cyrilzakka/clinical-trials huggingface dataset:
Trial of Hydrocortisone for Post-Traumatic Stress Disorder (PTSD)

Developing novel and effective pharmacologic interventions for this post-traumatic stress disorder is important. The investigators propose to replicate findings of an earlier published pilot study using low dose hydrocortisone as a treatment for PTSD. In order to do so in a more meaningful way, the investigators will conduct a larger but similar randomized double-blind placebo-controlled, cross-over design treatment study examining the use of low dose hydrocortisone (or placebo) for 4 weeks in combat veterans suffering from PTSD.

The investigators hypothesize that, as described by Aerni et al. (2004), administration of daily hydrocortisone will lead to a reduction in PTSD symptom severity, but particularly for re-experiencing types (e.g., flashbacks, nightmares)of symptoms. The investigators also hope to examine potential predictors and moderators of treatment response based on subjects' clinical characteristics, as well as serum cortisol and ACTH levels.


Eligibility Criteria:
Inclusion Criteria:

* Male military veterans
* Between the ages of 18-65 years old
* Generally good medical health with no clinically significant abnormalities on physical examination, electrocardiogram, or laboratory findings
* Ability to provide informed consent and comply with requirements of study protocol
* No specific contraindications to hydrocortisone
* Clinically predominant DSM-IV diagnosis of PTSD
* Score of ≥ 40 on Clinician Administered PTSD Scale \[CAPS\]

Exclusion Criteria:

* History of moderate to severe traumatic brain injury, seizure or organic mental illness
* Lifetime history of schizophrenia, bipolar disorder, other psychotic disorder, or depression with a score of ≥ 16 on the 17-item Hamilton Depression Rating Scale (Hamilton, 1960), active suicidal ideation
* Unstable medical illness
* Subjects undergoing any formal psychotherapy within 3 months of enrollment
* Subjects that meet criteria for substance dependence during the last 6 months
* History of adverse reaction to corticosteroids.
* Concurrent use of other psychotropic medication (e.g. benzodiazepines, antipsychotics)
Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula

Up to date, a sure cure for Crohn's fistula has not known and the fistula recurrence rate is high. On 15 October 2008, orphan drug designation was granted by Korea FDA to Anterogen Co. Ltd., for human adipose-derived stem cell. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to test the safety and efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Prior diagnosis of Crohn's disease
* patients who have Crohn's fistula
* negative for urine beta-HCG for woman of childbearing age
* agreement to participate, with signed informed-consent

Exclusion Criteria:

* patients who have allergy to bovine-derived materials or an anesthetic
* patients with a diagnosis of auto immune disease except for Crohn's disease
* Diagnosis of HBV, HCV, HIV and other infectious disease
* Patients who have a symptom of septicemia
* Patients with a diagnosis of active Tuberculosis
* Patients who are pregnant or breast-feeding
* Patients who are unwilling to use an "effective" method of contraception during the study
* Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease
* Patients who is sensitive to Fibrin glue
* Patients who have a clinically relevant history of abuse of alcohol or drugs
* Insufficient adipose tissue for manufacturing of ADIPOPLUS
* Patients who are considered not suitable for the study by investigator
* Patients who have history of surgery for malignant cancer in the past 5 years
DCD IIT: Evaluating the Safety of Utilizing Donor Hearts From Donation After Circulatory Death (DCD) Donors

The purpose the research is to evaluate whether patients who receive a Donation after Circulatory Death (DCD) heart for cardiac transplantation using either normothermic regional perfusion (NRP) or direct procurement and perfusion (DPP) have similar outcomes as patients who receive Donation after Brain Death (DBD) heart using standard cold storage. The study will also evaluate whether DCD procured hearts have a meaningful impact on hearts available for transplantation at our center.

In the U.S., heart donation occurs after a person has been declared brain dead and is called a donor after brain death (DBD). In these patients, the heart continues to beat and pump blood throughout the body. After life support is withdrawn, organs are retrieved immediately for transplantation. This study will use hearts from donors after circulatory death (DCD) donors. DCD donors are those whose hearts have stopped beating and no longer pump blood. DCD hearts are not used as often for transplantation today in the U.S. because they may be further injured during traditional cold storage. In the US, donor hearts are currently mostly obtained from donors after brain death (DBD), although DCD donors are used for other donated organs, such as: lungs, kidneys, and livers.

This study will evaluate whether patients who receive a DCD heart transplant using either NRP or DPP have similar outcomes as patients who receive DBD hearts using standard cold storage. The study will also evaluate whether DCD procured hearts have a meaningful impact on hearts available for transplantation at our center. Ten (10) DCD donor heart recipients will be enrolled into the study intervention group, and approximately 30 DBD donor heart recipients will be enrolled into the control group.

