bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Instrumental and Manipulative Techniques for the Suboccipital Region in Subjects With Chronic Mechanical Neck Pain
Condition: Chronic Mechanical Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The aim of the study is to compare the effectiveness between the suboccipital inhibition
      technique, the suboccipital inhibition carried out with the INYBI instrument and the
      suboccipital inhibition with the INYBI plus the upper cervical manipulation, all in patients
      with chronic mechanic cervicalgia, and to determine which of these techniques is the most
      effective in the variables studied. In order to do so, 96 subjects participated in the study,
      being assigned to the 3 intervention groups. We expected the combined treatment (INYBI
      instrument + upper cervical manipulation) to be the one to produce the best results.
    


Intervention name(s): suboccipital inhibition; INYBI; INYBI + upper cervical manipulation
Intervention type(s): Other; Other; Other
Intervention description(s): The therapist will seat at the patient's head height and place his second, third, fourth and fifth fingertips'over the patient's suboccipital area during a 10-minute period.; The therapist will place the INYBI at the suboccipital area, specifically placing the fingers of the instrument at the lower border of the occipital. If needed, a rolled towel will be placed behind the INYBI, in order to maintain the physiological lordosis, checking out that the patient doesn't make a cervical extension. Then the therapist will press the vibration button and turn it off after 10 minutes. All patients will receive the treatment with the INYBI's hardest head with a 50 HZ frequency.; The participant will also be treated with the INYBI during a 10-minute period. After that, the therapist will carry out the upper cervical manipulation technique. Keeping the patient's head on an upper cervical flexion position, the therapist will turn his/her head to the maximum possible rotation, always maintaining its longitudinal axis. Once this is done, a high velocity and short articular amplitude manipulation in rotation will be carried out
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact Program for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effects of a four week diet coaching program on
      pain, fatigue, mood, and dietary habits among adults with multiple sclerosis.
    

Detailed description: 
      Multiple Sclerosis (MS) is the most common chronic disabling central nervous system (CNS)
      disease in young adults, affecting 1 in 1,000 people in Western countries. Disproportionate
      and unpredictable impacts of co-morbid health conditions enhances the needs for comprehensive
      MS management and wellness strategies.

      However, comprehensive care is limited, forcing many people to neglect critical aspects of
      their wellness. This creates a profound need for health and wellness programs that provide
      education, connection, and activation.

      Research shows a consistent need for more access to reliable information regarding symptoms,
      management, access to healthcare professionals, and rehabilitation. There is also a primary
      unmet need for more information on exercise, nutrition, insurance, transportation, and
      employment.

      People living with MS often receive more information from advocacy organizations than their
      MS nurse or neurologist. Decreased access to healthcare professionals since the COVID-19
      pandemic has heightened the need for credible information from organizations like Can Do MS.
      Over the past year, Can Do MS has seen significant growth in virtual program attendance, with
      participant identifying "learning new information" as a critical objective.

      A multipronged approach utilizing auditory, visual, and kinesthetic learning styles is the
      preferred method for delivering information. There is also a need to appeal to multiple
      sensory channels through complimentary mediums (e.g. video, audio, written materials, tactile
      activities).

      We will study the effects of the four week coaching program on dietary patterns in MS
      patients. This will be done through surveys the participants will complete through Qulatrics.
    

Intervention name(s): Impact of four week coaching program on dietary habits
Intervention type(s): Behavioral
Intervention description(s): A registered dietitian will provide dietary coaching via online groups to participants.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Topiramate Trial for Pathological Gamblers
Condition: Pathological Gambling
MeSH terms: Gambling
Study type: Interventional
Phase: Phase 2

Summary: 
      Objectives: Pathological gambling (PG) is a prevalent disorder with no approved
      pharmacological treatment. Previous reports suggest that topiramate could be useful in
      reducing impulsivity in PG, and craving in other addictions. The goal of this study was to
      investigate the effectiveness of topiramate combined with brief cognitive restructuring in
      treating PG. Methods: 38 PG patients were randomized to either topiramate (N=18) or placebo
      (N=20) in a 12-week double-blind trial; all patients received brief cognitive restructuring.
      The main outcome measures were craving, gambling behaviour, gambling cognitive distortions,
      impulsivity, depression and social adjustment.
    


