bioihbjkbjnl/mcl2 huggingface dataset:
Fasting-Associated Immune-metabolic Remission of Diabetes
Condition: Type 2 Diabetes Mellitus; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      People with a body mass index above 28 kg/m² and an onset of type 2 diabetes within the last
      4 years had a remission (HbA1c <6.5% without medication) of diabetes in over 80% upon weight
      loss of 15 kg. Longer duration of diabetes reduced the chance of remission. The investigators
      will test whether there is a difference in remission upon weight loss of 15 kg using formula
      low calorie diets between subjects with a diabetes duration of <4 years vs. >8 years and oral
      treatment as primary end points. The immune metabolic programming of circulating monocytes
      will be investigated in detail regarding trained innate immunity and the endocrine responses
      will be determined using meal challenge tests.
    

Detailed description: 
      A remission of type 2 diabetes can be achieved in over 80% of people with a diagnosis within
      the last 4 years and overweight or obesity by weight loss of 15 kg. The mechanisms involve an
      improvement of insulin sensitivity and thereby insulin requirements and a regain of the
      function of insulin secreting beta cells. Longer duration of type 2 diabetes appears to
      impair the capacity of beta cell to regenerate. At present it is not possibe to predict
      success of the weight loss at an early time point. The investigators therefore aim to
      identify early markers of responders. It is unclear how the weight loss induces the remission
      in responders. Immune cells are known to contribute to insulin resistance by regulating
      adipose tissue function and hepatic and skeletal muscle metabolism by releasing cytokines.
      The inborn immune system is known to adapt to external stimuli by the process of trained
      immunity and is thought to contribute to insulin resistance and the dysfunction of
      beta-cells. The investigation will analyze the programming state of innate immune cells in
      detail in the course of diabetes remission. In addition, islet hormone responses to challenge
      tests will be performed to assess their function in detail.
    

Intervention name(s): weight loss by very low energy diet intake which may differ in protein or carbohydrate content
Intervention type(s): Behavioral
Intervention description(s): The anthropometric, endocrine and metabolic status is tested before, after 7 days and after 15 kg weight loss
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Obese people with type 2 diabetes with a duration of less then 4 years will be compared with people with type 2 diabetes for more than 8 years regarding their capability to achieve remission of type 2 diabetes in response to a weight loss of 15kg achived using very low calorie intake
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 2 diabetes mellitus in obese; insulin secretion; innate immunity; monocyte programming; remission of type 2 diabetes; weight loss
Pharmacokinetics of Oral Hydroxyurea Solution
Condition: Sickle Cell Disease; Sickle-Cell; Hemoglobin Disease, Thalassemia; Sickle Cell-beta-thalassemia; Sickle Cell Hemoglobin C
MeSH terms: Anemia, Sickle Cell; Thalassemia; beta-Thalassemia; Hemoglobin SC Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      An open label, safety and pharmacokinetic study of oral hydroxyurea solution administered to
      children from 6 months to 17.99 years (i.e. to the day before 18th birthday), with a 12 to 15
      month treatment period for each participant. The study treatment duration will be for 6
      months at the maximum tolerated dose [MTD], which is usually reached by 6 months after
      initiation of treatment. For patients in whom time to MTD is longer than 6 months or not
      achieved at all, the maximum duration of study treatment will be 15 months.
    


Intervention name(s): Hydroxyurea
Intervention type(s): Drug
Intervention description(s): Oral Hydroxyurea
Intervention MeSH terms: Hydroxyurea
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hydroxyurea; Hydroxycarbamide; Xromi
Effect of Transcutaneous Electrical Acupoint Stimulation on Obstetric Quality of Recovery-10 After Cesarean Section
Condition: Recovery
Study type: Interventional

Summary: 
      The primary aim of this prospective and randomized trial is to investigate the effect of TEAS
      on postoperative recovery using the Obstetric Quality of Recovery-10 questionnaire in
      patients undergoing elective cesarean section.
    

Detailed description: 
      Acupoint stimulation is postulated to modulate neurological signal transmission through
      afferent nociceptive pathways. Acupoint stimulation has been associated with positive effects
      on perioperative symptoms such as nausea, pain, and sleep disturbance. Transcutaneous
      electrical acupuncture point stimulation (TEAS) is an acupuncture treatment developed by
      combining traditional Chinese acupuncture with transcutaneous electrical nerve stimulation.
      TEAS has proven to be effective in postoperative pain and nausea-vomiting by applying a
      current of different frequencies, intensities, and waveforms through electrodes adhering to
      the skin. Using TEAS may relieve perioperative symptoms without increasing the risk of
      drug-related adverse events and alleviate and improve the patient's health condition,
      including the postoperative perspective.
    

Intervention name(s): Transcutaneous Electrical Acupoint Stimulation
Intervention type(s): Device
Intervention description(s): Transcutaneous Electrical Acupoint Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ObsQoR-10T; recovery; ceserean; postoperative
Assessment of Drug-Drug Interactions of Androxal With Cytochrome P450 Isoenyzmes in Healthy Males
Condition: Drug-drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to assess the drug-drug interactions of Androxal with
      cytochrome P450 isoenzymes, CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 in healthy
      male subjects administered 25 mg Androxal once daily for 3 days. Secondly, the safety and
      tolerability of Androxal will be determined in healthy male subjects administered Androxal 25
      mg daily for 3 days.
    


Intervention name(s): Androxal; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): enclomiphene citrate
Intervention MeSH terms: Enclomiphene; Clomiphene; Zuclomiphene
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Dose Escalation and Food Effect Study of SKLB1028 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to explore the safety, tolerability and pharmacokinetics (PK)
      of single ascending oral doses of SKLB1028 in healthy subjects. This study has also explored
      the effect of food on the PK of SKLB1028.
    

Detailed description: 
      The study was divided into 2 parts. Part 1(Dose Escalation) included 2 cohorts (Cohort 1 and
      Cohort 2) and subjects received a single oral dose of SKLB1028 50 or 100 mg on Day 1. In Part
      2 (Food Effect) included 2 cohorts (Cohort A and Cohort B), subjects received a single oral
      dose of SKLB1028 150 mg in a fasting and a fed state, with a 10-day washout period between
      the 2 doses.
    

Intervention name(s): SKLB1028
Intervention type(s): Drug
Intervention description(s): SKLB1028, capsule, oral
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability and Pharmacodynamics of CYT013-IL1bQb in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to test safety and tolerability of a vaccine targeting
      Interleukin-1 beta in patients with type 2 diabetes.
    


Intervention name(s): CYT013-IL1bQb; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): s.c. injection; s.c. injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence of ICI176,334-1 in Japanese Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the bioequivalence of ICI176,334-1 in Japanese
      healthy male subjects.
    

Detailed description: 
      Bioequivalence study of ICI176,334-1 in Japanese healthy male subjects - evaluation of
      bioequivalence of ICI176,334-1 and Casodex 80 mg tablet -
    

Intervention name(s): ICI176,334-1; Casodex 80 mg tablet
Intervention type(s): Drug; Drug
Intervention description(s): Subject will receive single dose of ICI176,334-1; Subject will receive single dose of Casodex 80 mg tablet
Intervention MeSH terms: Bicalutamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; pharmacokinetics; safety; bicalutamide; Casodex; Japanese; healthy subject
Inpatient Closed-loop Glucose Control
Condition: Diabetes Mellitus; Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to test an experimental medical device designed to automatically
      control blood sugar. This device was designed for use by patients with diabetes while they
      are in the hospital, and others who may develop high blood sugar as a result of their medical
      problems.
    

Detailed description: 
      The goal of this first-in-man trial is to test the safety and efficacy of the automated,
      closed-loop control system in insulin sensitive subjects with type 1 diabetes, insulin
      sensitive subjects with type 2 diabetes (TTD > 1u/kg/day), and subjects with type 2 diabetes
      and substantial insulin resistance (<2 u/kg/day). The results of this study will help to
      design future studies, exploring the use of the closed-loop system for BG control in
      hospitalized patients, including those with diabetes or hyperglycemia of critical illness.
    

Intervention name(s): Closed-loop blood glucose control
Intervention type(s): Device
Intervention description(s): The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg).
Other intervention name(s): InPatient Closed-Loop Blood Glucose Control Device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Closed-loop blood glucose control; Continuous glucose monitoring; Bionic pancreas; Artificial pancreas
The Effects of Yoga on Patients With Rotator Cuff Injuries
Condition: Rotator Cuff Injuries
MeSH terms: Wounds and Injuries; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      To determine if patients who undergo a 6-week online yoga exercise treatment differ from
      those who undergo a 6-week online standard exercise intervention and patients who do not
      undergo any treatment (the control).
    

Detailed description: 
      Patients awaiting rotator cuff surgery spend months waiting for a doctor's consultation and
      even longer for surgery. The proposed study is to see if there is a difference between three
      groups: patients who follow an online yoga video, patients who follow an online standard
      exercises video and patients who do not undergo either treatment (control).
    

Intervention name(s): yoga; standard exercises
Intervention type(s): Procedure; Procedure
Intervention description(s): patients watch and follow an online yoga video.; patients watch and follow an online standard exercises video.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: rotator cuff, shoulder, rehabilitation, yoga
The Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
Condition: Colonic Diseases, Functional
MeSH terms: Colonic Diseases; Colonic Diseases, Functional
Study type: Interventional
Phase: Phase 2

Summary: 
      To test the efficacy of herbal medicine in relieving symptoms and change of quality of life
      of patients with IBS.
    

Detailed description: 
      Irritable bowel syndrome (IBS) is a diagnosis in Western Medicine characterized by recurrent
      abdominal pain associated with disturbance in bowel habit such as diarrhea or constipation.
      Epidemiological studies showed that 14% of males and 27% of females in the US (white) have
      symptoms of IBS. In Hong Kong, our survey reported a similar prevalence of this condition
      among Chinese (13% in males and 21% in females). IBS is one of the most common conditions
      leading to seeking of medical care. Treatment for IBS has so far been unsatisfactory.
      Numerous medications have been proposed for IBS; however, none is convincingly effective. A
      review and critique of published drug trials for IBS from 1966 to 1988 concluded that there
      was no proof that any western medicine is effective for all IBS patients. With the
      unsatisfactory treatment response of western medicine, many turned to alternative treatment
      modalities for IBS. Traditional Chinese medicine is particularly attractive as their
      effectiveness in treating functional disorders and retaining balance of body functions has
      been known for centuries. However, there is a lack of convincing clinical data demonstrating
      the effectiveness of Chinese medicine in this condition. In this study, we sought to
      determine the efficacy of herbal medicine in relieving symptoms and quality of life of
      patients with IBS. This is a prospective randomized, double-blinded double placebo-controlled
      study in patients with non-constipation type IBS. Patients will be randomized to receive
      either one of three treatment arms: 1. herbal medicine (HM) + placebo western medicine (WM),
      2. WM + placebo HM and 3. placebo HM + placebo WH. Each patient will go through an 8-week
      period of randomized double-blind treatment with either HW, WM or placebo and followed by an
      8-week of observation period. The IBS symptom and quality of life will be compared.
    

Intervention name(s): Traditional Chinese Medicine; Holopon; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): They are Common peony root, Rhizoma Atractylodis Macrocephalae, Radix Paeoniae Lactiflorae, Cortex Magnoliae Officinalis, Rhizoma Curcumae Longae, Fructus Schisandrae Chinensis, Pericarpium Citri Reticulatae, and Rhizoma Corydalis Yanhusuo.; holopon; placebo
Other intervention name(s): TCM; Western Medicine; dummy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Traditional Chinese Medicine
Evaluation of 3 Versus 10 Days of Antibiotics in Skin Abscesses After Surgical Drainage
Condition: Skin Disease, Bacterial; Abscess
MeSH terms: Abscess; Skin Diseases, Bacterial; Skin Diseases
Study type: Interventional

Summary: 
      The objective of this study is to determine if there is a difference in treatment failures
      and recurrent skin infections when patients are given 3 or 10 days of antibiotics for
      uncomplicated skin abscesses after they have been surgically drained.
    

Detailed description: 
      Patients age 3 months to 17 years presenting to a pediatric Emergency Department (ED) with an
      uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10
      days of oral trimethoprim-sulfamethoxazole. Patients were evaluated 10 to 14 days later to
      assess for cure. Patients were contacted 1 month later to determine if they had developed
      another skin infection. Outcomes were also stratified by methicillin-resistent staphylococcus
      aureus (MRSA) and methicillin-sensitive staphylococcus aureus (MSSA).
    

Intervention name(s): Trimethoprim-Sulfamethoxazole
Intervention type(s): Drug
Intervention description(s): 3 versus 10 days of drug
Other intervention name(s): Septra; Bactrim
Intervention MeSH terms: Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Sulfamethoxazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Methicillin resistent Staphylococcus aureus; Staphylococcus aureus
Impact of the Preservation of the Gastric Antrum in the Technique of Sleeve Gastrectomy for the Treatment of the Morbid Obesity
Condition: Obesity, Morbid
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The bariatric surgery is recognized, at present, as the only effective therapeutic for the
      patients with morbid obesity. Two surgical procedures (said restrictive) are considered as
      consensual: the adjustable calibrated horizontal gastroplasty under laparoscopy (ring
      périgastric) and Gastric Bypass under laparoscopy (LGBP). The longitudinal gastrectomy
      (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008). It
      consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/-
      antrum). However, lot of technical disagreements are brought back by expert teams. The most
      important disagreement concerns the conservation or the exeresis of the gastric antrum. In
      fact, the conservation of gastric antrum could facilitate the gastric emptying and to
      decrease the RGO (main complication) and act on the regulations of hormones modulators of the
      insulino-secretion.

      A prospective,randomized study comparing these both techniques is necessary to determine a
      unique consensual technique
    

Detailed description: 
      The main objective of this study is to compare the frequency of post-operative gastronomic
      appearance of gastroesophageal reflux(RGO) between two techniques of longitudinal gastrectomy
      under laparoscopy (gastrectomy coupling sleeve with antrum conservation or without antrum
      conservation) at patients with morbid obesity.

      There are lot of secondary outcomes assessed in this study. In fact, one of secondary
      objectives is to compare between both techniques of longitudinal gastrectomy under
      laparoscopy described in the literature the efficiency on the loss of weight and global
      post-operative morbidity.

      This study assess the impact of these surgery techniques on the comorbidity of the obesity
      and their treatments (type 2 diabetes, arterial hypertension, sleep apnea syndrome,
      arthralgia, dyslipemia).
    

Intervention name(s): bariatric surgery
Intervention type(s): Procedure
Intervention description(s): The longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008).It consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/- antrum). However, lot of technical disagreements are brought back by expert teams. The most important disagreement concerns the conservation or the exeresis of the gastric antrum. In fact, the conservation of gastric antrum could facilitate the gastric emptying and to decrease the RGO (main complication) and act on the regulations of hormones modulators of the insulino-secretion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: morbid obesity; gastrectomy; gastrinaemia; comorbidity; gastric antrum
Efficacy and Safety Study of rTMS for Upper Extremity Motor Function Recovery in Ischemic Stroke Patients
Condition: Stroke; Hemiplegia
MeSH terms: Stroke; Ischemic Stroke; Hemiplegia
Study type: Interventional

Summary: 
      The purpose of this study is to Evaluate Efficacy and Safety of rTMS 『TMS』 for Upper
      Extremity Motor Function Recovery in Patients with Ischemic Stroke
    

Detailed description: 
      Repetitive transcranial magnetic stimulation (rTMS) can modulate the excitability of cortex
      but exact efficacy and safety of rTMS is not well established.

      Eighty four patients will be recruited and will be divided into two groups. Each group will
      receive the real rTMS or sham rTMS, respectively, over the primary motor cortex of the
      dominant hand. Individual subject will receive ten sessions of rTMS. Each rTMS session is low
      frequency (1Hz), total 1800 stimulations.

      The purpose of this study is to evaluate efficacy and safety of rTMS 『TMS』 for upper
      extremity motor function recovery in patients with ischemic stroke.
    

Intervention name(s): Low frequency rTMS
Intervention type(s): Device
Intervention description(s): Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp
Other intervention name(s): TMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neuronal plasticity; Transcranial magnetic stimulation; Stroke; Upper extremity; Function; Recovery
A Study to Evaluate the Efficacy and Safety of Fremanezumab for Preventive Treatment of Migraine in Patients With Major Depressive Disorder
Condition: Migraine; Major Depressive Disorder
MeSH terms: Migraine Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to evaluate the efficacy of monthly 225 mg sc fremanezumab in adult
      participants with migraine and major depressive disorder (MDD)

      The secondary objectives are to evaluate the efficacy of monthly 225 mg sc of fremanezumab in
      adult participants with migraine and MDD on the reduction of MDD symptoms, responder rates in
      monthly migraine days, improving quality of life, improving disability, and the safety and
      tolerability of monthly 225 mg sc and quarterly 675 mg sc fremanezumab in adult participants
      with migraine and MDD.

      The total duration of participant participation in the study is planned to be approximately
      28 weeks.
    


Intervention name(s): Fremanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Monthly 225 mg subcutaneous; Matching Placebo
Other intervention name(s): TEV-48125, LBR-101, PF-04427429, RN307
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention