bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomized, single dose, two-way crossover bioequivalence study to determine
      the bioequivalence of Flibanserin From AphroFemine 100 mg F.C.T (Bio Med for Pharmaceuticals
      Industries (BIOMED), Egypt) Versus Addyi 100 mg Tablets (Sprout Pharmaceuticals, Inc., USA)
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Flibanserin 100Mg Tab; Flibanserin 100 MG [Addyi]
Intervention type(s): Drug; Drug
Intervention description(s): One tablet contains 100 mg Flibanserin; One tablet contains 100 mg Flibanserin
Other intervention name(s): AphroFemine; Addyi
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
GnRH Agonist Plus Hormone Replacement Therapy vs Hormone Replacement Therapy on IVF Outcomes
Condition: Polycystic Ovary Syndrome; Infertility, Female
MeSH terms: Polycystic Ovary Syndrome; Infertility; Infertility, Female; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is conducted at Arash Women's Hospital on all women undergoing the frozen embryo
      transfer cycle. Patients who signed informed consent will be randomly divided into two
      groups. The first group will receive GnRH agonist plus hormone replacement therapy for
      endometrial preparation. Group 2 will receive hormone replacement therapy. The random
      allocation and final outcome of the study will be assessed by a person who is unaware of the
      study process. Also, the statistician will be unaware of the study process
    


Intervention name(s): Long GnRH agonist + HRT; HRT
Intervention type(s): Drug; Drug
Intervention description(s): Intervention group:(Long GnRH agonist + HRT) From day 18-21 of the previous cycle, 0.5 cc of Superfect is injected daily and vaginal ultrasound is performed 10-14 days later If the endometrial thickness is less than 5 mm and there are no ovarian cysts, estradiol is started like HRT treatment and the agonist dose of GnRH starts with estradiol. It is halved (0.25 cc superfect) and superfect is prescribed until progesterone is started. At the time of progesterone administration, the administration of superfect is discontinued. Injections of estradiol and progesterone is the same as for the HRT group; In the HRT group, from the second day of the cycle, the participant receives 2 mg of estradiol daily and this drug is increased to 6 mg per day in three days.Ten days later, they undergo vaginal ultrasound to check the thickness of the endometrium. If the thickness of the endometrium is greater than 8 mm, inject able progesterone is prescribed and the patient is a candidate for FET transfer. If the thickness is less than 7 mm, it is necessary to increase the dose of estradiol and continue treatment with it. The patient undergoes vaginal ultrasound every three days and if the desired thickness does not reach 21 days after the start of the cycle, the cycle is canceled
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Extension for Community Healthcare Outcomes (ECHO) Autism Diagnostic Study in Primary Care Setting
Condition: Children18-72 Months With a Suspicion Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Observational

Summary: 
      This is a collaborative study that will provide a comprehensive source of observational data
      that can be used to obtain real world evidence of ASD. The study will contain demographic and
      observational clinical data for eligible participants. All decisions regarding patient care
      will be determined by the ECHO Autism Clinician (EAC). All clinical outcomes will be assessed
      by the EAC as would occur in routine clinical practice.
    

Detailed description: 
      The study will be conducted by the University of Missouri ECHO Autism Communities Research
      Team (RT). Research participants recruited by the RT will include: 1) University of Missouri
      ECHO Autism Community trained clinicians (EACs) in both rural and suburban areas across the
      United States; 2)Caregivers/Patients with a suspicion of autism. Caregivers/Patients with a
      suspicion of autism and EACs will complete the informed consent process prior to entering the
      study. Once enrolled, EACs will provide routine clinical care and conduct best-practice ECHO
      Autism diagnostic evaluations with the addition of Canvas Dx to patients who have a suspicion
      of autism spectrum disorder. Canvas Dx will be prescribed; the caregiver will download and
      access the diagnostic app with a code. The caregiver will then complete the following
      activities:

        -  Complete Caregiver Questionnaire in the mobile app

        -  Upload two 90 sec to 5-minute videos of the participant through the mobile app
    

Intervention name(s): Canvas Dx
Intervention type(s): Device
Intervention description(s): Canvas Dx is intended for use by healthcare providers as an aid in the diagnosis of autism spectrum disorder (ASD) for patients ages 18 months through 72 months who are at risk for developmental delay based on concerns of a parent, caregiver, or healthcare provider. The device is not intended for use as a stand-alone diagnostic device but as an adjunct to the diagnostic process. The device is for prescription use only (Rx only)
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Children aged 18-72 months who have a suspicion of ASD.
      
Keywords: Autism
Steroid Titration Against Mannitol IN Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The investigators hypothesise that titration of asthma medication against mannitol challenge
      results will reduce the number of mild asthma exacerbations, in one year, when compared with
      titration against BTS guidelines. To test this hypothesis the investigators propose a primary
      care, parallel treatment, patient blinded study in which matched groups of asthmatic patients
      will be treated in accordance either with BTS guidelines or with our treatment algorithm
      dependent on mannitol challenge result.

      Purpose of the study is to evaluate the efficacy of a treatment algorithm based on the
      measurement of airway hyperresponsiveness to mannitol challenge, a surrogate marker of airway
      inflammation, in the long term treatment of asthma in comparison to BTS guidelines.
    


Intervention name(s): mannitol (an airway challenge agent)
Intervention type(s): Other
Intervention MeSH terms: Mannitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effects of Levcromakalim in Patients With Cluster Headache
Condition: Cluster Headache
MeSH terms: Cluster Headache; Headache
Study type: Interventional

Summary: 
      Cluster headache is a primary headache disorder characterized by attacks of unilateral
      headache of short duration and severe pain intensity. There is an unmet need to understand
      the underlying disease mechanisms that will ultimately lead to the development of
      disease-specific medicines. Until now, it has been suggested that the calcitonin gene-related
      peptide (CGRP) plays a major role in the initiation of a cluster headache attack, possibly
      involving the ATP-sensitive potassium channels. The current study aims to determine whether
      the opening of ATP-sensitive potassium channels triggers cluster headache attacks in patients
      with cluster headache.
    


Intervention name(s): Levcromakalim; Saline
Intervention type(s): Drug; Drug
Intervention description(s): 12 active episodic patients, 15 episodic patients in remission and 20 chronic patients of both genders are randomized to receive a 20-minute infusion of levcromakalim and/or sterile saline on two days, with at least 3 days in between.; 12 active episodic patients, 15 episodic patients in remission and 20 chronic patients of both genders are randomized to receive a 20-minute infusion of levcromakalim and/or sterile saline on two days, with at least 3 days in between.
Other intervention name(s): Isotonic saline; 0.9% saline
Intervention MeSH terms: Cromakalim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the efficacy of tattoo removal using topical
      imiquimod, 5% cream in conjunction with the 1064nm Nd:YAG laser. This procedure for tattoo
      removal will be compared to a laser removal alone.
    

Detailed description: 
      Inclusion criteria includes: patients of both genders with Fitzpatrick skin types I-IV who
      are 18-65 years of age and who has 2 tattoos from 2 to 10 cm in diameter, of similar age
      which contains black and/or blue ink in areas that can be covered. Exclusion criteria
      includes: tattoos in chronically sun exposed areas, larger than 25 cm2,pregnancy,breast
      feeding state, immunosuppressed patients, history of autoimmune or connective tissue
      disorders, hypersensitivity to imiquimod, active sunburn, current tan, use of coumadin,
      aspirin , vitamin E or non-steroidal anti-inflammatory agents for the past 10 days.
    

Intervention name(s): 1064 nm Nd:YAG laser; Imiquimod, 5% cream
Intervention type(s): Device; Drug
Intervention description(s): The laser used will be a 1064 nm Nd:YAG, with a 10ns pulse, 3mm spot size and 4 joules of energy; 2 weeks after the laser procedure the imiquimod will be applied 3 times a week for one month
Other intervention name(s): Aldara
Intervention MeSH terms: Imiquimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tattoos; Black/blue tattoos
The Effectiveness of Rehabilitation Training Based on Brain-computer Interface Technology to Improve the Upper Limb Motor Function of Ischemic Stroke.
Condition: Hemiplegia Following Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Hemiplegia; Ischemia
Study type: Interventional

Summary: 
      To evaluate the effectiveness and safety of rehabilitation training based on brain-computer
      interface in improving the upper motor function, self-care ability in daily life and quality
      of life in patients with ischemic stroke. This study adopts centralized uniform random 1:1
      grouping, subjects will be randomly assigned to the experimental group and the control group.
      Randomization schemes are generated by statistical professionals using SAS software.
    