Intervention name(s): Topiramate flexible dosage; Placebo matching tablets; 4-session gambling cognitive restructuring
Intervention type(s): Drug; Drug; Behavioral
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Electromiographic Analysis of the Quadriceps After Trauma
Condition: Leg Injury; Bone Fracture
MeSH terms: Fractures, Bone; Leg Injuries
Study type: Observational

Summary: 
      The lower limb is the region most affected by fractures in the human body. The magnitude of
      the trauma can cause injuries to structures adjacent to the fracture, promoting joint
      instability and consequently predisposition to osteoarthritis. The treatment of fractures can
      be performed conservatively or surgically, and one of the consequences of the surgery is
      arthrogenic muscle inhibition, which presents itself as a marked muscle weakness due to
      inhibition of the central nervous system that prevents adequate muscle activation. However,
      recruiting the quadriceps is the most commonly used goal to determine the patient's return to
      activities. Physiotherapy has several resources for the functional activation of the
      quadriceps muscle, such as neuromuscular electrostimulation (NMES), verbal command of muscle
      activation and neuromatrix techniques. Thus, the objective of this study will be to analyze,
      by means of electromyography, the myoelectric activity of the quadriceps muscle in
      individuals undergoing physical therapy intervention, affected by some fracture of the lower
      limb.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ANALYSIS OF THE QUADRICEPS AFTER TRAUMA IN LOWER MEMBERSINTERVENTION
Sharing History Through Active Reminiscence and Photo-imagery - With MCI
Condition: Cognitive Change
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The SHARP-MCI study tests impact of walking and social reminiscence on cognitive function,
      blood pressure, and weight among healthy Black Americans and those experiencing mild
      cognitive impairment (MCI).
    

Detailed description: 
      For 6 months (24 weeks), triads of healthy and MCI Black adults aged 55 and over walk 3x/week
      (1 mile) in Portland's historically Black neighborhoods. Triads follow GPS-mapped routes
      accessible via the SHARP walking application on a group tablet device. At three points along
      each route, GPS-triggered "Memory Markers" (historical images of local Black culture and life
      from1940-2010) appear on the tablet screen serving as a conversational reminisce prompt as
      the triad walks. At baseline and 24 weeks, cognitive function is measured via the Montreal
      Cognitive Assessment (MoCA), and weight and blood pressure are measured. Pre-post health
      surveys rate activity levels, days feeling downhearted/blue, energy level, and health status.
      Program evaluation surveys at month 1, 3, 6 assess mood, pace and dose of walking, prompt
      effectiveness, program readiness, and liklihood to recommend program to others. Focus groups
      at month 1, 3, 6 evaluate participants' program experience and needed changes.
    

Intervention name(s): Sharing History through Active Reminiscence and Photo-imagery (SHARP)
Intervention type(s): Behavioral
Intervention description(s): Participants engage in neighborhood walks and conversational reminisce three times per week over 24 weeks
Other intervention name(s): SHARP
Intervention model: Single Group Assignment
Intervention model description: single-arm study; all participants are assigned to the experiment
Masking: None (Open Label)
Primary purpose: Prevention
Rituximab in Rheumatoid Arthritis Lung Disease
Condition: Rheumatoid Arthritis; Interstitial Pneumonia
MeSH terms: Pneumonia; Arthritis; Arthritis, Rheumatoid; Lung Diseases, Interstitial
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the course of patients with progressive rheumatoid arthritis
      associated interstitial lung disease (RA-ILD) treated with rituximab for safety and
      progression-free survival at 48 weeks. Safety of rituximab therapy in this disease will be
      assessed through patient history, physical exams and laboratory parameters.

        -  Twelve male/or female patient with RA-associated lung disease (6 of each nonspecific
           interstitial pneumonia (NSIP) and usual interstitial pneumonia (UIP) histological
           subtype) will be enrolled

        -  The study involves 12 visits over 48 weeks

        -  Rituximab will be administered intravenously at Day 1 and Day 15 with repeat dosing at
           six months.
    


Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention description(s): Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months.
Other intervention name(s): Rituxan; MabThera
Intervention MeSH terms: Rituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Interstitial Pneumonia; Rheumatology; Rituximab
Investigation of Chronic Inflammatory Processes in Male Individuals With Hypohidrotic Ectodermal Dysplasia
Condition: X-linked Hypohidrotic Ectodermal Dysplasia
MeSH terms: Ectodermal Dysplasia; Ectodermal Dysplasia 1, Anhidrotic
Study type: Observational

