bioihbjkbjnl/mcl2 huggingface dataset:
Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin for the Treatment of Bilateral Idiopathic Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objectives of the trial are to assess the safety and efficacy of ProSavin.

      Patients in the trial will have been diagnosed with Parkinson's disease and will be failing
      on current treatment with L-DOPA but they will not have progressed to drug-induced
      dyskinesias. The first stage is an open-label dose escalation to evaluate up to three dose
      levels of ProSavin in cohorts of three patients each. Following a recommendation by the DMC
      the study may proceed to the second stage of the trial, a further 12 patients will be
      recruited to confirm efficacy of the optimal dose in the randomized phase of the study.

      The efficacy of ProSavin will be assessed using the Unified Parkinson's Disease Rating Score
      (UPDRS). Patients will be monitored at regular intervals, with the primary endpoint being an
      efficacy assessment at six months after treatment. The secondary objective of the trial is to
      asses the extent to which patients' current therapy (L-DOPA) can be reduced following
      administration of ProSavin.
    


Intervention name(s): ProSavin; ProSavin
Intervention type(s): Biological; Biological
Intervention description(s): ProSavin is a gene therapy designed to delivery three key enzymes involved in the synthesis of dopamine; ProSavin is a gene therapy designed to delivery three key enzymes involved in the synthesis of dopamine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ProSavin; Parkinson's Disease; Gene Therapy
Effects of The Effects of Dietary Oils on Fasting Lipoprotein Lipids
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional

Summary: 
      The objectives of this clinical trial are to assess the effects of dietary oils on blood
      lipids and other aspects of the fasting lipoprotein profile in healthy men and women with
      elevated cholesterol
    


Intervention name(s): Corn oil; Olive oil
Intervention type(s): Other; Other
Intervention description(s): corn oil 56 g/day for 21 days; olive oil 56 g /day for 21 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: cholesterol,LDL; vegetable oils; heart diseases
High-Dose Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Poor-Prognosis Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining peripheral stem cell transplantation with combinations of
      drugs may kill more tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of high-dose combination chemotherapy
      followed by peripheral stem cell transplantation or autologous bone marrow transplantation in
      women with stage II breast cancer with eight or more positive axillary lymph nodes and in
      women with stage III or metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Investigate the curative potential of high-dose cyclophosphamide, etoposide,
      and carboplatin followed by autologous stem cell rescue in women with breast cancer
      considered incurable by conventional therapy. II. Observe the overall response rate, survival
      rate, and toxicity associated with this regimen.

      OUTLINE: Prior to therapy, patients undergo collection of peripheral blood stem cells (PBSC)
      on another protocol; patients with marrow involvement undergo PBSC harvest only, while all
      others may also undergo bone marrow harvest. All patients receive cyclophosphamide,
      etoposide, and carboplatin over 4 consecutive days, followed 3 days later by PBSC or bone
      marrow and granulocyte colony-stimulating factor. Patients are followed for duration of
      remission and survival.

      PROJECTED ACCRUAL: 100-200 patients will be entered.
    

Intervention name(s): filgrastim; carboplatin; cyclophosphamide; etoposide; mesna; autologous bone marrow transplantation; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention MeSH terms: Cyclophosphamide; Carboplatin; Etoposide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer
Early Pharmacological and Psychological Intervention for Late Prodromal States of Psychosis
Condition: Schizophrenia; Psychoses
MeSH terms: Prodromal Symptoms; Schizophrenia; Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will provide an empirical basis for a pharmacological treatment option. An
      open-label, randomized, multi-centre parallel group design is used. An intensified clinical
      management (CM), which allows needs-based psychological crisis intervention, is compared to a
      combination of such a CM and the atypical neuroleptic amisulpride. The central hypothesis is
      that the combination of a clinical management with an atypical neuroleptic is the superior
      treatment.
    

Detailed description: 
      The first diagnosis of schizophrenia is preceded by a long lasting period comprising an
      untreated psychotic and a prodromal state. The duration of untreated psychosis correlates
      with a significant worsening of several outcome variables and persons fulfilling criteria of
      a prodromal state are already suffering from prodromal symptoms and from a significant
      deterioration of social and vocational functioning. However, a sufficient strategy for early
      intervention is still lacking. The study will provide an empirical basis for a
      pharmacological treatment option. An open-label, randomized, multi-centre parallel group
      design is used. An intensified clinical management (CM), which allows needs-based
      psychological crisis intervention, is compared to a combination of such a CM and the atypical
      neuroleptic amisulpride. For analysis 130 patients will be recruited within three years, the
      treatment period is two years.
    

