare the rates of wound infection and wound complications between these two groups.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Having a cesarean delivery
* Has one or more of the following conditions:
* BMI \> 30
* Anemia
* Preeclampsia (sever or mild)
* Hemolysis, elevated liver enzymes and low platelets (HELLP)
* Urgent procedure
* Rupture of membranes prior to surgery for \> 4 hours
* Chorioamnionitis
* Hypertension
* Diabetes (Gestational or pre-gestational)
* Dense adhesive disease

Exclusion Criteria:

* Age \< 18 years old
* Unable to give informed consent
Intermittent Boluses Versus Infusion of Propofol During Gastroscopy

It is unclear whether continuous infusion or intermittent bolus injection of propofol is better for achieving adequate sedation during a standard upper endoscopy. The study aimed to compare the efficacy and safety of continuous infusion and intermittent bolus injection of Propofol (Diprivan) during a standard upper endoscopy. In this prospective study, patients will be randomly assigned to undergo a standard upper endoscopy with either continuous infusion (CI group) or intermittent bolus injection (BI group) of Propofol (Diprivan) administered by an anesthesiologist. The primary outcome will be to assess the quality of sedation by the endoscopist (VAS). In addition to other sedation-related parameters that will include sedation induction time (minutes), total dose of propofol (mg), recovery time (minutes) using Aldrete score, any involuntary patient movement, and adverse events.

Patients of both genders, aged between 18 and 85 years old and referred to standard upper endoscopy at Luzmila Hospital will be included in the study. Patients who are pregnant, have known allergies to the drugs used or a history of sedation-related complications (i.e., severe paradoxical response, hypoxemia, bradycardia, and hypotension) or gastrectomy, are American Society of Anesthesiologist (ASA) class ≥ IV (11), or are unable to provide informed consent will be excluded from participating in the study. The patients undergoing a standard upper endoscopy will be randomly assigned to either continuous infusion (CI group) of propofol (Diprivan) with induction using benzodiazepine (2 mg Dormicum i.v.) or only intermittent bolus injection (BI group) of propofol (Diprivan) infused by an anesthesiologist. BI was defined by intermittent use of 20 mg propofol (Diprivan) boluses on demand, with a minimum period of 30 seconds between boluses to evaluate the effect of the drug. CI was defined by continuous propofol (Diprivan) infusion at a 3 mg/ kg/h rate.

The anesthesiologist will follow up the patient during the first observation period, the average time spent in the recovery area and register the requied data during the procedure using Aldrete score (a post anesthesia recovery score where a minimum score of 8 is required for discharge).

The patients' identities will be coded and the data will be kept confidential. The study protocol will be performed according to the Decalrations of Helsinki and will be applied for approval by the Institutional Review Board at Al-Balqa Applied University. Written informed consent was obtained from all patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders
* Age between 18 and 85 years old
* Referred to standard upper endoscopy at Luzmila Hospital

Exclusion Criteria:

* Patients who are pregnant,
* Known allergies to the used drugs
* History of sedation-related complications (i.e., severe paradoxical response, hypoxemia, bradycardia, and hypotension)
* Previous history of gastrectomy,
* Patients are American Society of Anesthesiologist (ASA) class ≥ IV ,
* Patients are unable to provide informed consent
PK Study of Gefurulimab SC in Healthy Chinese Adult Participants

The primary objective of this study is to characterize the PK properties of a single dose of gefurulimab in healthy Chinese participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be 18 to 45 years of age, inclusive, at the time of signing the informed consent.
* Body weight within ≥ 45 kg to \< 110 kg and BMI within the range 18 to 30 kg/m2 (inclusive) at Screening and Admission (Day -1).
* Participants who are healthy as determined by medical evaluation with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation.
* QTcF ≤ 450 msec for male participants and ≤ 460 msec for female participants at Screening and prior to dosing on Day 1.
* Documented vaccination against N meningitidis serotypes A, C, W-135, Y at least 28 days and not more than 3 years prior to dosing on Day 1.

Exclusion Criteria:

* History of any Neisseria meningitidis infection.
* History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders.
* Abnormal blood pressure as determined by the Investigator.
* History of latent or active TB (Tuberculosis) or exposure to endemic areas.
* Active systemic bacterial, viral, or fungal infection within 14 days prior to dosing.
* History of latent or active TB or exposure to endemic areas within 8 weeks prior to the Screening Visit confirmed by QuantiFERON®-TB test.
* Significant allergies to humanized biologics.
* Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
* History of clinically significant allergic reaction (eg, anaphylaxis or angioedema) to any product (eg, food, pharmaceutical).
* History of allergy or intolerance to penicillin or cephalosporin.
* Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
* Current or chronic history of liver disease.
* Evidence of human immunodeficiency virus (HIV) infection (positive HIV type 1 or type 2 antibody).
* Evidence of hepatitis B infection (positive hepatitis B surface antigen \[HBsAg\] or positive total hepatitis B core antibody \[HBcAb\] with negative surface antibody \[anti-HBs\]), or hepatitis C viral infection (positive HCV RNA).
* Female participants who have a positive pregnancy test at Screening or Admission.
* Positive prestudy drug/alcohol screen; positive result may be repeated once.
Smoking Cessation After Hospitalization for a Cardiopulmonary Illness

Smoking-related cardiopulmonary diseases account for a large number of hospital admissions. We investigated the efficacy of hypnotherapy as an aid to a counseling-based smoking cessation program in improving quit rates of hospitalized smoking patients at 12 and 26 weeks after hospital discharge. We compared outcomes with hospitalized patients who received more conventional therapy, namely nicotine replacement therapy, or patients who decided to quit on their own. We also compared smoking cessation rates at 12 and 26 weeks after hospitalization among patients admitted with a cardiac or a pulmonary diagnosis.

Hospitalized patients with a cardiopulmonary diagnosis who were contemplating quitting were recruited into 4 groups: Hypnotherapy, Nicotine replacement therapy (NRT), both hypnotherapy and NRT, and self-quit group. All patients received self-help brochures and in-hospital counseling. Intervention groups received more extensive counseling, free NRT supply for a month and/or a 90 minute hypnotherapy session within 2 weeks of discharge. They also had follow up telephone counseling at 1,2,4,8 and 12 weeks after discharge. 7 day prevalence of tobacco abstinence rates at 26 weeks after hospitalization were verified by self report and urinary Cotinine levels.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients with a Cardiopulmonary admission.

Exclusion Criteria:

* Terminal illness, history of Serious Psychiatric illness or substance abuse, Pregnancy, Cognitive or language barriers.
Research Proposal of New Technologies and Standardization of Physiotherapy Stroke Rehabilitation

One of the main goals of physiotherapy in stroke rehabilitation is to maximize walking ability of patients as soon as possible. Traditionally, intervention selection and application of neuroplasticity to stroke patients depends on personal preference and experience of therapists. Recent development of technologies may provide more accessible, efficient, objective, intensive and predictive methods compared to traditional practices in facilitating the process of recovery after brain injury and standardizing stroke rehabilitation programs.

A clinical quality improvement program named Accelerated Stroke Ambulation Program (ASAP) was started in Stroke Rehabilitation Program Tai Po Hospital by Physiotherapy Department since 2019, pilot period from October 2019 to September 2020 and execute as standard practice afterward.

The goal of ASAP was to facilitate maximal walking ability of stroke patients by standardized application of modern technologies. ASAP features standardized functional assessment, standardized intensive early ambulation with modern technologies such as Knee-Ankle-Foot Orthoses, Lower Limb Robotic-Assisted Gait Training and Video-Guide Training. In order to monitor the progress of each patient proactively, Stroke Registry and Reference Modified Rivermead Mobility Index (MRMI) Gain were developed. Stroke Registry was a longitudinal stroke rehabilitation database to monitor patients' functional outcome and therapists' intervention compliance. Reference MRMI Gain was a clinical prediction model based on big data concept to support goal-orientated approach of physiotherapists in stroke rehabilitation. Stroke treatment library, a standardized exercise prescription in video format was also developed to facilitate standardized prescription of interventions to patients with different level of ability.

Eligibility Criteria:
Inclusion Criteria:

Patients with principal diagnosis of cerebrovascular accident, stroke, or hemiplegia and had received has received physiotherapy gym session training in a hospital in Hong Kong between the periods from 1 October 2018 to 31 September 2019 and from 1 October 2020 to 31 September 2021.

Exclusion Criteria:

Transfer out of the hospital, discharged against medical advice or died.