Summary: 
      X-linked hypohidrotic ectodermal dysplasia (XLHED) is a complex genetic disorder
      characterized by lack of sweat, sebaceous, submucous, Meibomian and mammary glands, sparse
      hair and eyebrows, and oligodontia. Insufficient function of the respective glands may lead
      to chronic inflammatory processes in airways and eyes of the affected individuals. The
      investigators will quantify sweat glands of XLHED patients, assess chronic conjunctivitis and
      blepharitis in conjunction with quantitative and/or qualitative alterations of lacrimal fluid
      in these subjects, evaluate lung function and assess chronic inflammatory processes in the
      airways by NO measurements. The data should provide a basis for genotype-phenotype
      correlations.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        subjects with X-linked hypohidrotic ectodermal dysplasia (XLHED) and healthy controls
      
Biospecimen description: 
      tear fluid
Safety and Pharmacokinetics of AT1001 (Migalastat HCl) in Healthy Subjects and Subjects With Impaired Renal Function
Condition: Fabry Disease
MeSH terms: Fabry Disease; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, and pharmacokinetics (PK) study of a single
      dose of 150 mg AT1001 (migalastat HCl, GR181413A) administered orally to healthy subjects
      with normal renal function and to subjects with mild, moderate, and severe renal impairment.
    

Detailed description: 
      This will be an open-label, non-randomized, multiple-center, sequential group, safety,
      tolerability, and PK study of a single dose of AT1001 (migalastat HCl, GR181413A)
      administered orally as a 150 mg dose in fasted healthy control male and female subjects with
      normal renal function compared to mild, moderate, and severe renally-impaired subjects
      (classified by level of creatinine clearance [CLcr] as determined by the Cockcroft-Gault
      formula).

      Screening will occur from Day -28 to Day -2. Subjects will check-in to the clinic on Day -1
      and receive a single oral dose of 150 mg AT1001 on Day 1. Subjects will be discharged from
      the clinic on Day 2 (if stable as determined by the Investigator) and return for daily visits
      on Day 3 through Day 6 for a safety assessment and PK sampling. Subjects will undergo a
      follow-up visit on Day 7 (+1) and an end of study visit on Day 10 (+1).
    

Intervention name(s): AT1001 150 mg
Intervention type(s): Drug
Intervention description(s): AT1001 150mg is available as a capsule
Other intervention name(s): migalastat HCl; GR181413A
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics; GR181413; Safety; AT1001; Migalastat hydrochloride
Levetiracetam in the Treatment of Patients With Premenstrual Dysphoric Disorder (PMDD)
Condition: Premenstrual Dysphoric Disorder
MeSH terms: Premenstrual Dysphoric Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the clinical efficacy of Levetiracetam in the
      treatment of symptoms of premenstrual dysphoric disorder (PMDD) in an open label study.
    


Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): Levetiracetam was started at 250 mg qhs at the end of the first week of the follicular phase. Dose was gradually increased up to 1500 mg bid as tolerated or clinically effective. The treatment phase lasted 4 months.
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PMDD; PMS; Levetiracetam
Comparison of Anesthetic Modalities on Hemodynamic Stability and Postoperative Pain in Diabetic Foot Patients Undergoing Minor Lower Extremity Amputation
Condition: Diabetic Foot Ulcer; Lower Extremity Amputation
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Observational

Summary: 
      Diabetic foot ulcer is the most common cause of non traumatic lower extremity amputations
      (LEA) associated with diabetes. Traditionally general and spinal anesthesia were the
      preferred modality of anesthesia. The use of sciatic nerve block has recently gained
      popularity, however, without the supporting evidence of any benefits. This study was to
      evaluate the comparison of anesthesia modalities for hemodynamic stability and postoperative
      pain in diabetic foot patients undergoing minor LEA.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        consecutive 86 diabetic foot patients who underwent minor LEA
      
Keywords: patients
Administration of a Molecular Complex of Resins, Polysaccharides and Polyphenols in Irritable Bowel Syndrome.
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study is aimed to investigate the efficacy and safety of Colilen IBS, a Medical Device
      made of natural substances, even when taken in addition to other therapies, for the treatment
      of Irritable Bowel Syndrome.
    

Detailed description: 
      This is a Post Market, randomized, double blind, cross-over clinical evaluation that will be
      conducted in 66 patients with diagnosis of Irritable Bowel Syndrome according to Rome IV
      criteria. As this is a cross-over clinical investigation, each eligible patient will take
      both the products under investigation, Colilen IBS and its Placebo.

      After a 2-week run-in period, at Baseline visit each patient included in the study will be
      randomly assigned to one of the two treatment sequences (i.e., Sequence AB and Sequence BA),
      for a 16-week total sequential treatment period (8 weeks for each of the 2 treatment periods)
      first with verum Colilen IBS and then with its Placebo, or vice versa. A wash out period (3
      weeks) is forecast between the two treatment periods.
    

Intervention name(s): Colilen IBS; Placebo
Intervention type(s): Device; Other
Intervention description(s): Patients will take Colilen IBS in First or Second Period; Patients will take PlaceboS in First or Second Period
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Run in period: 2 weeks First Period: two months of treatment with Colilen IBS or Placebo, based on the randomization at Baseline visit Wash out period:3 weeks Second Period: two months of treatment with Colilen IBS or Placebo, based on the randomization at Baseline visit
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Colilen IBS; Abdominal Pain; IBS
Antenatal Detection by Array CGH Genomic Rearrangements Unbalanced Front Uninsulated Thick Neck or a Combination of Two Signs of Ultrasound Calling Normal Karyotype
Condition: Abnormality of the Neck; Fetus; Abnormal, Affecting Management of Pregnancy
MeSH terms: Congenital Abnormalities
Study type: Observational

Summary: 
      This is the first study with a real diagnostic and prognostic focus in prenatal. In addition
      to this innovative aspect, the identification of cryptic imbalances in fetuses with
      malformative syndrome would be an invaluable resource for the identification of new genes
      involved in development, as is already the case for postnatal studies.

      This research aims to:

        1. to test the feasibility of this protocol, ie the practical application of this new
           technology in the context of prenatal diagnosis,

        2. demonstrate and evaluate the possible involvement of cryptic chromosomal abnormalities
           in fetuses with a thick neck associated with other malformations and recruited on the
           strict criteria mentioned above,

        3. assist in the diagnosis of these fetuses and genetic information for their families,

        4. identify new regions of the genome potentially involved in the occurrence of congenital
           malformations.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        the parturients aged 18 to 45 years for whom a karyotype performed from a trophoblast
        biopsy or amniotic fluid puncture is normal or apparently balanced
A Study to Learn About The Study Medicine (Called PF-06823859) in Healthy Chinese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to learn if the study medicine (called PF-06823859) is
      safe and how it is processed in healthy Chinese participants. This study is seeking
      participants who:

        -  Are between 18 to 45 years of age, inclusive, at the time of signing the Informed
           Consent Document (ICD).

        -  Are Chinese participants who are overtly healthy as determined by medical evaluation
           including medical history, physical examination, laboratory tests, and 12 lead ECG
           (electrocardiogram).

        -  Have a BMI (body mass index) of 19 to 27 kg/m2 (inclusive); and a total body weight >50
           kg (110 lb).

      All participants in this study will receive PF-06823859 or a placebo. A placebo does not have
      any medicine in it but looks just like the medicine being studied. PF-06823859 will be given
      as an infusion directly into a vein. We will compare the experiences of people receiving
      PF-06823859 to those of people who do not. This will help us determine if PF-06823859 is safe
      and how it behaves inside the human body.

      Participants will take part in this study for up to 157 days. During this time, they will
      receive PF-06823859 or placebo and be observed for any effects.
    

Detailed description: 
      This is a Phase 1, randomized, double blind, sponsor open, placebo controlled study to
      evaluate the PK, safety, and tolerability following a single dose of PF 06823859 (900 mg) in
      healthy Chinese participants.
    

Intervention name(s): IFN-β inhibitor treatment; Placebo
Intervention type(s): Drug; Other
Intervention description(s): PF-06823859 (IFN-β inhibitor) 100 mg/mL solution for injection; Placebo for PF-06823859, 0 mg/mL solution for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke
Condition: Stroke; Cerebrovascular Disorders; Cerebral Infarction
MeSH terms: Cerebral Infarction; Cerebrovascular Disorders; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT)
      in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.
    

Detailed description: 
      Stroke survivors experience one or more movement-related impairments and activity
      limitations. In this sense, the premotor cortex (PMC) can be considered as an alternative
      locus for post-stroke rehabilitation. In relation to physical rehabilitation protocols,
      associate to neuromodulation, the investigators have chosen a standardized physical therapy
      protocol for this study, the Constraint Induced Movement Therapy (CIMT), which presents
      evidence of good therapeutic results. The investigators hypothesized that applying tDCS and
      CIMT over the PMC promotes motor restoration in stroke patients.
    

Intervention name(s): Transcranial direct current stimulation; Constraint-Induced Movement Therapy
Intervention type(s): Device; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment