cyrilzakka/clinical-trials huggingface dataset:
Assessment of Bone Mineral Density During Pregnancy

BMD at peripheral sites typically heel is measured by Ultrasound densitometry at Ain Shams Maternity hospital.

Consecutive patients with singleton pregnancies between 36 and 39 weeks booked at a general obstetric clinic in a regional hospital will be recruited for the study. The obstetric department is a tertiary referral center in the region and part of a university teaching unit which catered to an annual delivery of around 10,000 women. A group of first trimester pregnant women with nearly the same age is recruited as controls.

Eligibility Criteria:
Inclusion Criteria:

1. females during 3rd trimister

Exclusion Criteria:

1. Secondary causes of bone loss such as hyperparathyroidism.
2. Co-morbidities that would interfere with bone metabolism as clinically significant liver or renal disease.
3. Physical or orthopedic disabilities that would place the subject at risk or limit their ability to perform US.
4. Taking medication known to affect bone including steroid hormones.

Histories of smoking and use of oral contraceptives (OCs) are not exclusion criteria.
Effect of Brief Dietary Intervention on Ammonia Levels

Study the impact of differing meal contents on venous ammonia levels over time in patients with cirrhosis. Patients will be given specific meals and venous ammonia analyzed over time after those meals.

The subjects will also provide stool for microbiome and serum, urine and plasma for metabolomics during this one-time study.

Total duration=4 hours

Patient will be instructed to collect stool for baseline assessments. After a fast (\>4h from last meal) a venous blood sample will be drawn for analysis of baseline laboratory tests and spot venous ammonia and blood and urine for metabolomics and blood microbiome. Spot ammonia and blood for metabolomics and microbiome will be collected from repeat samples at 1h and 2 hrs after a standardized meals from the three groups of protein meals. Urine will also be collected for metabolomics during the observation period. On the day of the study, patients will be asked to complete a standard food frequency questionnaire encompassing meals over 3 days prior to the study.

Subjects will be randomly assigned into 3 groups (meal types A, B and C) with the standardized meal that contains 20gm of protein. All subjects are expected to consume it in its entirety. Subjects are not allowed to eat anything else until the end of the study.

Subjects will be observed in the unit for a total of 3 hours after the standardized meal to ensure no symptoms related to potential elevated ammonia emerge. Any adverse events will be treated according to standard clinical routine.

Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis
2. Able and willing to voluntarily complete the informed consent process
3. Available for and agree to all study procedures
4. Consistent non-vegetarian Western dietary patterns for at least a month prior to the study assessed by dietary interview

Exclusion Criteria:

1. MELD score \> 23
2. Unclear diagnosis of cirrhosis
3. History of liver transplant
4. Body mass index \< 18.5 or ≥ 40 kg/m2
5. Prior transjugular intrahepatic portosystemic shunt placement
6. Treatment with systemic (e.g., oral or intravenous) antibiotic (apart from rifaximin) within 4 weeks prior to enrollment
7. For those with HE: stable dose of medications (lactulose or rifaximin) without a recent (\<1 month episode of HE)
8. Current use of valproate, corticosteroids, or cytotoxic drugs.
9. Apart from chronic liver disease, any acute or chronic medical, surgical, psychiatric, or social condition including history of cerebrovascular disease (stroke, transient ischemic attack) or dementia, that may increase the subject risk associated with study participation, compromise adherence to study procedures and requirements, confound interpretation of the results, and, in the judgment of the investigator, make the subject inappropriate for enrollment.
Clinical Trial of Interpersonal Therapy for Survivors of the Sichuan Earthquake

The enormous global burden of mental illness has been estimated through the publication of the Global Burden of Disease Study. Research confirms that populations exposed to mass trauma such as natural disaster bear a particularly high burden of mental disorders, with depression and Posttraumatic Stress Disorder (PTSD) generally being the top two adult psychiatric diagnoses. In traumatized populations, these disorders do not remit with replacement of material losses or resettlement to safe locations, but rather tend to become chronic conditions with attendant disability. PTSD and depression are risk factors for anger, interpersonal discord and violence, not only among those who have trauma and depression, but also among their spouses and children. This "infectious" model of trauma/violence is critically important in the setting of natural disaster, as increased levels of interpersonal violence within the afflicted community hinder its recovery. To date, there has been little research on the interpersonal effects of mass trauma. The proposed research is a randomized controlled trial of "Interpersonal Therapy" (IPT) versus wait list control (WLC) for survivors of the Sichuan Earthquake living in Shifang, China. IPT, a very effective therapy for depression, has been adapted for PTSD treatment and developing country settings. Measures will evaluate success of the treatment not only in terms of individual depression and PTSD symptoms, but also with respect to interpersonal functioning.

