bioihbjkbjnl/mcl2 huggingface dataset:
Prolongation of Progesterone Supplementation in Antagonist Cycles and Pregnancy Outcomes
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this study is to evaluate the effect of the prolongation of luteal support
      on the ongoing pregnancy rate (beyond 12 weeks of gestation )in recFSH/GnRH antagonist
      cycles.
    


Intervention name(s): progesterone
Intervention type(s): Drug
Intervention description(s): duration
Other intervention name(s): utrogestan
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: progesterone; antagonist; rec FSH; IVF; pregnancy
Treatment of Obstructive Sleep Apnea in Chronic Kidney Disease
Condition: Sleep Apnea, Obstructive; Renal Insufficiency, Chronic
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency
Study type: Interventional

Summary: 
      This study is being conducted to determine whether treatment of obstructive sleep apnea (OSA)
      in patients with chronic kidney disease (CKD) improves kidney function. Half of the
      participants will receive continuous positive airway pressure (CPAP) treatment for their OSA
      in addition to their regular CKD treatment, while the other half will only receive their
      regular CKD treatment.
    

Detailed description: 
      Obstructive sleep apnea (OSA) and associated hypoxemia during sleep have been associated with
      a decline in kidney function. The abnormalities in kidney function associated with OSA have
      been improved by treatment of OSA with continuous positive airway pressure (CPAP), which is a
      common and effective therapy for OSA. Up to now, clinical research on the impact of OSA on
      kidney function has been performed on patients without CKD. This study will examine the
      impact of CPAP therapy on kidney function in patients with CKD.

      CKD patients with OSA and nocturnal hypoxemia will be randomized into one of two groups where
      half will receive treatment of their OSA with CPAP and the other half will not. All
      participants will have kidney function monitored every 3 months for a year by measurement of
      serum creatinine and proteinuria. The change in estimated glomerular filtration rate (eGFR)
      and proteinuria between the two groups will be assessed to determine whether treatment of OSA
      improves kidney function in patients with CKD.
    

Intervention name(s): CPAP; No CPAP
Intervention type(s): Device; Other
Intervention description(s): Participants randomized into the experimental CPAP therapy arm will receive CPAP in addition to their standard medical therapy for CKD. CPAP will be worn whenever the participant sleeps for the duration of the study.; Participants randomized into the placebo comparator no CPAP arm will receive standard medical therapy for CKD.
Other intervention name(s): Respironics REMstar AutoA-Flex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ketamine on Acute Pain in Females and Males
Condition: Mouth and Tooth Diseases; Tooth, Impacted
MeSH terms: Tooth, Impacted; Tooth Diseases; Stomatognathic Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether equal subanesthetic doses of racemic
      ketamine is equally effective on females and males after surgical removal of third molars
    

Detailed description: 
      Ketamine is assumed to be a NMDA receptor antagonist which provides analgesia from acute
      postoperative pain(and other types of pain) subanesthetic doses. Gender differences in
      ketamine analgesia are not known. This placebo-controlled,randomised, parallel group study
      investigates the analgesic dose-response effect of ketamine in subanesthetic doses in female
      and male patients following surgical removal of third molars.

      Comparisons: Placebo and ketamine in females and males.
    

Intervention name(s): Placebo males; Ketamine 0,1 mg/kg males; Ketamine 0,3 mg/kg males; Ketamine 0,5 mg/kg males; Placebo females; Ketamine 0,1 mg/kg females; Ketamine 0,3 mg/kg females; Ketamine 0,5 mg/kg females
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intravenous saline bolus (Placebo-control) males; 0,1 mg/kg ketamine iv bolus males; 0,3 mg/kg ketamine iv bolus males; 0,5 mg/kg ketamine iv bolus males; Intravenous saline bolus (Placebo-control) females; 0,1 mg/kg iv bolus ketamine females; 0,3 mg/kg iv bolus ketamine females; 0,5 mg/kg iv bolus ketamine females
Other intervention name(s): saline physiological 5 ml; Ketalar ATC-nr.: N01A X03; Ketalar ATC-nr.: N01A X03; Ketalar ATC-nr.: N01A X03; Saline physiological 5 ml; Ketalar ATC-nr.: N01A X03; Ketalar ATC-nr.: N01A X03; Ketalar ATC-nr.: N01A X03
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Wisdom; Tooth; Teeth; Third; Molar
Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children
Condition: Acute Gastroenteritis
MeSH terms: Gastroenteritis; Diarrhea
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To demonstrate the effectiveness of treatment with Bacillus clausii probiotic strain
      (Enterogermina) in combination with oral rehydration therapy (ORT) for a period of 5 days, in
      the duration of acute community-acquired diarrhea in Latin American children.