Detailed description: 
      Brain computer interface(BCI) is a noninvasive nervous system intervention. As a new method,
      it is applied in rehabilitation by stimulating peripheral nerve, such as motor, vibration,
      sensory, in combination with other stimulations, such as transcranial magnetic stimulation,
      transcranial electrical stimulation, etc.

      In traditional rehabilitation therapy, hand-holding training is completed by physical
      therapist. Rehabilitation robot is also used for auxiliary training. BCI therapy will
      stimulate patients to take part in rehabilitation training more actively and obtain better
      effects on the rehabilitation of stroke.
    

Intervention name(s): Brain-computer interface; Traditional rehabilitation
Intervention type(s): Device; Other
Intervention description(s): brain-computer interface rehabilitation training.; traditional rehabilitation training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Brain-computer interface; Electric stimulation therapy; Stroke rehabilitation
Efficacy of Albumin for Acute Encephalopathy in Patients With Cirrhosis
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the administration of albumin in addition
      to the standard care is effective in the treatment of an episode of hepatic encephalopathy in
      patients with cirrhosis.
    

Detailed description: 
      Hepatic encephalopathy is a frequent complication of cirrhosis that is usually associated
      with poor prognosis. The most common presentation is an acute episode of hepatic
      encephalopathy precipitated by factors that increase the exposure of the brain to ammonia.
      Current therapies are based on measures that decrease plasma ammonia and counteract the
      effect of factors such as infection or electrolyte's disturbances. Brain edema and
      abnormalities of cerebral blood flow appear to be important. Part of the impairment of
      astrocyte function could be related to an increase of oxidative stress injury.

      In patients with cirrhosis and hepatic encephalopathy, the concentration of albumin in plasma
      is usually low. Administration of human albumin in patients with hepatorenal syndrome and
      spontaneous bacterial peritonitis has a major impact on the prognosis of these complications.
      Albumin prevents circulatory dysfunction and renal failure. The mechanisms of action may
      include the maintenance of oncotic pressure and a scavenger effect of toxic substances
      present in blood. Albumin has also shown beneficial effects in neurological injury secondary
      to stroke, probably in relation to this scavenger effect.

      The administration of intravenous albumin to patients with hepatic encephalopathy may have
      beneficial effects on the course of encephalopathy.
    

Intervention name(s): Albumin; Sodium chloride 0.9%
Intervention type(s): Drug; Drug
Intervention description(s): Albumin 20%. Day 0: 400-600 ml. Day 2: 200-400 ml.; Day 0: 400-600 ml. Day 2: 200-400 ml.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatic encephalopathy; Cirrhosis; Albumin
Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking
Condition: Chronic Low Back Pain; Lumbar Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this European Union (EU) study to evaluate the safety and performance of the
      CAdiscTM-L Lumbar Spinal Disc Replacement Device in the surgical replacement of the lumbar
      intervertebral discs (L3 to S1) for patients requiring surgical intervention for total lumbar
      disc replacement for the treatment of debilitating, chronic low back pain.
    

Detailed description: 
      Study Design: International, multicenter, open, clinical investigation with comparison to
      pre-operative

      Currently there are two surgical procedures for the treatment of chronic low back pain:
      Spinal fusion and Total Disc Replacement. CAdisc™-L(Compliant Artificial disc - Lumbar) is a
      Lumbar total disc replacement product that preserves motion and restores disc height and
      stability

      Surgical access is via a routine anterior approach with discectomy (removal of the diseased
      disc), which is performed prior to implantation of the CAdisc™-L. Instruments are then used
      to prepare the disc space and to controllably place the replacement disc at the target point.
      It is not intended for the surgery to differ in type, duration or risk to any other device of
      this nature.
    

Intervention name(s): CAdisc™-L (Total Disc Replacement)
Intervention type(s): Device
Primary purpose: Treatment
Keywords: Spine surgery
A Randomized Controlled Trial Comparing Surgical Decompression With an Interlaminar Implant in Patients With Intermittent Neurogenic Claudication Caused by Lumbar Stenosis
Condition: Intermittent Neurogenic Claudication (INC) as a Result of Spinal Stenosis
MeSH terms: Spinal Stenosis; Intermittent Claudication; Constriction, Pathologic
Study type: Interventional

Summary: 
      A Randomized, Blinded Comparison of Surgical Intervention with the Coflex® Interspinous
      Implant versus Surgical Decompression for Patients with Intermittent Neurogenic Claudication
      caused by Lumbar Stenosis
    

Detailed description: 
      In this investigation, it will be investigated whether the effectiveness of surgical
      intervention with Coflex® is equivalent to surgical decompression after 12 months in people
      with intermittent claudication. The main advantage of coflex® might be a faster recovery
      after surgery, but after long term follow-up it is unknown if this treatment effect remains.
      Therefore in addition, it will be investigated whether surgical intervention with coflex® is
      more effective than surgical decompression on short-term follow-up (8 weeks to 6 months) and
      whether surgical intervention with coflex® is more cost-effective after 12 months than
      surgical decompression.
    

Intervention name(s): Decompression
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Weight Loss Counseling for African American Women Who Are Breast Cancer Survivors
Condition: Breast Cancer; Obesity; Weight Changes
MeSH terms: Breast Neoplasms; Body Weight; Weight Loss; Body Weight Changes
Study type: Observational

Summary: 
      RATIONALE: A culturally sensitive weight loss program for obese African American breast
      cancer survivors may be more effective than a standard weight loss program in helping women
      lose weight.

      PURPOSE: This randomized clinical trial is studying personalized weight loss counseling to
      see how well it works in African American women who are breast cancer survivors.
    

Detailed description: 
      OBJECTIVES:

        -  To develop a weight loss intervention for obese African American women who are breast
           cancer survivors.

      OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 intervention
      groups.

        -  Group 1: Participants receive traditional individual dietary and exercise counseling in
           combination with the Weight Watchers weight loss program for 18 months.

        -  Group 2: Participants receive individual dietary and exercise counseling in combination
           with the Weight Watchers weight loss program as in group 1. They also receive spiritual
           counseling that incorporates meditation, readings, and the recording of thoughts into a
           long-term weight management program. The program addresses coping with stress, setting
           priorities, dealing with emotional issues that trigger old behavior patterns, and
           developing accountability for following desired diet and exercise patterns.
    

Intervention name(s): Diet; Spiritual counseling
Intervention type(s): Behavioral; Other
Intervention description(s): Talk to study dietitian (eight in person or by phone) weekly for the first 3 months, every other week for the next 3 months and monthly thereafter.; Spiritual counselor weekly in months 6-9, every other week in months 9-12 and monthly thereafter.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Two groups to participate:

        Group 1: Dietitian led counseling and Weight Watchers groups for 18 months Group 2:
        Dietitian led counseling and Weight Watchers groups for 18 months with Spirituality
        counseling from 6 to 18 months.
      
Keywords: weight changes; obesity; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer
Clinical Factors Associated With Position Sense in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational [Patient Registry]

Summary: 
      Sensory impairment is an important problem for patients with Multiple Sclerosis (MS).
      Although there is no complete loss of sensation in patients, 80% of patients have a
      significant sensory impairment. The sensory system plays an important role in providing the
      feedback required to perform motor tasks. Cutaneous sensation, especially in the sole of the
      foot, is very important in maintaining balance and gait. There are studies showing decreased
      foot sole sensation in MS patients. Another sensation that is important during motor tasks is
      the proprioceptive sensation.

      The aim of this study is to examine the relationship between the sensation of foot sole and
      joint position, clinical features, attention, fatigue, body awareness and physical activity
      level in patients with MS.
    

Detailed description: 
      Patients with MS between 0-5,5 score according to the Extended Disability Status Scale (EDSS)
      and healthy individuals of similar age and sex to patients will be included in the study. The
      sensation of foot sole, joint position sensation, attention, fatigue, body awareness, and
      physical activity level will be evaluated.

      The investigators will use t-tests to compare for quantitative variables and chi-square for
      the categorical variables between groups. In addition, the investigators will examine the
      correlations between the sensation of the foot sole, joint position sensation, attention,
      fatigue, body awareness, and physical activity level using Pearson bivariate correlations.
    

Intervention name(s): Assessment
Intervention type(s): Other
Intervention description(s): Assessments of foot sole sensation, joint position sensation, attention, fatigue, body awareness, and physical activity level
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ambulatory sample
      
Keywords: Multiple Sclerosis; sensation; fatigue; physical activity