Hypothesis 1: Relative to wait list control, fewer subjects who received IPT will meet criteria for Depression and PTSD at the conclusion of the RCT.

Hypothesis 2: Subjects who received IPT will have greater improvement of social functioning than wait list controls.

Interpersonal Psychotherapy adapted for local mental health care needs was applied using wait list control design.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years;
* diagnosis with Depressive Disorder and Posttraumatic Stress Disorder (PTSD);
* Ability to attend weekly therapy sessions for 12 weeks and return for post-treatment screening;
* Ability to give verbal informed consent

Exclusion Criteria:

* Cognitive dysfunction which requires a higher level of care and/or interferes with ability to participate in IPT;
* Severe thought or mood disorder symptoms which requires a higher level of care and/or interferes with ability to participate in IPT;
* drug and alcohol dependence
Correcting Platelet Dysfunction After Traumatic Brain Injury

This study evaluates the impact of platelet transfusion on geriatric patients with platelet dysfunction from Traumatic Brain Injury. The authors hypothesize that patients will recover better if their platelet dysfunction is corrected with platelet transfusion.

The geriatric population is subject to traumatic brain injury, often occurring as a result of falls. This patient population is also often receiving anticoagulants and platelet inhibitors increasing their risk of post-injury hemorrhage. Following Traumatic Brain Injury, even without platelet inhibitor medications, platelets become dysfunctional and are no longer able to assist with clot formation. Therefore risk of hemorrhage is increased, both in the brain, and other hemorrhagic sites. Clinical practice at Carolinas Medical Center is to transfuse platelets in patients with platelet dysfunction following brain injury. The current study is investigating the impact of transfusion on correction of platelet dysfunction and patient outcome.

Furthermore, stored platelet dysfunction can be corrected by supplementation with cytochrome c, which supports mitochondrial function. Therefore, the ability of cytochrome c to correct dysfunction in ex vivo platelets from patients with Traumatic Brain Injury will be assessed.

Eligibility Criteria:
Inclusion Criteria:

Traumatic brain injury with Glasgow Coma Scale Score (GCS) \<=13

Exclusion Criteria:

Previously know coagulation dysfunction
Assessment of Knowledge and Attitude Toward Obstructive Sleep Apnea in Medical Teams

Obstructive sleep apnea (OSA) is a serious and often underreported condition, despite its highly prevalent distribution. Medical teams play an integral role in screening and managing patients with a high risk of developing OSA.


Eligibility Criteria:
Inclusion Criteria:

Medical teams including:

* Students of medical schools and dentistry
* General practitioners
* Dentists
* Medical specialists
* Highly trained nurses (HIN)

Exclusion Criteria:

* Non- medical personnel's
In Turkish Version "Health Care Providers and Impairment Relationship Scale (HC-PAIRS)"

The aim of this study was to determine the Turkish validity and reliability of ''Health Care Providers and Impairment Relationship Scale HC (HC-PAIRS)'' developed by Dr Rainville.

Low back pain is one of the reasons for applying to health institutions. Low back pain, which seriously affects patients' lives and leads to major financial losses, causes serious deficiencies in both developing and developed countries. Health professionals' perception of pain, factors associated with pain and fear avoidance attitudes of patients affect the success of treatment. The aim of this study is to determine the Turkish version, validity and reliability of ''Health Care Providers and Impairment Relationship Scale (HC-PAIRS)''. 165 physiotherapist working with chronic low back pain were included in the study. In order to determine the reliability of the scale, the intraclass correlation coefficient (ICC) will be used to determine the level of the relationship between the results of the first and second measurements. Cronbach's alpha coefficient will be used for homogeneity of the questions in the scale. For concurrent validity, correlation coefficient will be used to determine the agreement between the previously validated scales and the Turkish version of HC PAIRS.

Eligibility Criteria:
Inclusion Criteria:

* Graduate with a bachelor's degree in physiotherapy and rehabilitation
* To have worked in patients with chronic low back pain

Exclusion Criteria:

* Not having experience in the clinic about low back pain
Study in Stabilized Schizophrenic Patients to Evaluate the Pharmacokinetics of Risperidone and 9-Hydroxy (OH)-Risperidone When Risperidone is Administered From a Polyurethane Implant

The study will be a 6-month, open-label, multiple center study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants.

The study will be a 6-month, open-label, study in approximately 50 stable subjects diagnosed with schizophrenia or schizoaffective disorder to evaluate the safety, tolerability, and pharmacokinetics of Risperidone and 9-OH-Risperidone following implantation of two or three, 300 mg Risperidone Implants.

Subjects who are diagnosed with schizophrenia or schizoaffective disorder according to DSM-V and are stable on a daily 4 mg oral dose of Risperidone for at least 8 weeks will be recruited into the study.

Subjects stable on a 4 mg oral dose of Risperidone will be implanted with two or three, 300 mg, Risperidone Implants. All implants will be placed in the inner aspect of the upper arm. Plasma concentrations of Risperidone and the active moiety will be measured prior to placement of the Risperidone Implants, throughout the implantation period, and after re-converting to oral Risperidone following the removal of the Risperidone Implants.

Eligibility Criteria:
Inclusion Criteria:

1. Subject (and/or a subject's authorized legal representative) has provided written informed consent
2. Patient meets the following criteria:

   * Outpatient status
   * PANSS Total Score ≤ 80 at screening and if PANSS score at baseline is ≥ 20% change from screening, the patients cannot participate in the study.
   * A score of ≤ 3 on the following PANSS items:

     * Conceptual disorganization
     * Suspiciousness
     * Hallucinatory behavior
     * Unusual thought content
3. Subject is male or female between 18 to 60 years of age
4. Subject has a diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) criteria

Exclusion Criteria:

1. Hospitalized or required acute crisis intervention for symptom exacerbation in the 60 days prior to admission as determined by the Investigator
2. Subject has a history of suicide attempt in the last year, or in the opinion of the investigator is currently at imminent risk of suicide
3. Has a current or recent (within 12 months) DSM-V diagnosis of moderate or severe substance use disorder (except for tobacco use disorder) or has a positive urine drug screen for prohibited substances at screening.
4. Have impaired hepatic (ALT/AST \>1.5 times higher than the upper limit of normal) or renal function (eGFR\<50 mL/min)
5. Previously defined hypersensitivity to Risperidone
6. History of neuromalignant syndrome (NMS)
7. Electroconvulsive therapy within 6 months of admission
8. Requires current use of agents that are strong inhibitors and inducers of cytochrome P450 2D6
Live Birth Rate Between PPOS and GnRH Antagonist Protocol in Patients With Anticipated High Ovarian Response

Progestin can inhibit the pituitary LH surge during ovarian stimulation and various studies show progestin-primed ovarian stimulation (PPOS) is effective in blocking the LH surge in IVF. More and more centers in China are using PPOS because this regimen appears simpler and cheaper.A randomized trial to compare the effectiveness of PPOS and GnRH antagonist protocol in IVF in terms of the live birth rate is urgently needed.

Trial objectives: To compare the live birth rate between the PPOS protocol and the antagonist protocol used for ovarian stimulation during IVF

Eligible women will be randomised into one of the two groups:

Antagonist group : Women will receive antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.

PPOS group: Women will receive oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger.

There will be no fresh transfer. Only one blastocyst will be allowed to replaced in the first FET and a maximum of two blastocysts will be replaced in the subsequent FET cycles.

The primary outcome is the live birth rate of the first frozen-thawed transfer cycle.


Eligibility Criteria:
Inclusion Criteria:

* Age of women \<43 years at the time of ovarian stimulation for IVF
* The first IVF cycle
* Antral follicle count (AFC) \>15 on day 2-5 of the period

Exclusion Criteria:

* Presence of a functional ovarian cyst with E2\>100 pg/mL
* Recipient of oocyte donation
* Undergoing preimplantation genetic testing
* Presence of hydrosalpinx or endometrial polyp which is not surgically treated
Safety of Imovax Polio in Chinese Infants and Children

To describe the tolerance in terms of occurrence of serious adverse reactions and severe adverse reactions (injection site and systemic) within eight days after one dose of IMOVAX Polio™ administered in children and infants.


Eligibility Criteria:
Inclusion Criteria:

* Group 1: Aged 18 months (18-20 months) on the day of inclusion
* Group 2: Aged 2 months (56-70 days) on the day of inclusion

Exclusion Criteria:

* Participation in another clinical trial in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
* Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion
* Blood or blood-derived products received in the past 3 months (for Group 1) or since birth (for Group 2)
* Any vaccination in the 4 weeks preceding the trial vaccination (except BCG and Hepatitis B \[Hep B\] for Group 2)
* Vaccination planned in the 4 weeks following the trial vaccination
* Group 1: Previous booster vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
* Group 2: Previous vaccination against the poliomyelitis infection with the trial vaccine or with another vaccine.
* History of poliomyelitis infection (confirmed either clinically, serologically or microbiologically)
* Clinical or serological evidence of systemic illness including Hepatitis B, C and HIV
* Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
* History of/current seizures
* Febrile illness (axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion
Development of a Non-invasive Prenatal Test

This is an observational study to aid in the development of a non-invasive prenatal test that may be used to aid in detection of fetal aneuploidy. Pregnant women will be recruited and asked to provide a blood sample to be used for general test development purposes.

Blood samples and information collected for the study will be used for test development and quality control purposes. No test results will be communicated back to study subjects or their health care providers.

Eligibility Criteria:
Inclusion Criteria:

* Subject has singleton or twin pregnancy confirmed via evaluation by a healthcare provider
* Subject is able to provide informed consent
* Subject is ≥ 18 years of age
* Subject is at least 10 weeks gestation for general enrollment
* Subject has no known risk factors for chromosomal abnormalities of the fetus
* Subject has no suspected or confirmed fetal abnormalities

Exclusion Criteria:

* Subject is pregnant with more than two fetuses
* Subject is unwilling to undergo a blood draw
Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)

The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.

Irritable Bowel Syndrome (IBS) is a functional disorder characterised by chronic or recurrent abdominal pain or discomfort associated with altered bowel habits. This trial aims to evaluate the efficacy of Ibodutant in improvement of IBS symptoms through a daily oral administration, testing three dosages or placebo in IBS patients for 4-weeks. In each patient, the experimental clinical phase encompasses a screening/ 2-week run-in period (no study medication), followed by a 4-weeks treatment period and a 2-weeks treatment withdrawal period, for total study duration of 8 weeks in each patient.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 18 - 70 years.
2. Clinical diagnosis of IBS .
3. For patients older than 50 years or patients with positive family history of colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy.
4. Use of appropriate contraceptive methods.
5. Normal physical examination or without clinically relevant abnormalities.

Exclusion Criteria:

1. Patients with organic abnormalities of the gastro-intestinal tract including history of colonic or major abdominal surgery, current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
2. History of gluten enteropathy.
3. Lactose intolerance as assessed by response to diet
4. Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
5. Previous diagnosis of Diabetes Mellitus (either type 1 or 2)
6. Unstable medical condition.
7. Concomitant medication within 7 days prior to screening with drugs known to interfere with gastro-intestinal motility and sensitivity.
8. Pregnancy or breastfeeding.
9. Patient not able to understand or collaborate throughout the study.
10. Participation in other clinical trials in the previous 4 weeks.
Internal Limiting Membrane Peeling-reposition to Treat Idiopathic Macular Holes

To compare the morphologic and functional outcomes of internal limiting membrane peeling-reposition versus peeling in idiopathic macular holes

This randomized clinical trial will be performed at a single center. Eligible patients with idiopathic macular holes will be equally randomized to internal limiting membrane (ILM) peeling-reposition group or ILM peeling group through computer-aided random allocation.

A standard 3-port pars plana vitrectomy was performed by a single surgeon using the Constellation 23 gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, Texas, USA).After posterior vitreous detachment was achieved, peeling of the ILM was performed by an end gripping forceps with the assistance of Brilliant Blue G. In ILM peeling-reposition group, the peeled ILM flap is flatten back to peeled area with assistance of perfluoro-n-octane. In ILM peeling group, a round shape with 2.5 to 3.5 disc diameter of ILM is peeled. This is followed by a complete fluid-gas exchange. Patients are encouraged to maintain a face-down position for two weeks postoperatively in two groups.

Postoperative measurements of BCVA and spectral domain optical coherence tomography(SD-OCT) are conducted at 1,3 and 6-month follow-up visits by independent masked observers. Macular light sensitivity and fixation stability are determined with microperimetry at 1,3, and 6 months of follow-up. Mf-ERG, M-score chart and VFQ-25 chart are performed 1,3, and 6 months of follow-up.

Comparison of BCVA, anatomical closure were primarily performed between the two groups. Then, the morphologic changes of inner retina and the functional parameters measured from microperimetry, Mf-ERG, M-score chart, VFQ-25 chart were analyzed.

Eligibility Criteria:
Inclusion Criteria:

* The patients are diagnosed as macular hole by optical coherence tomography.
* Age ranges from 50 to 80 years.
* The patients have indication for surgery.

Exclusion Criteria:

* Traumatic macular hole.
* Combined with serious epiretinal membrane.
* Combined with diabetic retinopathy, hypertensive retinopathy.
* Combined with other ocular diseases, such as keratitis，uveitis，retinal vasculitis.
* - 6.0 diopters or more of spherical equivalent, 26mm or more of axial length.
* History of intraocular surgery.
* Presence of staphyloma.
* Other ocular diseases that could influence macular microstructure or visual function

Exit criteria:

* For reposition group, the patients will exit the research if the peeled ILM cannot reposition successfully.
* Due to adverse events, especially severe adverse events, the researchers consider withdrawal of patients based on concerns of safety and ethics;
* Drop out;
* The patients voluntarily withdraw the informed consent;
* Serious violation of the study protocol due to the subjects or investigators' reasons;
* Other reasons that the researchers believe for quitting the study.