cyrilzakka/clinical-trials huggingface dataset:
Effect of Vitamin D Oral Supplementation in Poly Csytic Ovarian Women Resistant to Clomiphene Citrate

effect of vitamin D oral supplementation in poly csytic ovarian women resistant to clomiphene citrate

Polycystic ovarian syndrome is the most common endocrine disorder . It is associated with chronic anovulation and infertility. The diagnosis is made by clinical and ancillary investigations revealing the presence of irregular menstrual cycles, an ovulation , Hyperandrgenemia , and the presence of polycystic ovaries (ovarian morphology as the presence of 12 or more follicles measuring 2-9 mm in diameter and an increased ovarian volume \>10 cm 3) ovulation can be induced with clomiphene citrate (CC), However, \~20%-25% of anovulatory women with PCOS do not respond to CC and are considered to be "clomiphene-resistant( clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days ) Vitamin D may serve as a key in preventing and attenuating the insulin resistance. Vitamin D plays a physiologic role in reproduction including ovarian follicular development and luteinisation, follicle-stimulating hormone sensitivity and progesterone production in human granulosa cells. It also affects glucose homeostasis .

In this trial 100 women with PCO disease that diagnosed by ROTTERDAM CRITERIA (must have any TWO of This findings: Hyperandrogenism, Oligomenorrhea, Polycystic ovaries). Who are taking clomiphene citrate for induction of ovulation and resistant to it, which means failure to ovulate with 3 months of usage of clomid at 150 mg/day for 5 days. They will recieve vitamin D (ossofortin®, Eva Pharma) orally 10000 IU twice weekly for other three months period with clomiphene citrate orally 150 mg/day for 5 days. Number and size of the growing follicles will be monitored before and after taking vitamin D by trans-vaginal ultrasound at day11-14 of the cycle till day 21 to detect effect of vitamin D in ovulation rate.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40 years 2- Polycystic ovarian syndrome diagnosis made according to ESHRE/ASRM criteria.

  1. Polycystic ovaries (either 12 or more follicles or increased ovarian volume \[\> 10 cm3
  2. Oligo-ovulation or anovulation
  3. Clinical and/or biochemical signs of hyperandrogenism (Azziz, 2006). 3- PCOS infertile women resistant to CC for 3 cycles. clomiphene citrate resistance means failure to ovulate with 3 months use of clomid at 150 mg/day for 5 days

Exclusion Criteria:

* Causes of infertility other than PCOS.

  1. Male factor.(normal semen analysis)
  2. Other factors e.g. endometriosis
  3. Tubal factor. (normal hysterosalpingography)
  4. Premature ovarian failure: Day 3 FSH \> 14 mlu/ml or antimullerian hormone \<1 ng/ml.
  5. Normal ultrasound except for criteria of PCO
* Causes of anovulation other than PCOS.
* Patients with hyperprolactinemia
* Patients with thyroid dysfunction.
* Current or in last six months use of vit D treatment.
Effect of Nutritional Counseling Based on Diet Quality on Metabolic Control in Patients With Type 2 Diabetes Mellitus

Randomized clinical trial with outpatient patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre. The study aims to carry out a nutritional counseling directed to offer benefits in metabolic control in diabetic patients.

Randomized clinical trial with outpatient patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre. The study aims to carry out a nutritional counseling directed to offer benefits in metabolic control in diabetic patients. The initial step will be performed analysis of composition and diet quality, and anthropometric and laboratory evaluation. After initial assessment and meeting the criteria eligibility, patients will be randomized to receive nutritional counseling from diet quality (intervention group) or usual diet in according to current nutritional recommendations (control group). Both the groups will receive adjust caloric intake as the nutritional needs of each patient. Patients will be followed over six months, on a monthly basis from hospital visits or telephone monitoring. The outcomes evaluated will be: the achievement of therapeutic targets (fasting blood glucose levels between 70-130 mg / dL, HbA1c\<7%, LDL cholesterol \<100 mg/dL and triglycerides \<150 mg/dL); use of antidiabetic drugs, lipid-lowering and antihypertensive drugs, and adherence to necessary dietary changes.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes patients aged ≥ 30 years;
* Body mass index ≤ 40kg/m²;
* Serum creatinine \<2 mg/dL;
* Serum triglycerides \<400 mg/dL.

Exclusion Criteria:

* Cognitive impairment (clinical suspicion);
* Illiterate;
* Liver function tests and abnormal thyroid;
* Urinary tract infection carriers, kidney disease and heart failure uncompensated (grade III or IV);
* Active wasting disease diagnosis (Cancer, Acquired Immune Deficiency Syndrome);
* Metabolic control within the therapeutic target;
* Patients with dietary guidance by nutritionist in less than three months.
Microdrilling Surgery for Full Thickness Chondral Lesions of the Knee Augmented With Concentrated Bone Marrow Aspirate, Platelet Rich Plasma and Hyaluronic Acid

This study seeks to evaluate a treatment for multiple full thickness chondral lesions in the knee. Eligible subjects will undergo a microdrilling surgery and up to 12 post operative intra-articular injections of bone marrow aspirate concentrate (BMAC), platelet rich plasma (PRP) and hyaluronic acid (HA).