Eligibility Criteria:
Recipient Inclusion Criteria:

1. Subjects must be willing and be capable of understanding the purpose and risks of the study and must sign a statement of informed consent OR consent of a legally authorized representative of a cognitively impaired individual will be obtained before the cognitively impaired individual may be included in research.
2. Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
3. Male or female, aged 18 years of age or older listed for primary heart transplant

Recipient Exclusion Criteria:

1. Prior history of cardiac transplantation
2. Multi-organ transplant
3. Current or planned participation in another interventional trial
4. Recipient has any condition that, in the opinion of the Investigator, would make study participation unsafe or would interfere with the objectives of the study
Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes

The study is conducted in Europe. The aim of this observational study is to assess glycaemic control while using liraglutide under normal clinical practice conditions in Belgium.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Insufficiently controlled after 3 months of treatment with OADs (oral anti-diabetic drugs)

Exclusion Criteria:

* Previously treated with liraglutide
* Hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
* Pregnant, breast feeding or have the intention of becoming pregnant
MMEPT for Traumatic Brain Injury

The primary purpose of this research is to increase adherence to outpatient rehabilitation of chronically underserved individuals with traumatic brain injury (TBI). The intervention will be a TBI rehabilitation-focused education tool suitable for use with a wide variety of patients, including those with poor literacy skills and those with Limited English Proficiency (LEP), hereafter referred to as the Multimedia Multicultural Educational Program for TBI (MMEPT).


Eligibility Criteria:
Inclusion Criteria:

* A medically documented (e.g., EMS report, hospital record, physician record) TBI as a result of a blow to the head requiring admission to an acute inpatient rehabilitation unit, meeting at least one of the following criteria for moderate to severe TBI:

  1. PTA \> 24 hours
  2. Trauma related intracranial neuroimaging abnormalities
  3. Loss of consciousness exceeding 30 minutes
  4. GCS in emergency department of less than 13 (unless due to intubation, sedation or intoxication)
* Proficient in Chinese (Mandarin or Cantonese), Spanish or English,
* Willing to engage in the MMEPT and complete questionnaires,
* Agreeing to participate (i.e., completion of informed consent and HIPAA documents).

Exclusion Criteria:

* Preferred language (language with greatest proficiency) other than English, Chinese or Spanish,
* In minimally conscious or vegetative state,
* Significant symptoms of receptive aphasia, and
* Any acute medical condition that, in the investigator's opinion, makes the person unsuitable or unable to participate. Participants enrolled in the study who are ultimately not discharged to the community at the completion of acute inpatient rehabilitation will be removed from the study.
Yoga in Improving Quality of Life in Patients With Non-small Cell Lung Cancer Undergoing Treatment

The purpose of this research study is to evaluate the effects of yoga (including breathing exercises) on the quality of life in patients, diagnosed and undergoing standard treatments for non-small cell lung cancer.

This clinical trial studies yoga in improving quality of life in patients with non-small cell lung cancer undergoing treatment. Yoga may help improve quality of life and pulmonary functional capacity in patients with non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients with any type of non-small cell lung cancer who are undergoing medical treatment, including surgery, radiation and / or chemotherapy.

Exclusion Criteria:

* Metastasis to the brain, problems during surgery leading to myocardial infarction or hemorrhage, cerebral infarction or hemorrhage, respiratory failure, non-healing surgical wound.
Neoadjuvant Nab-Paclitaxel and S-1 in Borderline Resectable Pancreatic Cancer

This study was a single-arm multicenter prospective phase II clinical study, designed to evaluate the efficacy and safety of neoadjuvant nab-paclitaxel combined with S-1 in patients with borderline resectable pancreatic cancer. A total of 60 subjects who meet the criteria will receive neoadjuvant chemotherapy of nab-paclitaxel and S-1, for a maximum of 4 cycles prior to pancreatectomy. The primary endpoint is R0 resection rate, the secondary endpoints include overall survival and response rate.


Eligibility Criteria:
Inclusion Criteria:

1. Patients have good compliance, can understand the research process of this study, and sign a written informed consent
2. Patients with pathologically confirmed pancreatic adenocarcinoma.
3. Patients who have not received prior chemotherapy, radiotherapy or other systematic treatment for pancreatic cancer;
4. Patients with borderline resectable pancreatic cancer ( NCCN Version 1，2019 criteria).
5. ECOG PS 0-1;
6. Tumor size is measurable according to RECIST1.1 criteria
7. Expected survival over 3 months;
8. Bone marrow function: neutrophils≥1.5x109/L, platelets ≥100x109/L, hemoglobin≥ 90g/L;
9. Liver and kidney function: serum creatinine≤1.5ULT; AST and ALT≤ 2.5 ULT; total bilirubin ≤ 1.5 ULT;
10. No contraindications to the use of S-1 and nab-paclitaxel.

Exclusion Criteria:

1. ≥ Grade 2 existing peripheral neuropathy;
2. Any other malignancy within 5 years prior to enrollment, with the exception of adequately treated in-situ carcinoma of the cervix, uteri, bladder, or nonmelanomatous skin cancer.
3. Active, uncontrolled infection(s) requiring systemic therapy, defined as ongoing signs/symptoms related to the infection without improvement despite appropriate treatment.
4. Severe, active co-morbidity, defined as follows:

   Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months Transmural myocardial infarction within the 6 months of study registration Uncontrolled hypertension, diabetes or arrhythmia. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization.
5. Not able to take medicine orally.
6. Pregnancy or lactation, and women of childbearing age who refused to take appropriate contraceptive measures during the course of this study;
7. Participation in other clinical trial within 30 days before the first dose of the drug;
Acute Appendicitis: The Influence of C-reactive Protein and Leucocytes on Clinical Decision-making

Aim: To investigate if the results of CRP and leucocytes had any positive or negative influence on the surgeon's decision-making when handling patients with suspected AA.

A prospective observational cohort study including patients (≥15 years of age) admitted on suspicion of AA. The surgeons were instructed to perform their physical examination and register whether they found the patient more or less than 50% likely to have AA. Thereafter, the surgeons had to assess the blood results and reevaluate their diagnosis. The surgeon's diagnosis before and after was compared to the final diagnosis defined by surgical findings or follow up. Gold standard was any degree of appendicitis on histology.

Eligibility Criteria:
Acutae abdominal pain Suspect for acute appendicites
Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)

A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specific genital disease among Chinese females between the ages of 20 and 45.

The Base Study V501-041 duration was 30 months. The study was extended to further evaluate the efficacy of Quadrivalent HPV (Type 6, 11, 16, 18) L1 VLP (qHPV) vaccine against Cervical Intraepithelial Neoplasia Grade 2 (CIN 2), CIN 3, Adenocarcinoma In Situ (AIS), and/or cervical cancer. The efficacy was followed through the Month 78 visit, and the close-out visit was conducted at approximately Month 90 with only safety data collected

Eligibility Criteria:
Inclusion Criteria:

* Healthy women between the ages of 20 and 45
* Have used effective contraception for 2 weeks prior to starting in the study
* Does not have a temperature within 24 hours before the first injection

Exclusion Criteria:

* Prior history of genital warts
* More than 4 lifetime sexual partners
* Have undergone hysterectomy
* Have active cervical disease or history of cervical disease
The Effects of Exercise on Behavior and Fitness in Children With ASD

This study will examine the effects of a school based exercise intervention programme on the behaviour and fitness levels in children with autism.

This study will examine the effects of a school based exercise intervention programme on the behaviour and fitness levels in children with autism. Local primary schools who have an Autism Spectrum Disorder (ASD) class will be approached to participate in the project. The age profile of the children will be 4-12 years of age and they will have mild-sever levels of autism. The exercise intervention programme will be delivered 3 times per week in the schools over an 8 week period.

Children will be fitness tested to assess the change in fitness levels over the 8 week period. Questionnaires will be given to the parents and teachers of the children at the beginning and at the end of the programme to assess changes in behaviour levels as a result of the exercise intervention programme.

Eligibility Criteria:
Inclusion Criteria:

• Diagnosis of Autism Spectrum Disorder

Exclusion Criteria:

• Any medical condition which excludes the child from partaking in exercise
PROMIS Evaluation Study

A total of 250 total hip arthroplasties (THA) are performed at the Bezirkskrankenhaus St. Johann. In a majority of those, implants from the company Falcon Medical (Austria) are used. Those implants are undergoing constant development and improvement. To guarantee their clinical performance, this clinical study is evaluating safety and efficacy of all implants produced by Falcon Medical.

The purpose of this study is to evaluate the effcacy and safety of implants produced and distributed by Falcon Medical. All patients with primary THA and usage of a Falcon Medical implant are included. The outcome measures include intra-operative complications, early post-operative complications, revision for any cause and patient reported outcome (WOMAC questionnaire). All data is prospectively collected in a standardized fashion.


Eligibility Criteria:
Inclusion Criteria:

* Primary total hip arthroplasty with the PROMIS stem

Exclusion Criteria:

* n/a
Development and Evaluation of SM-ART Intervention (SM-ART)

The approach of this intended research is to help pregnant women practice constructive coping and proactive skills that focus on positive adaptation for safe motherhood through our developed intervention.

The objective of this two phases Randomized Control Trial is to develop contextually based "SM-ART" intervention \[Safe Motherhood ART: Accessible Resilience Training\] and evaluate the effectiveness of "SM-ART" intervention in a sample of pregnant women living in low socioeconomic urban areas of Karachi, Pakistan.

It is hypothesized that the SM-ART intervention will enhance resilience and marital harmony and decrease symptoms of depression, anxiety in pregnant women.