      Secondary Objectives:

      To evaluate the clinical safety of Enterogermina in acute diarrhea in children and to
      demonstrate its effectiveness on stool frequency, stool consistency, and number of vomiting
      episodes.

      To evaluate parent's overall global assessment. To evaluate the safety and effectiveness of
      Enterogermina in norovirus acute gastroenteritis (AGE).
    

Detailed description: 
      The maximum duration of study participation for each patient can be 10 days.
    

Intervention name(s): Bacillus clausii; Oral Rehydration Therapy
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:aqueous suspension Route of administration: oral; Pharmaceutical form:vials/sachets for solution Route of administration: oral
Other intervention name(s): Enterogermina; Enterolyte
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Objective Vision Evaluation of Two Cosmetic Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a single visit, single site, brand-masked, non-dispensing, 2×2 bilateral crossover
      study. Each subject will be bilaterally fitted with one of the two test articles in each of
      the study periods.
    


Intervention name(s): JJVC Investigational Contact Lens; 1-DAY ACUVUE® DEFINE® Radiant Sweet™
Intervention type(s): Device; Device
Intervention description(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
High Pasta vs. Low Pasta Diet in the Treatment of Obesity
Condition: Diet Therapy
Study type: Interventional

Summary: 
      To the best of our knowledge, the effect of pasta consumption within a hypocaloric
      Mediterranean diet has only been scarcely explored yet. Therefore, a two-parallel group
      dietary intervention was carried out to investigate if pasta consumption could affect the BMI
      change in obese patients. The primary outcome was the loss of at leat 8% of the initial body
      weight in the first 6 months. Anthropometric and body composition (from bioelectrical
      impedance analysis - BIA-) measures were collected every month for the first 6 months and
      after 1 year. In addition, dietary information was collected at baseline and after 3, 6 and
      12 months through a 7-day carbohydrate food record and a 24-h food recall. Blood samples were
      collected at baseline and at 6 and 12 months to assess: glucose, insulin, Homeostatic model
      assessment for insulin resistant (HOMA-IR) index, total cholesterol, low-density lipoprotein,
      high-density lipoprotein, and uric acid. Furthermore, the perceived quality of life was
      investigated through the 36-items short form health survey (SF36) questionnaire.
    


Intervention name(s): High Pasta; Low Pasta
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (at least 5 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations.; Participants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (no more than 3 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Mediterranean Diet; BMI; weight loss; pasta; obesity
Rapid Agitation Control With Ketamine in the Emergency Department
Condition: Violent Aggressive Behavior; Ketamine
MeSH terms: Emergencies; Aggression
Study type: Interventional
Phase: Phase 2

Summary: 
      Compare intramuscular (IM) ketamine to a combination of IM midazolam and haloperidol with
      regards to the time required for adequate behavioral control, in minutes, in patients
      presenting to the emergency department with psychomotor agitation and violent behavior.
    


Intervention name(s): Ketalar; Midazolam injection; Haloperidol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single administration of 5 mg/kg, IM; single administration of 5 mg, IM; single administration of 5 mg, IM
Other intervention name(s): ketamine
Intervention MeSH terms: Midazolam; Ketamine; Haloperidol; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ketamine; aggressive behaviour; midazolam; haloperidol; emergency department
The Pakistan Early Childhood Development Scale Up Trial
Condition: Early Child Development and Growth
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate whether the integration of an early child
      'stimulation and care for development' intervention, either alone or in combination with an
      'enhanced care for nutrition' intervention, delivered by Lady Health Workers to families with
      infants and young children aged 0-24 months living in rural Sindh in Pakistan, has beneficial
      outcomes on child development (cognitive, language, motor and social emotional development)
      and child growth.
    

