cyrilzakka/clinical-trials huggingface dataset:
Endometrial Injury Versus Luteal Phase Support in Intrauterine Insemination Cycles

The investigators will try to assess the effect of endometrial injury preceding the intrauterine insemination cycle on the pregnancy rates compared to cycles with luteal phase support and the control group.

Group 1: Endometrial biopsy is performed on days 21-24 of the spontaneous menstrual cycle proceeding the intrauterine insemination (IUI) treatment cycle. Two small biopsies are obtained from anterior and posterior walls of the uterus.

Group 2: Vaginal progesterone gel is administered for luteal phase support from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.

Goup 3: Patients are undergone intrauterine insemination (IUI) cycles stimulated with gonadotropin without any intervention.

The effect of endometrial injury and luteal phase progesterone support on the pregnancy rate in patients intrauterine insemination (IUI) cycles stimulated with gonadotropin will be compared in terms of biochemical pregnancy rate, clinical pregnancy rate and ongoing pregnancy rate.

Eligibility Criteria:
Inclusion Criteria:

* Patients are undergone intrauterine insemination with gonadotropin stimulation
* Bilateral patent fallopian tubes revealed by hysterosalpingography or laparoscopy
* After semen preparation for intrauterine insemination, total progressive sperm count \> 5 million

Exclusion Criteria:

* endocrin or metabolic disorders,
* uterine factor,
* pelvic inflammatory disease,
* women with basal follicle-stimulating hormone (FSH) level \>15 IU/mL,
* body mass index (BMI) ≥ 35 kg/m2,
* age ≥ 40 and \< 18 years,
A Phase I/II Study to Evaluate UC1010 Treatment in Premenstrual Dysphoric Disorder (PMDD)

The study is a phase 1/2 study in two parts. In part 1, the primary objective is to assess the pharmacokinetics of UC1010 when administered subcutaneously as a single dose to healthy women. The safety and tolerability of UC1010 is also evaluated in study part 1.

In part 2, the primary objective is to assess the pharmacodynamic effect of UC1010 on premenstrual symptoms in women with Premenstrual Dysphoric Disorder (PMDD) when given during the luteal phase of the menstrual cycle. The pharmacodynamic effect is evaluated through the patients' daily ratings of premenstrual symptoms. In both study parts, two active treatment groups are compared to one placebo group.


Eligibility Criteria:
Inclusion Criteria:

Part 1 -Essentially healthy

Part 2 -Have PMDD according to DSM-IV verified in two menstrual cycles

Exclusion Criteria:

* steroid hormonal treatment during the previous three months
* treatment with psychopharmaceuticals or other treatment for PMS
* history of or a significant medical condition ongoing
* be pregnant or plan a pregnancy within the study period
Botulinum Toxin for the Treatment of Involuntary Movement Disorders

BTX has been used since the 1980s in support of the research mission of NINDS. Initial studies were focused on expanding the applicability of BTX treatment to movement disorders and exploring new indications. We evaluated the efficacy of an alternative serotype, type F. Under other protocols, we continue to study the physiology of movement disorders and BTX response.

The application of BTX therapy to movement disorders requires an understanding of BTX preparation and handling. The treatment must be tailored to the disorder under treatment and to its expression in the individual patient. Users must know the specific techniques of injection, including the use of EMG and ultrasound guidance. This protocol allows us to train physicians in all aspects of the use of BTX. It also provides us with a cohort of patients, receiving a standard method of treatment and with a stable response to BTX injection, for participation in other protocols on movement disorders and on the responses to BTX injection.

The efficacy of botulinum toxin (BTX) has now been demonstrated for a variety of diseases associated with involuntary muscles spasms or movement. The application of botulinum toxin therapy to movement disorders requires treatment tailored to the individual patient and specific techniques of injection. This protocol 1) allows us to follow the natural history of subjects with movement disorders who receive standard botox injections for treatment of movement disorders and 2) allows us to provide botulinum toxin injections for patients participating in other NIH studies.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Patients 2 years and older, will be eligible for participation if they have a disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX.
  2. Applicable disorders include but are not limited to dystonia, hemifacial spasm, blepharospasm, tremor, spasmodic dysphonia, tics, vocal fold tremor, oral lingual dyskinesia, tardive dyskinesia, spasticity, and spasmodic dysphonia.

EXCLUSION CRITERIA:

1. Women who are planning on becoming pregnant, are pregnant or breastfeeding, for the duration of the condition.
2. Subjects who require treatment with an aminoglycoside antibiotic, until treatment is complete.
3. For laryngeal injections, subjects must have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders
MEASuRE: Metreleptin Effectiveness And Safety Registry

The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the US and EEA.

This is a non-interventional, multicentre, prospective, observational study of patients receiving treatment with commercial metreleptin for lipodystrophy in the US (GL) and EEA (GL and PL).

This registry will add to the knowledge about metreleptin gained from clinical trials by providing information on the incidence rates of acute pancreatitis associated with the discontinuation of metreleptin; and all cases of fatal or necrotizing pancreatitis, hepatic adverse events, hypoglycemia, hypersensitivity reactions, serious and severe infections, including serious infections resulting in hospitalization and death, loss of efficacy, new diagnoses of autoimmune disorders, exacerbation of existing autoimmune disorders, all cancers (excluding non-melanoma skin cancer) by cancer type, exposed pregnancies, and all-cause deaths, in patients treated with metreleptin in routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with metreleptin through commercial supply at the time or before enrolment into registry
* Patients who provide a written consent
* Patient coming off metreleptin clinical studies and continuing or restarting treatment with metreleptin through commercial supply

Exclusion Criteria:

• Patients currently treated with an investigational agent as part of a clinical trial
SU5416 in Treating Patients With Refractory or Relapsed Multiple Myeloma

RATIONALE: SU5416 may stop the growth of multiple myeloma by stopping blood flow to the cancer cells.

PURPOSE: Phase II trial to study the effectiveness of SU5416 in treating patients who have refractory or relapsed multiple myeloma.

OBJECTIVES: I. Determine the response rate and response duration of patients with refractory or relapsed multiple myeloma treated with SU5416. II. Determine the toxicity of SU5416 in this patient population.

OUTLINE: This is a multicenter study. Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues in the absence of unacceptable toxicity or disease progression. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20-38 patients will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma with an elevated monoclonal protein in serum and/or urine No history of CNS lesion or CNS bleed

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Cytopenias secondary to multiple myeloma involvement of bone marrow allowed Cytopenias not due to multiple myeloma require: WBC at least 3,000/mm3 Platelet count at least 75,000/mm3 Hepatic: Transaminases no greater than 2 times upper limit of normal Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No congestive heart failure, severe peripheral vascular disease, or significant arrhythmia No poorly controlled systolic or diastolic hypertension No uncompensated coronary artery disease No history of myocardial infarction or severe/unstable angina within past 6 months No known hypercoagulable state or deep venous or arterial thrombosis within past 3 months Pulmonary: No pulmonary embolism within past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study No other severe medical or psychiatric condition (e.g., active peptic ulcer, active infection, or history of severe alcohol or drug abuse) No known hypersensitivity to paclitaxel or Cremophor

PRIOR CONCURRENT THERAPY: Biologic therapy: See Chemotherapy Chemotherapy: At least 1 but no more than 3 prior chemotherapy regimens Induction followed by high dose therapy with stem cell support considered a single treatment regimen Tandem courses of high dose therapy considered as 2 regimens Endocrine therapy: At least 1 prior regimen containing steroids Radiotherapy: Prior radiotherapy for symptom control allowed Surgery: At least 3 weeks since prior major surgery At least 1 year since prior coronary artery surgery, angioplasty, or stent placement No prior brain surgery Other: No other concurrent investigational drugs Concurrent bisphosphonates (e.g., pamidronate) allowed
A Study of Epidural Bupivacain-soaked Absorbable Gelatin Sponge on Post-operative Pain in Lumbar Laminectomy

The effective relief of pain is of paramount importance to anyone treating patients undergoing surgery. Post-operative pain increases the possibility of post-surgical complications, raises the cost of medical care, and most importantly, interferes with recovery and return to normal activities of daily living. Therefore pain control is essential in the management of patients undergoing spinal surgery.Parenteral administration of narcotics has been the mainstay for postoperative pain relief in patients undergoing laminectomy and discectomy. Epidural and intrathecal opioids are also effective means of pain control in several major surgical interventions including spinal surgery. However, some of the side effects have limited their widespread use (eg, late-onset respiratory depression). Therefore, alternative measures of pain control including infiltration of paraspinal musculature with local anesthetics have been investigated with conflicting results. In situations such as laminectomies, where the epidural space is exposed as part of the surgical procedure, the application of absorbable gelatin sponge soaked in local anesthetics appears to be an alternative for providing postoperative analgesia. By investigating the probable analgesic effects of this method the investigators may relieve post laminectomy pain with minimal side effects and also costs.


Eligibility Criteria:
Inclusion Criteria:

* ASA grade I or III
* scheduled to undergo lumbar laminectomy

Exclusion Criteria:

* Patients who are younger than 18 years of age
* pregnant
* spinal or lateral stenosis
* previous intervertebral disc surgery at that level
* patients with history of chronicity (symptoms \>6 months duration) or coexisting medical conditions such as substance abuse or withdrawal, hyperthyroidism, anxiety disorder, affective disorder, hepatic or renal impairments
Differential Immune Effects of Natalizumab

Natalizumab is a humanized monoclonal antibody directed against Very Late Activation Antigene 4 (VLA-4) and has a potent effect on disease activity in multiple sclerosis (MS). A blockade of VLA-4 with natalizumab may not only interfere with autoimmunological processes but also with central nervous system (CNS) immune surveillance.