Eligibility Criteria:
Inclusion Criteria: MRI-confirmed full-thickness unipolar or bipolar chondral lesion(s) from osteoarthritis.

Exclusion Criteria:

* Inflammatory arthritis
* Body mass index (BMI) greater than 35
* Presence of significant varus or valgus knee instability or unusually stiff knee
* Greater than 50% deviation of the mechanical axis
* Presence of active cardiac disease
* Presence of active pulmonary disease
* Prior septic arthritis of the involved joint
* Presence of active bacterial or Mycobacterial infection
* Presence of a known hypercoagulable state
* Pregnant or lactating females
* Subject known to be positive for hepatitis B, hepatitis C, or HIV
* Known allergy to hyaluronic acid
* Patients who are unable or unwilling to participate fully in post-operative physical therapy
* Patients with a contraindication to MRI scanning
* Any disorder that compromises ability to give consent or comply with study procedures
* Patients who are felt to be at significantly increased risk for elective orthopedic surgery
* Non-ambulatory patients
* Patients with cognitive impairment
Pre-Approval Access for Administration of Daratumumab Subcutaneously (SC) in Participants Who Are Unable to Receive Intravenous (IV) Daratumumab

The purpose of this pre-approval access (PAA) program is to provide treatment to participants with serious/life-threatening diseases or conditions.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

-
Revascularization Effect on CSVD Burden in Carotid Artery Stenosis

RECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and undergoing revascularization therapy or standard medication treatment alone. The goal of this study is to validate whether CAS revascularization when compared to standard medication treatment alone, can effectively reduce the progression of Cerebral small vessel disease (CSVD) burden, as well as improve the severity of retinal pathologies and cognitive impairment. Therefore, Patients aged ≥ 40 years have more than 50% stenosis in unilateral carotid artery and sign informed consent will be recruited. In this study, patients will be asked to undergo Computed Tomography Angiography (CTA)/ Digital Subtraction Angiography (DSA), Computed Tomography Perfusion (CTP),multimodal Magnetic Resonance Imaging (MRI), Optical Coherence Tomography Angiography (OCTA) and neuropsychological testing. Estimated follow-up can be up to 10 years.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged ≥ 40 years.
2. ≥ 50% stenosis in unilateral carotid artery.
3. Sign informed consent.

Exclusion Criteria:

1. Previous history of major head trauma and any intracranial surgery
2. Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage, and other space occupying lesions
3. Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement.
4. Severe loss of vision, hearing, or communicative ability.
Scapular Stabilization vs Functional Exercises on Chronic Neck Pain

This project is a Randomized clinical trial, will be conducted to check the comparative effects of scapular stabilization versus scapular functional exercises in patients with chronic neck pain. Study duration will be of 8 months, convenient sampling will be done, subject following eligibility criteria from Amina Physical therapy and rehab Centre Lahore, will be randomly allocated in two groups, baseline assessment will be done, Group A participants will be given baseline treatment along with scapular stabilization exercises, Group B participants will be given baseline treatment along with scapular functional exercises. Assessment will be done in 4th week and 8th week via, Visual analogue scale for neck pain, Function of neck will be assessed by Neck disability index and inclinometer measurements of cervical ranges,3 sessions per week will be given, data will be analyzed by using SPSS version 21.

In recent years musculoskeletal related problems are the leading cause of discomfort in people worldwide. Chronic neck pain is among the most commonly reported problems to physicians. Even before reporting to clinics there is long history of using over the counter pain killers. For the duration of rehabilitation in patients who are suffering from chronic neck pain, exercising has been considered one of the maximum proof-based modalities. Rehabilitation exercises that aim to return functionality of the scapular muscles are deemed necessary to render a successful result on chronic neck pain. In previous researches no one explains the specific treatment protocol in scapular exercises. The current study has compared the effects of scapular stabilization exercises and scapular functional exercises protocol and also compare which is more effective for chronic neck pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders.(18-35 years of age)
* Patients having chronic neck pain(\>3 months duration)
* Patient with restricted ROM of cervical.
* VAS≥4(16)
* NDI ≥10

Exclusion Criteria:

* History of Head, Neck, cervical spine and shoulder injury.
* History of cervical radiculopathy
* History of malignancy, scoliosis, torticollis
* Diagnosed cases of disc prolapse, stenosis, herniation, spondylolisthesis, osteoporosis, and those with current use of any medication or physical therapy treatment were excluded.
Nature-based Sensory Stimulation on Pain Levels

This randomized controlled trial aims to evaluate the effect of a single session intervention based on a nature-based stimulation program in patients with fibromyalgia

All participants will continue to receive their usual pharmacological treatment as previously established by the Andalusian Public Health System. The intervention will comprise interaction tasks with biotic and abiotic agents for 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia syndrome (ACR criteria 2016).
* Chronic widespread musculoskeletal pain symptoms (\>1 location using the Widespread Pain Index).
* High-intensity pain (VAS ≥ 4), at least 3 days a week for the previous 3 months.
* If currently taking analgesic or psychotropic medications, they had to be stabilised for four or more weeks before the study enrolment
* Over 18 and less than 65 years old (labour active).
* Ability to speak and understand English or Spanish.

Exclusion Criteria:

* Acute or temporal pain
* Severe cognitive impairment, detected by the Mini-Mental State Examination (score \<24 out of 30 points)
* Severe mental disorders in acute phase or symptomatic phase
* Behavioural alterations as this may interfere in their participation
* Severe intellectual disability
* Other severe or medically unstable diseases interfering with the project participation
* Co-occurrence of neuropathic pain
* Other disorders that may cause pain
* Pregnant or breast-feeding
* Drug abuse within the past year.
Time Restricted Eating Pilot - Bariatrics

Bariatric surgery patients have a variable course of weight loss, maintenance and regain. Time restricted eating is an approach that may help individuals lose weight and improve metabolic functioning. We propose a pilot 12-week trial of a 10-hour time restricted eating intervention among post-bariatric surgery patients. The intervention would consist of weekly sessions for 4 weeks, followed by one session every two weeks through 12 weeks, with weight change as the primary outcome.

We propose a pilot 12-week trial of a 10-hour time restricted eating intervention among post-bariatric surgery patients. The intervention would consist of weekly sessions for 4 weeks, followed by one session every two weeks through 12 weeks, with weight change as the primary outcome. We will provide behavioral weight loss education to the patients and monitor how many calories they are taking in once per week.

Eligibility Criteria:
Inclusion Criteria:

* Participants will be at least two years post bariatric surgery who have completed participation in an ongoing longitudinal assessment study of bariatric patients at our medical center.

Exclusion Criteria:

* Participants who were non-compliant with the previous assessment trial, as well as those who were diagnosed with an eating disorder at their final (2 year) assessment visit. We will exclude participants at the discretion of the investigators who have unstable psychiatric issues or would be too ill to participate.
The Effectiveness of Parent-Child Interaction Therapy (PCIT)

The purpose of this study was to investigate whether a type of parent-based intervention, Parent-Child Interaction Therapy will lower symptoms of behavior problems in young children more than treatment as usual.

Behaviour problems, i.e. symptoms of oppositional defiant disorder (ODD) and conduct disorder (CD) are among the prevalent psychiatric disorders in children and one of the leading causes of help-seeking for mental health problems in children. There are several efficacious treatments for such problems in young children. However, most of these require that parents meet in groups. This is not always feasible. It is therefore a need to develop treatments that can deal with parents and families individually. Parent-Child Interaction Therapy (PCIT) is such an individually based treatment. Efficacy studies indicate symptom reduction greater that in treatment as usual (TAU). However, there is a need to study its effectiveness in ordinary clinical practise. This trial will study its effect in ordinary psychiatric clinics in the middle of Norway and compare it to the regular treatment (TAU) provided to young children with behavior problems in these clinics.

Eligibility Criteria:
Inclusion Criteria:

* Referred to Child mental health specialty clinic for behavioral or attentional/hyperactive problems
* ECBI score of \> 120
* 2 to 7 years of age
* Parental consent to the study

Exclusion Criteria:

* Psychosis or serious drug abuse in parents
* Lack of sufficient proficiency in Norwegian to fill in the questionnaires
* Mental retardation or pervasive developmental disorder in the child
* Suspicion of parental neglect or abuse of the child warranting a report to the child protection services
Identification and Semi-Quantification of Ki-67 Protein Expression Status

The purpose of the study is the identification and semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides.

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples

The anti Ki-67 is a semi-quantitative immunohistochemical (IHC) assay to identify the Ki-67 protein expressions in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Ki-67 test is indicated as an aid in the assessment of the protein status of breast cancer patients. While the p53 kit provides the antibody that offer direct visualization and semi-quantification of the protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the analysis and review of immunohistochemically stained histologic slides.

Eligibility Criteria:
Inclusion Criteria:

* Slides with nuclear borders of tumor nuclei that is distinguishable, and having good integrity.

Exclusion Criteria:

* Slides that have lots of background that interfere with the analysis
Prevalence of the c.853delT Mutation of the HOXB13 Gene in Prostate Cancer in Martinique

In Martinique, prostate cancer incidence rates are nowadays among the highest worldwide with a high incidence of early-onset and familial forms. We identified a rare heterozygous germline variant c.853delT (p.Ter285Lysfs) rs77179853, reported only among patients of African ancestry with a minor allele frequency of 3.2%. We search to estimate the prevalence of this variant in a sample of prevalent prostate cancer cases managed in urology consultation in Martinique .

In Martinique, prostate cancer incidence rates are nowadays among the highest worldwide with a high incidence of early-onset and familial forms. Despite the demonstration of a strong familial component, identification of the genetic basis for hereditary prostate cancer is challenging. The screening of the HOXB13 gene is recommended for men who develop an early-onset and/or familial Pca . In fact, the HOXB13 germline variant G84E (rs138213197) was described in men of European descent with prostate cancer risk. Other germline variants were detected in ethnic groups. More recently, we reported a rare HOXB13 mutation, specifically c.853delT (pTer285Lysfs) that appears to be contribute to young Prostate Cancer cases in Martinique. This variant is a stop loss reported only among patients of African ancestry .

Regarding the allele frequency of the HOXB13 c.853delT variant observed in the Pca cohort, it will be necessary to assess relative and absolute Pca risks for HOXB13 c.853delT carriers. This information is essential to use this variant in genetic counseling. We propose to sequence the HOXB13 gene of all prostate cancers cases managed in urology consultation in Martinique.

Eligibility Criteria:
Inclusion Criteria:

* Adult man over 18 years of age living in Martinique with a prostate cancer whatever the histological type and the stage, managed in urology consultation (public and private sectors of Martinique)
* Sporadic or familial form
* Informed with a written consent signed by the participant and the investigator
* Affiliate or beneficiary of french social security.

Exclusion Criteria:

* Patient who is not of African descent
* Refusal to participate.
* Patients not affiliated to french social security
ELIAS: Early Loop-Recorder in Suspected Arrhythmogenic Syncope

This is a prospective, controlled, opened randomized study to evaluate the cost benefit of a primary implantation of a loop recorder versus the conventional diagnostic cascade for syncope most likely due to cardiac arrhythmia.


Eligibility Criteria:
Inclusion Criteria:

* Two or more episodes of syncope (most likely due to cardiac arrhythmia) of uncertain etiology within the last 12 months or more than one syncope and two presyncopes

Exclusion Criteria:

* Indication for the implantation of a pacemaker
* Indication for the implantation of an implantable cardioverter defibrillator
* Cardiac diseases which need intervention (KHK, aortic stenosis, mitral stenosis, left ventricular \[LV\] outflow stenosis, decompensated heart failure)
* Contraindication for a diagnostic procedure requested by the study protocol
* Enrollment in another study
* Circumstances or comorbidities which do not allow enrollment
Non Enhanced MSCT In Diagnosis of Causes of Acute Abdomen Cases

The acute abdomen is one of the most frequent causes for presentation to the emergency department. Imaging plays an important role for an accurate diagnosis, which in turn diminishes morbidity and mortality Jastaniah and Salih demonstrate optimum CT aspects and emphasize on the important features of CT for those patients presenting with an acute abdominal pain at the Emergency Department. The reported data by this study are based on the author working experience, which forms a continuous protocol adjustment process. The present study provides evidence that CT would result in definite diagnosis of patients with abdominal pain in terms of the detection of some urgent conditions . The acute abdomen may be defined generally as an intra-abdominal process causing severe pain and often requiring medical or surgical intervention. The acute abdomen is a frequent entity at the Emergency Department, the acute abdomen may be life threatening and so rapid diagnosis of patients presenting with acute abdominal pain is required . Diagnostic work-up with imaging can consist of plain X-ray, ultrasonography (US), computed tomography (CT) and even diagnostic laparoscopy. During the last decade, a trend towards increased use of computed tomography in patients with abdominal pain can be seen. In general, acute abdominal pain is responsible for about 10% of total number of patients visiting the emergency. Quick and precise diagnosis for the urgent cases is usually vital for treatment. Medical imaging is commonly used for the diagnosis of most acute abdomen pain. Abdomen and pelvis are reviewed by CT scan. Specifically, in cases of acute abdomen complain.

There is no gold standard for diagnosis of acute abdomen as it still a matter of cooperation between clinical data, radiological and laboratory worker. The aim of this study was to demonstrate optimum CT aspects and emphasize on the important features of CT for those patients presenting with an acute abdominal pain clinically suspected to have emergency operation .

Eligibility Criteria:
Inclusion Criteria:

* Any Case Of Acute Abdominal Pain suspected to be surgical cases in adults.

Exclusion Criteria:

* If pediatric .
* If associated with pregnancy.
* The patient have severe cardiac or respiratory disease ,cant to lie supine.
* If suspected medical case of acute abdomen.