cyrilzakka/clinical-trials huggingface dataset:
Incidence of Non Receptive Endometrium in Obese Women

This study evaluates the incidence of Non Receptive endometrium in obese infertile women compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test, containing 238 genes, identifying the receptivity status of an endometrial sample and diagnosing the patient's Window of Implantation, regardless of the histological appearance of the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.


Eligibility Criteria:
Inclusion Criteria:

* Infertile women: \> 1 year of regular unprotected intercourse without evidence of pregnancy.
* Normal uterus by 2D/3D ultrasound scan and/or hysteroscopy
* No endometriosis
* Presence of both ovaries
* \< 45 years old (in ovum donation, outcome parameters are not affected until this age in all the current published studies).

Exclusion Criteria:

* Hydrosalpinx
* Stage 3-4 endometriosis diagnosed with ultrasound, laparoscopy/ laparotomy.
* Implantation failure (≥ 4 pre-embryos of good quality transferred without pregnancy)
* Recurrent pregnancy loss (≥ 2 pregnancies biochemical / clinical)
Comparison of Ocular Changes by Surgical Menopause Using Optical Coherence Tomography (OCT)

The aim of this study is to investigate the early changes in macular thickness, corneal thickness and intraocular pressure in young women undergoing surgical menopause.

Methods: Eye findings of 30 surgical menopausal (Postoperative 3-6 months) and 48 natural menopause and 22 healty women (control) were evaluated using OCT. Women with no known eye disease, no chronic disease (Diabetes Mellitus, Cardiac Disease any Autoimmune disease) and no migraine in addition to non smokers were included in the study. Women using any hormone and obese women ( BMI \>25 kg/m2) were excluded. Macular and corneal thickness and intraocular pressure (IOP) were measured in both eyes of the women

This prospective case control study was conducted in a tertiary gynecology and obstetrics clinic and eye clinic between 2020 and 2021 with ethics committee approval number 2020 250 ). Informed consent form was obtained from all participants. All participants were outpatients who applied to obstetrics clinic in Batman Training and Research Hospital.

The study started with 105 patient. Based on the study exclusion criteria, 7 patients were excluded from the study. Every patient in the surgical menopause group underwent a hysterectomy and bilateral salpingo-oophorectomy for benign uterine reasons. The patients included in the study were menstruating women with preoperative natural ovarian appearance and benign non ovarian indications, who had undergone hysterectomy and bilateral salpingo-oophorectomy and had no preoperative menopause complaints. Patients younger than 52 years of age who have undergone oophorectomy are patients whose ovaries have been removed either because of patient anxiety due to a family history of cancer or because of adhesions.

Eligibility Criteria:
Inclusion Criteria:

* The patients included in the study were menstruating women with preoperative natural ovarian appearance and benign non ovarian indications, who had undergone hysterectomy and bilateral salpingo-oopherectomy, and had no preoperative menopause complaints. Patients younger than 52 years of age who have undergone oophorectomy are patients whose ovaries have been removed either because of patient anxiety due to a family history of cancer or because of adhesions.
* having a healthy child
* have consented to participate in the study

Exclusion Criteria:

* Chronic disease (such as diabetes, heart disease)
* History of continuous drug use
* Unwillingness to participate in the study Being between the ages of 18-30
Exceed ABT Acetabular Cup Cementless System

A Post-market Clinical Follow-up Study to provide safety, performance and clinical benefits data on the Exceed ABT acetabular cup (implants and instruments) when used in combination with ceramic liners or polyethylene articulating liners bearing Options.

A single-center, cohort observational clinical outcomes study

Study Aim: To collect survivorship and clinical outcomes long-term data confirm-ing safety, performance and clinical benefits of the Exceed ABT ce-mentless cup when used in combination with ceramic and polyeth-ylene articulating liners

Objectives: Primary Objectives:

Clinical performance - as measured by clinical score data (HHS, WOMAC and Oxford Hip Score), radiographic as-sessments and survivorship which will be based on removal of the device.

Secondary Objectives:

Safety will be evaluated by monitoring incidence of adverse events. Length of study: 13 years (3 years enrollment plus 10 years follow-up): Post-operative follow-up visits at: 1, 3, 5, 7 and 10 years

Eligibility Criteria:
Inclusion Criteria:

* Patients who are capable of understanding the doctor's explanations, following his instructions and are able to participate in the follow-up program
* Patient who gave verbal consent to take part in the study at study commencement and written consent retrospectively at 10 years follow-up by signing the informed consent form according to the General data protection Regulation (GDPR) Patient Consent Form"
* Age: =\> 18 years
* Male and Female
* Non- inflammatory degenerative joint disease including osteoarthritis, avascular necrosis \& post traumatic arthritis
* Rheumatoid arthritis,
* Correction of functional deformity
* Revision of failed joint reconstruction or treatment
* Treatment of femoral neck and trochanteric fractures of the proximal femur with femoral head involvement and which are unmanageable using other techniques

Exclusion Criteria:

* Infection, sepsis, and osteomyelitis
* Patients who are unwilling or unable to give consent, or to comply with the follow-up program
* The patient is known to be pregnant or breastfeeding
* Any vulnerable subjects (= individuals whose willingness to volunteer in a clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate)
* Uncooperative patient or patient with neurologic disorders who are incapable of fol-lowing instruction
* Osteoporosis
* Metabolic disorder which may impair bone formation
* Osteomalacia
* Local and distant foci of infection
* Rapid joint destruction, marked bone loss or bone resorption apparent on roent-genogram
* Vascular insufficiency, muscular atrophy, or neuromuscular disease
* Skeletal immaturity
* Morbid obesity
* Foreign body sensitivity. Where suspected, material sensitivity tests are to be made prior to implantation
* Any condition that may interfere with the survival of the implant such as Paget's disease, Charcot's disease, sickle cell anaemia or traits, lower extremity muscular atrophy or neuromuscular disease'
Personalized Prevention of Depression in Primary Care

The main goal is to design, develop and evaluate a personalized intervention to prevent the onset of depression based on Information and Communications Technology (ICTs), risk predictive algorithms and decision support systems (DSS) for patients and general practitioners (GPs). The specific goals are 1) to design and develop a DSS, called e-predictD-DSS, to elaborate personalized plans to prevent depression; 2) to design and develop an ICT solution that integrates the DSS on the web, a mobile application (App), the risk predictive algorithm, different intervention modules and a monitoring-feedback system; 3) to evaluate the usability and adherence of primary care patients and their GPs with the e-predictD intervention; 4) to evaluate the effectiveness of the e-predictD intervention to reduce the incidence of major depression, depression and anxiety symptoms and the probability of major depression next year; 5) to evaluate the cost-effectiveness and cost-utility of the e-predictD intervention to prevent depression.

Methods: This is a randomized controlled trial with allocation by cluster (GPs), simple blind, two parallel arms (e-predictD vs "active m-Health control") and 1 year follow-up including 720 patients (360 in each arm) and 72 GPs (36 in each arm). Patients will be free of major depression at baseline and aged between 18 and 55 years old. Primary outcome will be the incidence of major depression at 12 months measured by CIDI. As secondary outcomes: depressive and anxiety symptomatology measured by PHQ-9 and GAD-7 and the risk probability of depression measured by predictD algorithm, as well as cost-effectiveness and cost-utility. The e-predictD intervention is multi-component and it is based on a DSS that helps the patients to elaborate their own personalized depression prevention plans, which the patient approves, and implements, and the system monitors offering feedback to the patient and to the GPs. It is an e-Health intervention because it is based on a web and m-Health because it is also implemented on the patient's smartphones through an App. In addition, it integrates a risk algorithm of depression, which is already validated (the predictD algorithm). It also includes an initial GP-patient interview and a specific training for the GP. Finally, a map of potentially useful local community resources to prevent depression will be integrated into the DSS.


Eligibility Criteria:
Inclusion Criteria:

* PHQ-9 \<10 at baseline
* Moderate-high risk of depression (predictD risk algorithm score ≥ 10%)

Exclusion Criteria:

* Not have a smartphone and internet for personal use
* Unable to speak Spanish
* Documented terminal illness
* Documented cognitive impairment
* Limiting sensory disorder (e.g. deafness)
* Documented serious mental illness (psychosis, bipolar, addictions, etc.)
Safety and Efficacy of Cariprazine in Schizophrenia

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided informed consent prior to any study specific procedures
* Patients currently meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for schizophrenia (paranoid type, disorganized type, catatonic type or undifferentiated type), as confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID)
* Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCIPANSS) total score ≥ 80 and ≤ 120
* Diagnosis of schizophrenia for a minimum of 1 year before Visit 1
* Patients with normal physical examination, laboratory, vital signs,and/ or electrocardiogram (ECG)

Exclusion Criteria:

* Patients with a DSM-IV-TR diagnosis of Schizoaffective disorder, schizophreniform disorder, other psychotic disorders other than schizophrenia, or bipolar I or II disorder
* Patients in their first episode of psychosis
* Pregnant, breast-feeding, and/or planning to become pregnant and/or breastfeed during the study
* Pervasive developmental disorder, mental retardation, delirium, dementia, amnestic and other cognitive disorders
* Known or suspected borderline or antisocial personality disorder or other DSM-IV-TR axis II disorder of sufficient severity to interfere with participation in this study
* Substance abuse or dependence within the prior 3 months
Vitamin D Deficiency and Placental Calcification in Low-risk Obstetric Population - Are They Related?

Maternal vitamin D deficiency has been suggested to influence fetal and neonatal health. The role of placenta in vitamin D regulation is known but alteration of Vitamin D levels at placental pathologies is unknown. Placental calcification is usually thought to be a physiological aging process. Nevertheless, it can be a pathological change resulting from the effects of environmental factors on the placenta. The aim of the investigators study was to evaluate the relationship between placental calcification and maternal and cord blood 25-hydroxyvitamin-D3 \[25(OH)D\] and calcium concentrations in low-risk obstetric population at term and their consequences.

Vitamin D deficiency is a public health problem prevalent throughout the World. Low blood 25-hydroxyvitamin D3 ( 25OHD ) level was found to be associated with preeclampsia, gestational diabetes, infectious diseases, decrease in fetal bone mineralization, and increase in fetal respiratory infections and infant wheezing \[1\].

Requirement of vitamin D is primarily met by the exposure of skin to sun and secondarily by intake of food. The provision of vitamin D from the skin depends upon melanin pigment, the use of sun screens, age, dressing style and seasonal changes \[1\]. Placenta plays an important role in Vitamin D metabolism during pregnancy and some independent risk factors increasing the risk of placental dysfunction at fetomaternal interface also influence vitamin D metabolism \[2,3\]. Nevertheless, there can be a pathological change resulting from the effects of environmental factors on the placenta .

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy

Exclusion Criteria:

* Foreknown systemic diseases, multiple pregnancy, smoking cigarettes, receiving vitamin D or calcium supplementation.
Impact of Moderate Exercise Training on Vitals and Peak VO2 in Different Age Categories of Adult in COVID-19.

* To determine the impact of moderate exercise training on vitals (BP, HR) in different age categories of adult in COVID-19.
* To determine the Impact of moderate exercise training on Peak VO2 in different age categories of adult in COVID-19
* To determine muscle discomfort due to physical training.

As of 30th January 2020, the outbreak of the novel coronavirus disease, later called COVID-19, was declared a Public Health Emergency. Governments' immediate protective measurements aim to slow down the ongoing spread of the COVID-19 disease.

Coronavirus had infected people exponentially. It has a typical symptom of influenza which includes fever, cough, fatigue sore throat and additional symptoms like breathlessness and diarrhea. There was no specific treatment to cure it and no vaccination to prevent it from further progression. The solitary solution for prevent of this virus was isolation and no gathering, which has caused people to sit in their houses and wash hands.

Literature shows that a significant larger reduction in Blood Pressure was observed in participant performing aerobic exercise. A study shows comparison between African and Asian population with hypertension indicates that Asian participant reduced more BP as compared to African .

Eligibility Criteria:
Inclusion Criteria:

* Cognitively intact
* Age categories (Young adult 17 -30, Middle age adults 31 to 45, old Age Above 45)
* SBP\>120 mm Hg or DBP\>80 mm Hg, and who had no physical limitations that precluded exercise participation were recruited from the general population from Pakistan in COVID era.
* No Regular Exercise since MARCH 2020 (start of COVID era) 3 months at least.

Exclusion Criteria:

* Participant failing to fall in this category would be excluded of the study.
* Uncontrolled hypertension
* Major joint impairment
* Bone fracture in the last 6 months
* Asthmatic patients
Effects of SF for CST Protocol in OT Interns

Specific feedback is considered an important strategy in communication skills training (CST). However, the effects of specific feedback on communication skills have not been comprehensively investigated. Therefore, this study aimed to investigate the effects of specific feedback based on an in-depth assessment tool for CST (CST-SF) in occupational therapy interns' communication skills.

A one-group pretest-posttest study was conducted. Thirty-six interns received CST-SF combined with patient interviews and brief feedback. Each intern completed three interviews with different patients. After the interviews, the interns were given brief feedback based on the Gap-Kalamazoo Communication Skills Assessment Form (GKCSAF) and specific feedback based on the Communication Skills Measure for Therapists. The first and last interviews were assessed by experts, clinical instructors, interns, and patients using the GKCSAF.

Eligibility Criteria:
Inclusion Criteria:

* fourth-year undergraduate students who had started their psychiatry internship

Exclusion Criteria:

* no
Evaluation of a CD4/CD8+ Interferon Gamma Release Assay for Monitoring Anti-Tuberculosis Treatment

Evaluate the possibility of using an IGRA (Interferon-γ Release Assay) test for monitoring the response to anti-tuberculosis therapy by studying the correlation between the variation in the Interferon-gamma (IFN-γ) response to the QFT-Plus test in the two tubes containing antigens and the gold standard for monitoring TB therapy (culture conversion) in patients with slide positive/culture positive and slide negative/culture positive PTB.

Evaluate the level of agreement between the results of the new QFT Access test and the results of the QFT plus and culture in patients diagnosed with active tuberculosis. To evaluate the level of agreement between QFT Access test results and QFT Plus results in healthy controls and contacts.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical symptoms consistent with a high probability of having PULMONARY TB disease (probable case), such that they are receiving or are likely to receive ther-apy for active PTB (therapy must not have been initiated for more than 72 hours before recruitment into the study).
2. Positive sputum smear for AAR
3. Positive culture for mycobacterium tuberculosis (confirmed PTB case).
4. Positive nucleic acid amplification (NAA) test for mycobacterium tuberculosis.

Exclusion Criteria:

1. Taken therapy for active tuberculosis or latent TB infection for more than 72 hours.
2. Culture confirmation of M. tuberculosis not obtained.
3. Age less than 18 years.
4. Immunosuppression: HIV-infection, solid organ transplantation, stem cell transplantation, rheumatoid arthritis.
Assessment of Burden Disease in Patients With Mast Cell Disorders

The symptoms caused by mast cell disorders can have a significant impact on the state of health of individuals, constituting a real burden for them, and consequently altering their quality of life. It therefore seems important to clarify the impact on the quality of life, on the psycho-affective sphere, on professional life and on the direct and indirect costs caused by the disease, as well as on the "patient's remaining burden". It seems possible by a longitudinal study (patient follow-up over 1 year).

Primary objective is Assessment of quality of life in adult patient with mast cell diseases at M0.

Mast cell activation symptoms are due to the release of mast cell mediators after uncontrolled activation of mast cells. The release by mast cells of mast cell mediators (tryptase, histamine, prostaglandins, serotonin) results in mast cell activation symptoms, found in mast cell activation syndrome but also in mastocytosis. These symptoms interested the skin, gastrointestinal gut, pulmonary, cardiovascular and neuropsychiatric organs, etc.

In mastocytosis, along with these symptoms of mast cell activation, the infiltration of different organs by abnormal mast cells produces many clinical signs related to the excess of monoclonal mast cells present in the organs.

According to our clinical experience, the impact of mast cell disorder on various dimensions of life, including economic life, seems important, but it has never accurately evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient (\> 18 years old) with confirmed mast cell disorder according to international criteria
* Patient affiliated to social security regime

Exclusion Criteria:

* Patient under legal protection (guardianship, curators or court order)
* Patient does not speak French
Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164

The purpose of this study is to obtain information on the long-term safety, tolerability, and therapeutic benefit of extended release ropinirole XL, and to provide a mechanism for patients who participated in either Study 167 or Study 164 to continue receiving ropinirole XL if they chose to do so.


Eligibility Criteria:
Inclusion Criteria:

* Males or non-pregnant/non-breast feeding females
* At least 30 years of age
* Diagnosis of idiopathic Parkinson''s disease (Hoehn \& Yahr criteria)
* Completed either Study 167 or Study 164

Exclusion Criteria:

* Presence of uncontrolled psychiatric, hematological, renal, hepatic,endocrinological, neurological, cardiovascular disease or active malignancy
* Dizziness or fainting due to orthostatic hypotension on standing
* Significant sleep disorder
* Drug abuse or alcoholism
Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).

This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 19 to 50 years
* Body weight 55 to 90 kg and BMI 18.0 to 27.0
* Voluntarily signed the informed consent form
* Eligible according to the screening test results
* Available to follow up after drop-out

Exclusion Criteria:

* Clinically significant disorders or a medical history of hepatic, renal, neurological, respiratory, endocrine, hemato-oncologic, cardiovascular, urological and psychiatric diseases
* Hypersensitivity to donepezil, piperidine derivatives and other drugs
* SBP \<100 mmHg or \>150 mmHg, or DBP \<60 mmHg or \>100 mmHg
* Skin and muscle disorders or history of surgery at the injection site
* AST or ALT \>1.5xULN; QT/QTcB interval \>450 ms
* History or positive result of drug abuse
* Prescribed drugs or herbal medicines within 2 weeks, over-the-counter drugs or vitamins within 1 week
* Participated in other clinical trials within 3 months
* Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month
* Alcohol consumption \>21 units/week
* Smoked \>10 cigarettes/day within 3 months
* Caffeine-containing foods
* Not eligible due to other reasons at the investigator's discretion