Longitudinal ex vivo and in vitro study to determine the effect of natalizumab on frequency of distinct immune cells and on the frequency and suppressive function of natural CD4+CD25+ regulatory T cells (Tregs).

Eligibility Criteria:
Inclusion Criteria:

* relapsing remitting MS
* indication for natalizumab treatment

Exclusion Criteria:

* other disease modifying agents within 2 weeks
Plexus Brachialis Block. Better to do by Start Than by End of Surgery?

The aim of the study is to find out if the timing of brachial plexus block, before or after surgery, has an impact of the extent of acute postoperative surgical pain or the incidence and severity of long-lasting (chronic) pain after surgery.

This is a prospective, randomized, double blind study in patients with radial fractures undergoing surgery with volar plate. The patients will be followed up for 6 months after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Radial fracture
* ASA 1 and 2
* Able to communicate in norwegian
* Suitable for surgery in general anaesthesia and brachial plexus block

Exclusion Criteria:

* Pregnancy
* Chronic pain
* BMI over 35
A Study to Investigate the Genetic Variation of Dopamine Pathway in Patients With Chronic Pain

Patients having completed former trials T1001-01 or T1001-02 will undergo one blood sampling for genotyping purposes. In addition they will compete the personality questionnaires they had completed in the former trial.


Eligibility Criteria:
Inclusion Criteria:

* have completed T1001-01 or T1001-02 study (Visit 5 completed)
* are men or women of at least 18 years of age
* have given written informed consent approved by the relevant Ethics Committee governing the study sites

Exclusion Criteria:

* have any close relationship with the Investigators or the Sponsor
* are under legal protection, according to the national law
Paravertebral Block to Reduce the Incidence of New Onset Atrial Fibrillation After Cardiac Surgery

The purpose if this pilot study is to determine if a perioperative infusion of 0.2% ropivacaine via bilateral T3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary CABG and/or valve surgery and compare a number of secondary outcomes.

Patients in the intervention group will have ultrasound guided bilateral T3 paravertebral catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5% lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter during and after surgery. Patients in the control group will receive no block and undergo surgery with routine anesthetic care guided by their cardiac anesthesiologist.

Eligibility Criteria:
Inclusion Criteria:

- Participants must be undergoing one of the following elective or urgent (but not emergent) surgeries: A) Primary Coronary Artery Bypass Graft (CABG) B) Primary Surgical Aortic Valve Replacement (sAVR) C) Primary Surgical Mitral Valve Replacement (sMVR) D) Combined CABG \& surgical valve replacement

Exclusion Criteria:

* History of atrial fibrillation or flutter
* Infective endocarditis
* Left ventricular ejection fraction (LVEF) \< 30%
* Emergency surgery
* Redo surgery
* Contraindication to block placement including local anesthetic allergy, bleeding diathesis (physiologic or iatrogenic)
* Body mass index \> 35kg/m2
* Pregnancy
Predictors of Caregiver Adaptation to Pervasive Developmental Disorders

This study will explore predictors of how caregivers might adapt to children diagnosed with a pervasive developmental disorder (PDD), including autism, Asperger s syndrome, childhood disintegrative disorder, Rett s disorder or other not specified PDD. PDD presents particular challenges for caregivers because of the communication and socialization challenges of affected children and because of the uncertainty surrounding the cause, prognosis and recurrence risks.

People 18 years of age or older who are the primary caregiver for a child diagnosed with a PDD may be eligible for this study. Participants fill out a survey, either online or in hard copy, that includes information in the following categories:

* How being a caregiver for a child with a PDD has impacted the caregiver.
* How much control the caregiver feels that he or she or others have over certain aspects of their child s PDD.
* What the caregiver thinks caused the child s PDD.
* What coping techniques the caregiver uses in caring for a child with a PDD.
* How uncertain the caregiver feels about his or her child s PDD.
* What the caregiver feels about him- or herself as a caregiver of a child with a PDD.
* General questions about the caregiver, his or her family and the child with a PDD.

This study aims to understand the predictors of adaptation among primary caregivers of children with a pervasive developmental disorder (PDD). PDD presents particular challenges for caregivers because of the communication and socialization challenges of affected children, as well as the uncertainty surrounding the cause, prognosis and recurrence risks. The literature suggests that these challenges may make the process of adapting to having a child with a PDD different than it is for other chronic conditions. This study of caregivers is based on Lazarus and Folkman s Transactional Model of Stress and Coping. A cross-sectional design will be used to investigate the relationships among causal attributions, control perceptions, coping and adaptation. Caregivers will be recruited from support groups, listservs and magazines targeted to autism and other PDDs. Participants will be asked to complete either a web-based or paper survey. The main outcome measure is psychological adaptation to caregiving a child with PDD.

Eligibility Criteria:
* INCLUSION CRITERIA:

Must be 18 or older and the primary caregiver for a child with one of the five diagnosis categorized as a pervasive developmental disorder.

EXCLUSION CRITERIA:

May not be younger than 18 years of age.
Psychological Wellbeing, Physical Activity, and Disability in Fibromyalgia

This study aims to investigate the association between psychological wellbeing, physical activity, and disability in patients with fibromyalgia. Participants will complete self-reported questionnaires to assess psychological wellbeing, physical activity, and disability. The study will use descriptive statistics, correlation analysis, and multiple regression analysis to analyze the data.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of fibromyalgia
* Age between 18 and 70 years old

Exclusion Criteria:

* Unable to complete self-reported questionnaires
* Presence of other chronic pain conditions
A Study to Describe the Switching From a First- or Second-line Disease Modifying Therapy (DMT) to Ozanimod in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)

The purpose of this study is to describe the reasons, therapy, and/or disease for changing first or second line Disease Modifying Therapy (DMT) to ozanimod in participants with Relapsing Remitting Multiple Sclerosis (RRMS).


Eligibility Criteria:
Inclusion Criteria:

* Patients with RRMS according to 2017 revised McDonald criteria
* Patients who switched a previous first or second line DMT to ozanimod between 4 and 12 weeks before the enrollment
* Patient with a MRI performed within three months before the enrollment
* Patient eligible to ozanimod according to SmPC

Exclusion Criteria:

* Patients with clinical forms of MS other than RRMS
* Patients unable to participate for various reasons
* Patients participating in another clinical study with an investigational product if the study considers the switching behavior as an endpoint or objective
* Contraindications to ozanimod according to SmPC

Other protocol-defined Inclusion/Exclusion Criteria apply.
Effect of Fatigue on Core Endurance, Dynamic Balance and Player Performance in Adolescent Football Players

The goal of this clinical study is to investigate the effect of fatigue on balance, core endurance and player performance in adolescent football players. the main questions it aims to answer are:

1. What is the effect of fatigue on balance, core endurance and player performance in adolescent football players?
2. What is the effect of balance on player performance in adolescent football players? participants will be 60 male age from 16 to 18 years selected from Wadi-Degla football club randomly assigned into either fatigue or control group, Each player assessed for core endurance, balance and performance then fatigue protocol applied for the fatigue group and shame protocol for the control group and the repeat all measurements.

This study will be conducted in This pre and post controlled trial aiming at determining the efficacy of fatigue on core endurance, balance and player performance in adolescent football players, this study will be conducted in Wadi-Degla football club.

Players will be randomly assigned into either fatigue or control group. Randomizations will be done using computer random generated numbers.

Fatigue group (F.G): 30 players will be assessed for core endurance, balance and performance then fatigue protocol will be applied and reasses for core endurance, balance and performance after fatigue Control Group (C.G): 30 players will be assessed for core endurance, balance and performance.

Players will be assessed at baseline and fatigue for: balance using (MFT challenge disc),Core endurance, 20-m running sprint and Triple-Hop Test (THT) for perfprmace Will apply RSA as fatigue protocol for the fatigue groupe.

Inclusion criteria:

Players will be included according to the eligibility Criteria

Eligibility Criteria:
Inclusion Criteria:

1. age ranges from 14 to 18 years old
2. Players will selected from Wadi-Degla (2005, 2006 and 2007 football teams )
3. All participants will be free from lower limb injuries for at least 6 months before the study
4. Body mass index will be at optimal (18.5 to 24.9)

Exclusion Criteria:

1. Not regularly trained for at least 6 hours per week
2. Major lower limb injuries for at least 6 months before the study.
3. lower limb surgery for before the study
Defining Reference Ranges for Cerebral Oxygenation In Neonates (COIN) During Immediate Neonatal Transition After Birth

Especially in neonates non-invasive methods are required for monitoring the complex changes during immediate transition after birth to improve assessment of neonate and eventually resuscitation. During this period especially, the brain is vulnerable and monitoring the brain and possible influencing factors of cerebral oxygenation and perfusion are of great interest. To initiate and guide therapies based on cerebral oxygenation, it is important to define reference ranges.


Eligibility Criteria:
Inclusion Criteria:

* Term and preterm neonates observed routinely at the resuscitation desk
* Decision to conduct full life support
* Written informed consent
* Neonates who require no respiratory or medical support

Exclusion Criteria:

* No decision to conduct full life Support
* No written informed consent
* Congenital malformation
* Neonates who require respiratory and/ or medical support