The prevalence of perinatal depression and anxiety in South Asia are among the highest in the world. In Pakistan, approximately 18% to 60% of women experienced depressive symptoms at some point during their pregnancy. Early intervention for the management of mental illness in pregnancy is imperative as the effects of perinatal mental ill-health is not only limited to mothers but also can negatively impact child health outcomes. In a public health context, positive psychological interventions should be promoted as it reduces the burden of treatment, and enhance cost effective approaches in resource poor countries such as Pakistan.

As in Pakistan, no program has been planned and tested to enhance the positive psychological wellbeing among pregnant women that is based on individual strengths, that can be learnt, sustained and low cost as well. Hence, this study aims to facilitate pregnant women in practicing constructive coping and proactive skills which will help them to focus more on the positive approach of life rather than looking for the negative situations that is carried out in their daily lives.

The study will carried out in two phases:

Phase I: The objective of phase one is study is to develop "SM-ART" intervention \[Safe Motherhood ART: Accessible Resilience Training\]

Phase II: The objective of phase two is to test the effectiveness of "SM-ART" intervention \[Safe Motherhood ART: Accessible Resilience Training\] to improve resilience, marital harmony and decrease depression and pregnancy related anxiety in a sample of pregnant women presenting to Koohi Goth Hospital of Karachi, Pakistan

Eligibility Criteria:
Inclusion Criteria:

1. All participants should provide written consent, be 18+ years of age
2. All participants should be currently married at a gestational age of 12 to 30 weeks: by 12th week, pregnancy is confirmed, they do visit health clinic and upper bar is set to 30 weeks so there should be adequate time to provide the intervention and observe the effectiveness.
3. Participants should speak and understand urdu, as all our assessments and intervention will be in local language.

Exclusion Criteria:

Participants with a history of mental illness and/or physical illness will be excluded as will those taking antianxiety, antidepressant, anti psychotic medication.
Sutureless Versus Conventional Thyroidectomy

This study was prospective randomized double-blinded clinical trial on patients with thyroid disease who underwent thyroidectomy in the general surgery department, Mansoura university hospitals during the period of February 2017 to February 2018.Two techniques for vascular sealing were compared: conventional tying and harmonic scalpel


Eligibility Criteria:
Inclusion Criteria:

Patients of both genders aging above 18 years presented with primary thyroid diseases requiring thyroidectomy including:

* Solitary thyroid nodule (STN)
* Multinodular goiter
* Controlled toxic goiter
* Inflammatory goiter (thyroiditis)
* Early-stage thyroid cancer.

Exclusion Criteria:

* Patients unfit for surgery
* patients unwilling to participate in the study
* Pregnant women
* Thyroid cancer with lymph node or distant metastasis.
* Patients with psychiatric disturbances.
Incidence of Trauma Induced Coagulopathy in Patients With Prehospital Administration of Fibrinogen

The purpose of the study is to find out the incidence of trauma induced coagulopathy in patients with severe trauma who received fibrinogen prior admission to emergency department during prehospital care.

The study will commence following the Approval by The Ethics Research Committee. All patients admitted to emergency department from the 1st of July 2018 to the 30st of June 2020 will be enrolled after fulfilling the inclusion criteria and in the absence of any exclusion criteria. Informed consent will be requested. After admission to emergency department the blood samples will be taken and blood tests and viscoelastic tests will be performed. All data and results will be entered in the study form. Statistical analysis will be performed and incidence of trauma induced coagulopathy estimated. 28-day mortality will be also monitored.

Eligibility Criteria:
Inclusion Criteria:

* multiple trauma, injury severity score (ISS) ≥16
* administration of fibrinogen in prehospital care
* age 18-80 years

Exclusion Criteria:

* ISS 75
* pregnancy
* therapeutic anticoagulation
* therapeutic antiaggregation
Study of Acamprosate in Fragile x Syndrome

In this research study we want to understand the effectiveness of a drug treatment, acamprosate, for interfering symptoms (i.e., inattention/hyperactivity, social impairment) associated with Fragile X Syndrome (FXS).

Each subject with FXS will receive 10 weeks of blinded treatment with acamprosate or matching placebo. After completion of the double-blind phase, all subjects will have an opportunity to receive acamprosate as part of the study procedures for 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnostic confirmation of full mutation FXS
* Age ≥5 years and \<23 years
* General good health as determined by physical exam, medical history and laboratory work up.

Exclusion Criteria:

* Use of more than two psychotropic medications (medications affecting behavior).
* Unstable dosing of any psychotropic medication (medication affecting behavior)
* Problems with kidney functioning
* Unstable seizure disorder
* Change in any anti-convulsant drug dosing in the 60 days prior to study entry
* Prior adequate treatment trial with acamprosate as determined by the study doctor
* Pregnant or lactating females