Detailed description: 
      In Pakistan, the "National Program for Family Planning and Primary Healthcare" delivers
      maternal and child health and nutrition services in rural and remote areas of Pakistan
      through community-based Lady Health Workers. The strengths of the programme include provision
      of services at grassroots levels, reinforcement of health and basic nutrition messages and
      community acceptability. Given, the growing recognition that optimal early child development
      (ECD) also requires the integration of psychosocial care; the PEDS-Trial has been proposed to
      evaluate the benefits of the addition of 'stimulation and care for development' interventions
      and the feasibility of scaling up an ECD strategy within the community healthcare system of
      Pakistan.
    

Intervention name(s): Control; ECD; Enhanced Nutrition
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Integrated early child development, growth and health; Psychosocial stimulation; Care for child development
Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat
Condition: Major Depressive Disorder; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The primary objective of the study is to determine whether quetiapine extended-release in
      combination with cognitive behavioral therapy (CBT) is more effective than CBT plus placebo
      in treating depressive and anxiety symptoms in patients with both major depression and
      generalized anxiety disorder. Approximately 64 individuals (adults 18-65) will be randomly
      assigned to treatment group for 16 weeks. Weekly CBT sessions will be conducted lasting about
      45 minutes and weekly visits with the study psychiatrist lasting about 20 minutes in which
      medication will be discussed. Both clinician administered and self-report measures will be
      used to compare groups before and after 16 weeks.
    

Detailed description: 
      This study will evaluate the efficacy of quetiapine extended-release as adjunctive therapy to
      cognitive behavioral therapy (CBT) compared to CBT plus placebo in the treatment of patients
      with comorbid major depression and generalized anxiety disorder. We will also evaluate the
      quality of life in patients with comorbid MDD/GAD, the response and remission rates by
      treatment group, changes in sleep quality, and tolerability of adjunctive quetiapine to CBT.
    

Intervention name(s): seroquel xr; CBT
Intervention type(s): Drug; Behavioral
Intervention description(s): Quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day; 16 weeks of treatment
Other intervention name(s): quetiapine XR; cognitive behavioral therapy
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: seroquel XR; quetiapine XR; major depression; generalized anxiety disorder; CBT; co-morbid MDD
In Vivo Determination of Cytochrome P450 Activities in Patients With Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      Subjects will receive the "Basel phenotyping cocktail" capsule orally with 120-200ml tap
      water in fasted state. After intake peripheral venous blood samples will be drawn.

      12 patients (male and female) with liver cirrhosis for each Child Pugh Category A, B, and C,
      and 12 age- and gender-matched healthy control subjects will be included (in total 48
      participants).
    


Intervention name(s): "Basel phenotyping cocktail" capsule
Intervention type(s): Drug
Intervention description(s): Oral intake of "Basel phenotyping cocktail" capsule and pharmacokinetics (PK) sampling
Intervention model: Single Group Assignment
Intervention model description: A single center, single dose, open label, single period study to characterize cytochrome P450 (CYP) isoforms by the use of the Basel Phenotyping cocktail in patients at different stages of liver cirrhosis
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: CYP450 phenotyping in patients with liver cirrhosis
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the potential effects of ketoconazole on the
      pharmacokinetics of ibrutinib in healthy participants.
    

Detailed description: 
      This is a single-center, open-label (all people know the identity of the intervention),
      sequential design study in healthy men. All participants will receive ibrutinib on Day 1 and
      ibrutinib in combination with ketoconazole on Day 7. Food will be restricted from the evening
      before dosing until 4 hours after dosing on Days 1 and 7. Following an overnight fast,
      ketoconazole will be given on Days 4 to 6, 1 hour prior to ibrutinib dosing on Day 7, and
      again on Days 8 and 9. All ibrutinib and ketoconazole doses will be administered with water.
      The participants will leave the study center on Day 10.
    

Intervention name(s): Ibrutinib; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): A single oral dose of 120 mg ibrutinib (3 x 40 mg capsules) on Day 1, and 40 mg (1x 40 mg capsule) ibrutinib on Day 7.; Ketoconazole (400 mg [2 x 200 mg] once daily) will be orally administered on Days 4, 5, 6, 7, 8 and 9.
Intervention MeSH terms: Ketoconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Ketoconazole; Ibrutinib
A Single-dose Escalation Safety and PK Study for PLC in Healthy Chinese
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective is to evaluate the effect of single dose Propionyl-L-Carnitine
      Hydrochloride on clinical pharmacokinetic characteristics and its effect of clinical
      pharmacokinetic characteristics and safety on healthy Chinese subjects to provide a basis for
      market authorization registration.
    

Detailed description: 
      Before the official start of the study, to determine the appropriate dosing interval and a
      preliminary assessment of drug safety, first carried out the pre-trial, 4 subjects with
      different gender in half, after 7 days of run-in period, collect baseline background sampling
      point at day 4, no medication but water intake. At day 8 fasting oral propionyl L-carnitine
      hydrochloride tablets 0.5g, according to pre-designed schedule for blood samples, urine
      samples and clinical indicators, provide a reference for official trial.

      Official trial is a single, open label, self-controlled, three-period, dose escalation,
      period fasting single oral administration trial. 12 chinese healthy adult subject met the
      inclusion criteria 12 people, each gender in half. Each subject first pass 7 days of run-in
      period, to eliminate the residual substances in food L-carnitine, stable baseline level of
      endogenous L-carnitine class substance within the subject; at day 4 was baseline sampling
      point, tno medication but water intake; at day 8 (1st period day 1) fasting oral propionyl
      L-carnitine hydrochloride tablets 1g; at day 12 (2nd period of day 1) fasting oral
      hydrochloride propionyl L-carnitine tablets 2g; the first 16 days (3rd period day 1) fasting
      oral propionyl L-carnitine hydrochloride tablets 4g.Throughout the trial period, control the
      subjects' diet, eating only allowed as far as possible food without substance L-carnitine
      class and drink boiled water,diet at sampling day 4, 8, 12, 16 need to be fixed consistently.
      Every 4 days of dosing interval washout period.

      Subject need to follow blood, urine collection and diet control as required by protocol
      before the day of run-in period. During the trial should avoid vigorous exercise, meanwhile
      to avoid long-time bedding.
    

Intervention name(s): Propionyl L-carnitine Hydrochloride
Intervention type(s): Drug
Intervention description(s): 500mg/ tablet; for oral administration, 1 dosage form is set for this trial: 1g, 2g and 4g.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether RPC1063 is effective in the treatment of
      Ulcerative Colitis (UC).
    

Detailed description: 
      The trial is composed of 2 periods: Induction and Maintenance. In the Induction Period (IP),
      patients will be entered into the trial in 2 separate cohorts (Cohort 1 and Cohort
      2).Patients from Cohort 1 and 2 in clinical response at the end of the IP will proceed
      through to the Maintenance Period (MP). Patients from Cohort 1 and 2 who participate in this
      trial may also qualify to participate in an optional Open-Label Extension (OLE) trial.
    

Intervention name(s): RPC1063; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ozanimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ?
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study evaluates the use of the FD2 automated closed loop insulin administration in
      Adolescents with a poor metabolic control . All youth will be treated in a random order by
      their usual pump treatment or an Automated system and we will evaluate whether this has an
      impact on metabolic control and sleep
    

Detailed description: 
      Achievement of a good metabolic control is very important for all persons with diabetes . In
      adolescence many changes occur , physically , socially and psychologically .This may
      influence the metabolic control . This study will evaluate whether the automated closed-loop
      will facilitate and improve the management of diabetes in youth with a poor metabolic
      control.

      It is a single-centre, randomised, two-period crossover study to assess the efficacy /safety
      and acceptability of the automated closed-loop glucose control (CL) day and night, over 28
      days in comparison with continuous subcutaneous insulin infusion (CSII) in the home setting
      in poorly controlled type 1 diabetes adolescents.
    

Intervention name(s): closed loop glucose control system
Intervention type(s): Device
Intervention description(s): Cross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment