cyrilzakka/clinical-trials huggingface dataset:
Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia

This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia


Eligibility Criteria:
Inclusion Criteria:

* Male and female individuals between 18 and 64 years, inclusive, at screening with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders: edition 5 (DSM-5)
* Body mass index (BMI) between 18 and 35 kg/m\^2 at screening
* Male and female subjects who are surgically sterile, female subjects who have been postmenopausal for at least 12 consecutive months prior to screening or male/female subjects who agree to remain abstinent or practice 2 of the approved birth control methods from screening for at least 150 days after dose of Investigational Medical Product (IMP) for female subjects or 180 days after dose of IMP for male subjects.
* Documented history of previously tolerating Aripiprazole per investigator's judgment.

Exclusion Criteria:

* Met DSM-5 criteria for substance use disorder within past 180 days
* Positive drug screen for drugs of abuse
* Use of more than 1 antipsychotic medication at screening or baseline, except for oral Aripiprazole administered during tolerability testing and current antipsychotic medication
* Subjects may not receive varenicline beyond the screening visit.
* Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to administration of IMP
* Major surgery within 30 days prior to administration of IMP or surgery during the trial
* Subjects at significant risk of committing suicide based on history, psychiatric exams
* Subjects currently in an acute relapse of schizophrenia
* Subjects with a current DSM-5 diagnosis other than schizophrenia
* Subjects with a history of neuroleptic malignant syndrome, seizure disorder, or clinically significant tardive dyskinesia
* Subjects who have had electroconvulsive therapy within 2 months prior to administration of IMP
* Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP
* History of or current hepatitis or Acquired Immunodeficiency Syndrome or carriers of Hepatitis B surface antigen (HBsAG), Hepatitis C antigen (anti-HCV) and/or Human Immunodeficiency Virus (HIV) antibodies
First Time Mothers and Anal Incontinence Six Years Postpartum

Previous studies show that incontinence is relatively common during pregnancy and after delivery. Experiencing incontinence during pregnancy or in the first year after delivery increases the risk of long term incontinence. There is scarce documentation of the long term prevalence of anal incontinence (AI) in Norway. This study aims to explore prevalence and risk factors for incontinence approximately six years after delivery among the 1718 who participated in two previous studies exploring the prevalence and predictors of anal incontinence in late pregnancy and during the first year after first delivery, and the effect of pelvic floor muscle exercises as treatment for anal incontinence after delivery. Increased awareness and knowledge about risk factors and long term prevalence of anal incontinence among health professionals as well as pregnant and parous women may give indications about which women to target for preventative measures to reduce the risk of new onset of postpartum AI during pregnancy and after delivery. Further, increased knowledge may aid in planning individualized follow-up during pregnancy and the first year as well as in the long term among women with existing AI symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Participants in previous studies

Exclusion Criteria:

* Women not participating in previous studies
ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma

The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.

The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.

Eligibility Criteria:
Key Inclusion Criteria:

* Diffuse cutaneous scleroderma (duration \> 5 years)
* Cochin Hand Function Scale ≥ 20 units
* Symptoms consistent with Raynaud's Phenomenon
* Ability to safely undergo liposuction

Key Exclusion Criteria:

* Active infection
* Contracture(s) of any finger
* Sympathectomy within 6 months of Screening Visit
* Rheumatoid Arthritis
Viscosity of Fibre Predicts Cholesterol-lowering in Healthy Individuals

To investigate the role of fibre viscosity (low, medium, high) in lowering cholesterol in healthy individuals


Eligibility Criteria:
Inclusion Criteria:

-healthy individuals

Exclusion Criteria:

* regular alcohol consumption
* regular smoking
Feasibility Study of Laparoendoscopic Single Site Surgical Staging for Endometrial Cancer

To compare the feasibility, safety, and efficacy between single-port and four-port laparoscopic surgical staging in patients with early stage endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated, histologically confirmed endometrial cancer
* Presumed FIGO stage 1
* Endometrioid adenocarcinoma
* patient who is planned to undergo surgical staging
* adequate oran function

  1. WBC \> 3000 cells/mcl
  2. Platelets \> 100000/mcl
  3. Creatinine \< 2.0 mg/dL
  4. Bilirubin \< 1.5 \* normal and SGOT or SGPT \< 3 \* normal
* American Society of Anesthesiologists Physical Status I-II
* Eastern Cooperative Oncology Group performance status 0-2
* Patients who have signed an approved Informed Consent

Exclusion Criteria:

* Uncontrolled medical disease
* Active infectious disease requiring antibiotics
* Previous pelvic radiation therapy
* Pregnant and lactating woman
* Patient who requires additional surgical procedures which are not necessary for surgical staging of endometrial cancer
Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease

This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.

After completing the study, patients were eligible to enroll in a long term safety study with continued access to vedolizumab (study C13008; NCT00790933) if study drug was well tolerated, and no major surgical intervention for Crohn's disease occurred or was required.

Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 80
* Diagnosis of moderately to severely active Crohn's disease
* Crohn's Disease involvement of the ileum and/or colon
* Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
* May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol

Exclusion Criteria

* Evidence of abdominal abscess at the initial screening visit
* Extensive colonic resection, subtotal or total colectomy
* History of \>3 small bowel resections or diagnosis of short bowel syndrome
* Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
* Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
* Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
* Active or latent tuberculosis
A Swedish Trial of Birth on a Birthing Seat

Background:

The World Health Organization (WHO) advises against recumbent or supine position for longer periods during labour and birth and states that caregivers should encourage and support the woman to take the position she finds most comfortable. It has been suggested that upright positions may improve childbirth outcomes and reduce the risk for instrumental delivery.

Objective:

The primary objective was to test the hypothesis that birthing on the "BirthRite" ® seat will result in a reduction in the number of primiparous women delivered instrumentally.

Method:

A power calculation showed (α = 0.05 β = 0.2) a requirement of 460 participants in each of the two arms of the trial in order to test for a 40% reduction (from 15% to 9%) of instrumental deliveries in primiparous women at a maternity unit in southern Sweden. It was decided to subject the study to a feasibility test by conducting a pilot-study in which 68 women were randomised to give birth on the birthing seat or to give birth in any other position but on the "BirthRite" ® seat. Randomization to birth on the birthing seat or in any other position took place when the participant's cervix was fully dilated. The primary outcome measurement was the number of instrumental deliveries. Secondary outcome measurements included oxytocin augmentation, perineal trauma, and blood loss administration of oxytocin for augmentation of labour, length of the second stage of labour, perineal trauma, perineal oedema, maternal blood loss and haemoglobin, apgar scores, cord pH and transfers to the Neonatal Intensive Care Unit(NICU).


Eligibility Criteria:
Inclusion Criteria:

* The pilot study included primiparous women who understood the Swedish language sufficiently well to receive information and give informed consent or refusal for participation.
* Pregnancy must have been normal, with a singleton fetus in cephalic presentation and the onset of labour occurring between gestation weeks 37 + 0 and 41 + 6.
* Women having diet treated pregnancy diabetes were also included.
* Obstetric primiparous women with former caesarean section were included as well as those induced because of premature rupture of membranes (PROM).

Exclusion Criteria:

* Multiparous women were excluded from the pilot study.
* Primiparous women were excluded in cases of birth before week 36 + 6, breech presentation, maternal BMI over 30, multiple pregnancy or infectious disease.
* Primiparous women with pre-eclampsia or other conditions that require medical care were not eligible for the pilot study.
Imaging Possible Appendicitis With CT

Pain in the right lower abdomen is one of the commonest reasons patients present to general surgeons as an emergency. Whether or not such patients have appendicitis is crucial to their assessment. In UK practice, when the diagnosis is unclear, ultrasound scanning (US) is commonly used to investigate the problem. US is very safe but it will only visualise the appendix in the minority of cases. As a result, the sensitivity for diagnosing appendicitis in this setting is probably only 5-30%. Alternatively, computed tomography (CT) is an accurate way of diagnosing appendicitis in over 90% of cases. CT scans are readily available and with modern scanners, high quality images can be achieved with lower radiation doses. Unenhanced scanning avoids the use of contrast media and permits further reductions in ionising radiation exposure.

Pain in the right lower abdomen is one of the commonest reasons patients present to general surgeons as an emergency. Whether or not such patients have appendicitis is crucial to their assessment. In UK practice, when the diagnosis is unclear, ultrasound scanning (US) is commonly used to investigate the problem. US is very safe but it will only visualise the appendix in the minority of cases. As a result, the sensitivity for diagnosing appendicitis in this setting is probably only 5-30%. Alternatively, computed tomography (CT) is an accurate way of diagnosing appendicitis in over 90% of cases. CT scans are readily available and with modern scanners, high quality images can be achieved with lower radiation doses. Unenhanced scanning avoids the use of contrast media and permits further reductions in ionising radiation exposure.

Eligibility Criteria:
Inclusion Criteria:

• Acute presentation with abdominal pain and/or tenderness which is most marked in the right lower abdomen

Exclusion Criteria:

* Age\<18
* Age\>60
* Pregnancy
* Patients with a firm clinical diagnosis of appendicitis where surgical management is indicated at presentation
* Patients who have undergone CT scanning within the past two months
* Patients with cognitive impairment who would lack capacity to give consent
* Inability to understand written or spoken English
* Patients who have previously undergone appendicectomy
Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Compared to Valsartan Monotherapy or Hydrochlorothiazide Monotherapy in Elderly (>70) With Mild-moderate Hypertension.

The purpose of the study is to evaluate the safety and efficacy of initial treatment therapy with valsartan/hydrochlorothiazide (HCTZ) versus the initial treatment therapy with monotherapies (valsartan or HCTZ) in the very elderly patients (greater than or equal to 70 years) with stage 1 or 2 hypertension


Eligibility Criteria:
Inclusion Criteria:

* Age 70 years or older.
* Patients with hypertension prior to being randomized into study.
* Patients must have an office cuff MSSBP ≥ 140 and ≤ 200 mmHg systolic.
* Have the ability to communicate and comply with all study requirements.
* Provide written informed consent to participate in the study prior to any screening or study procedures.

Exclusion Criteria:

* Use of other investigational drugs within 30 days of enrollment.
* History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
* Office blood pressure measured by office machine cuff with a mean of (3) MSDBP ≥ 120 mmHg at anytime during the screening / washout period.
* Patients taking 3 or more antihypertensive drugs and MSSBP ≥ 160 mmHg at the time of Visit 1.
* Other protocol-defined exclusion criteria may apply
Hemostatic Complications in Hematopoietic Stem Cell Transplantation

Hemostatic disorders are common and potentially fatal complications in patients undergoing hematopoietic stem-cell transplantation (HSCT). Limited data exist on early diagnosis and prevention of these complications. The investigators undertook this prospective study to determine the incidence, predictor factors, specific pathogenesis, management and survival specially for patients with thrombotic and bleeding complication to better improve outcomes.

Hematopoietic stem cell transplantation（HSCT）is a curative treatment for a variety of malignant and refractory benign hematologic disease, but is associated with life-threatening complications in the same time, among them, hemostatic disorders are not uncommon and presenting an increasing morbidity and mortality in HSCT recipients. Bleeding and thrombosis, two of controversial disorders, have been posing a great threat to patients in the setting of transplantation, and early hemorrhagic complication after HCST is more frequent and subject to more concern by clinical physicians, previous studies have shown the risk of bleeding in HSCT recipients is more than 10-fold higher than neoplastic patients receiving chemotherapy. Meanwhile, thrombosis events, which is characterized by hepatic veno-occlusive diseases (HVOD), transplantation related thrombotic microangiopathy (TA-TMA), and venous thromboembolism (VTE) can not be imprudently ignored with its fatal threat to patients.

Over the last two decades, it has been recognized that the relatively increasing incidence of bleeding and thrombotic complications correlating to the prognosis and quality of life for HSCT recipients. Previous studies have shown that conventional risk factors including graft-versus-host disease (GVHD), infection, thrombocytopenia, the anticoagulation therapy, damage of endothelial cell and conditioning regimen can contribute to the onset of hemostatic disorders in HSCT recipients or can even exacerbate the process. Nevertheless, their roles and detailed pathogenesis in the development of bleeding and thrombosis remain undefined and limited data in Asian population was known about the competing risks of thrombosis and bleeding.

Given the current understanding of hemostatic complication and many unknown mechanisms of relation between thrombosis and hemostasis，we undertook this prospective study to determine the incidence, predictor factors, specific pathogenesis, and survival specially for patients with thrombotic and bleeding complication to better improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients signed their informed consents are enrolled; 2. Patients suffering from hematological diseases and undergoing hematopoietic stem cell transplantation.

Exclusion Criteria:

* 1. Patients who have not signed their informed consents; 2. Patients with previous history of platelet disorder or bleeding diathesis; 3. Patients with inadequate renal function or hepatic function, or other essential organ damage.
Neurobiology of Opioid Dependence: 5 - 5

The purpose of this study is to determine the effect of acute naltrexone pretreatment on the response to yohimbine in healthy volunteers.


Eligibility Criteria:
Please contact site for information.
Autologous Nerve Graft Breast Reconstruction Neurotization

The goal of this observational study is to learn about the improvement of quality of life in accordance with breast neurotization in breast cancer patients. The patient-reported outcome was assessed by questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Patient who receive breast reconstruction
* Patient who is willing to fill in the questionnaire

Exclusion Criteria:

* Patient who receive breast reconstruction for the reason other than breast cancer
Insight Into the UAE Experience With Monoclonal Antibodies (Sotrovimab )

Sotrovimab is a newly developed monoclonal antibody for the treatment of mild and moderate COVID-19 patient, who are at high risk for progression to severe COVID-19, including hospitalization or death. This includes, for example, individuals who are 65 years of age and older or individuals who have certain medical conditions.

The safety and effectiveness of this investigational therapy continues to be evaluated for treatment of COVID-19. Sotrovimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

As the clinical trial results are too preliminary for the drug to enter routine use in UAE the drug approved only for emergency use, until further evidence shows Sotrovimab is effective, so we thought about this study as a tool to assess the success of Emirats Health service (EHS) strategy for fighting against COVID-19 outside the hospital setting.

May 26, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19), as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).

May 28,2021 the UAE Ministry of Health and Prevention approved the investigational drug for emergency use, and Emirats health service considered strategy for fighting against COVID-19 outside the hospital setting, based on this strategy ,special protocol was finalized and approved including initiation of infusion units for the drug in EHS hospital and primary health care centers, all Infection Prevention and Control Precautions were taken inconsideration .

The overall aim of this study is to determine the effectiveness of Sotrovimab infusion in cohort of ambulatory patients with early symptomatic COVID-19 at high risk for hospitalization, in UAE. We expect to assess the Proportion of patients who have progression of COVID-19 through 28 days as defined by visit to a hospital emergency room for management or illness, or hospitalization more than 24 h for acute management of illness or death. files of patients treated from June 2021 till October 2021 will be reviewed and data will be collected based on the protocol approved from MOHAP ethical committee.

Eligibility Criteria:
Inclusion Criteria:

* All cases received Sotrovimab according the EUA protocol.
* All patient aged 13 and above

Exclusion Criteria:

* Sever form of the COVID-19 disease
* Hospitalized patient
* Age less than 13 years old
* BMI less than 25 and no risk factors
Functional Outcome After Cardiac Arrest

Descriptive and prognosis study of the functional outcome after cardiac arrest for the patients awake within the first 15 days.

Functional outcome after cerebral anoxia due to cardiac arrest is poorly documented.. Survival after out of hospital cardiac arrest has improved and long term follow up of the patients is not routinely effective. Patients showing sign of awakening very early are considered in a good outcome group. Nevertheless they can experience some restriction and difficulties when they try to return to their premorbid level of functioning.

We aim to study their long term functional outcome and their level of anxiety, depression, quality of life and caregiver burden as well as their general cognitive functioning. Prognosis factors will be studied in the acute phase.

Eligibility Criteria:
Inclusion criteria :

* age 18 to 85
* Out of hospital cardiac arrest ; cardiac arrest in the ER is eligible
* Glasgow Coma Score ≥ 12 within 15 days after onset
* Living in the parisian area

Exclusion criteria :

* no social security
* Neurological condition (multiple sclerosis, parkinson disease, AMS, stroke) priori to the cardiac arrest
* Psychiatric condition (schizophrenia, severe bipolar syndrome, long term neuroleptic medication, autistic spectrum disorders
* Deafness and blindness
* Neoplasia
* Premorbid limitation of autonomy.
* Difficulties in speaking and writing the French language
Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women

The primary goal of this proposed research deals with estimating the risk of developing type 2 diabetes and metabolic syndrome in women with a history of GDM compared to women without a history of GDM. In addition, this study will attempt to evaluate the effect of parity on the late appearance of type 2 diabetes and metabolic syndrome in this unique population.


Eligibility Criteria:
Inclusion Criteria:

* The study group will include women who gave birth in Shaare Zedek Medical Center between the years 2000 and 2010.
* Women with a GDM history will be identified based on the gestational diabetes clinic files.
* Women without a history of GDM who will be the control group will be identified from the Shaare Zedek Medical Center birth registration records

Exclusion Criteria:

* We established the following exclusion criteria:

  * women who are diagnosed with metabolic syndrome before pregnancy or have type 1 or type 2 diabetes, and
  * women with severe chronic diseases.
Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age with Keratoconus

A Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age With Keratoconus


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of keratoconus

Exclusion Criteria:

* Minimal corneal thickness \< 350 microns
* Non-keratoconic ectatic disease
* Contraindications or hypersensitivities to any required study medications
* Pregnancy or breastfeeding
* Certain concomitant ocular conditions