Intervention name(s): Supportive management; Amisulpride
Intervention type(s): Behavioral; Drug
Intervention description(s): The needs-focused intervention could include psychoeducation, crisis intervention, family counselling and assistance with education or work-related difficulties, according to need. Regular psychotherapy was not permitted.; Daily doses could range from 50 to 800 mg, with increments of 50 mg at first step and 100 mg at further steps. As a guideline, it was suggested that the dosage be increased as long as attenuated or brief limited intermittent positive symptoms were present. The interval between such steps should be at least 14 days if brief limited symptoms were absent and the APS score had improved.
Other intervention name(s): Clinical Management; Solian
Intervention MeSH terms: Amisulpride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; psychosis; ultra high risk; prodromal state; early intervention; amisulpride
Drug-Drug Interaction (DDI) Study for TPN171H
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study was to assess the effect of rifampicin,a cytochrome P450
      3A4 enzyme (CYP3A4) induction, on the pharmacokinetics (PK) of TPN171H in chinese healthy
      male subjects ,and assess the effect of itraconazole，cytochrome P450 3A4 enzyme (CYP3A4)
      induction on the PK of TPN171H in chinese healthy male subjects
    


Intervention name(s): TPN171H; Itraconazole; Rifampicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sequence 1：Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6.
Sequence 2：Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.; Sequence 1：Single dose of 10mg TPN171H on Day 1, 200mg Itraconazole(QD) on Days 3-5, 10mg TPN171H and 200mg Itraconazole on Day 6.; Sequence 2：Single dose of 20mg TPN171H on Day 1, 600mg Rifampicin(QD) on Days 3-9, 20mg TPN171H and 600mg Rifampicin on Day 10.
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study In Patients With Insulin Resistance
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 3

Summary: 
      Fluid management study in patients with insulin resistance.
    


Intervention name(s): Avandia
Intervention type(s): Drug
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Insulin resistance vasodilatory response
Safety, Tolerability and Efficacy of ACTIMMUNE® Dose Escalation in Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this phase 3 randomized, multi-center, double-blind, placebo-controlled study
      is to evaluate the efficacy and safety of ACTIMMUNE® (interferon-γ 1b) in the treatment of
      Friedreich's Ataxia (FA) and to evaluate the pharmacokinetic (PK) characteristics of
      ACTIMMUNE® in FA patients.
    


Intervention name(s): Interferon γ-1b; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study drug dose is planned to be escalated on a weekly basis over the first 4 weeks of treatment (from 10 µg/m² to 25, 50, and 100 µg/m²). The dose may be reduced, interrupted, or held based on tolerability. By Week 13, all participants are to be on a stable tolerated dose of study drug in order to continue study participation; the dose may not be further increased after week 13, however, it may be reduced on a case-by-case basis to manage drug-related adverse events (AEs).; The volume of placebo is planned to correspond with volume of study drug that would be given to the participant if the participant was randomized to the study drug arm.
Other intervention name(s): ACTIMMUNE®
Intervention MeSH terms: Interferons; Interferon-gamma
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Interferon gamma
Study of NVN1000 Topical Gel and Topical Gel Vehicle in the Treatment of Moderate to Severe Acne Vulgaris
Condition: Acne Vulgaris; Acne
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to compare the tolerability, safety and efficacy of
      NVN1000 Topical Gel and Topical Gel Vehicle in the treatment of subjects with moderate to
      severe acne vulgaris.
    

Detailed description: 
      The objective of this study is to evaluate the tolerability, safety and efficacy of once
      daily application of NVN1000 Topical Gel for 8 weeks in comparison with its vehicle in
      subjects with moderate to severe acne.
    

Intervention name(s): NVN1000; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Placebo
Other intervention name(s): Nitric Oxide 0.3%; Vehicle Comparator
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acne Vulgaris; Acne
Dexmedetomedine Infusion Versus Fentanyl Infusion for Donor Anlgesia During Living Donor Hepatectomy
Condition: Donor Hepatectomy
Study type: Interventional

Summary: 
      To compare between the analgesic effect of dexmedetomedine infusion versus Fentanyl infusion
      during donor hepatectomy.
    


Intervention name(s): dexmedetomedine; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): intraoperative infusion
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Effects of Spray and Stretch on Postneedling Soreness and Sensitivity After Dry Needling of a Latent Myofascial Trigger Point.
Condition: Pain After Dry Needling
Study type: Interventional
Phase: Phase 2

Summary: 
      Pain after dry needling or injection in the muscle is a frequent secondary effect in the
      treatment of myofascial pain syndrome. In this trial spray and stretch technique is evaluated
      as a method to reduce this soreness. As well, the characteristics and the different factors
      that influence in this pain will be described.
    


Intervention name(s): Spray and stretch
Intervention type(s): Other
Intervention description(s): Physiotherapeutic technique which consist in stretching the muscle while a cold spray is applied on the skin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Stop Menstruation and Pregnancy Rates in Antagonist Protocol
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      The proposal of this study is to evaluate the association between the achievement of ongoing
      pregnancy and hormonal levels on the first day after the period had stopped in rec-FSH/GnRH-
      antagonist cycles.
    

Detailed description: 
      Ovarian stimulation will be achieved by rec- FSH, Puregon® starting on day 2 of the cycle at
      a dose of 200 IU/day. The dose of rec-FSH remains unchanged during stimulation until day 10
      of the cycle. If it is necessary to increase the dose of rec-FSH after 10 days of
      stimulation, or to decrease the dose of rec-FSH due to a risk of OHSS, the patient will be
      dropped out of the study.

      To inhibit premature LH surge daily GnRH - antagonist (orgalutran 0,25mg ) is used from the
      morning of day 6 of stimulation.

      Final oocyte maturation will be achieved by administration of 10.000 IU of HCG (Pregnyl®) as
      soon as ≥ 3 follicles ≥ 17 mm are present. E2 levels should not be criteria for HCG
      administration. Oocyte retrieval will be carried out 36 hours after HCG administration.
      Conventional IVF or ICSI will be carried out. Embryo transfer will be carried out day3 or
      day5 after oocyte retrieval.

      Similar luteal support for all patients with vaginal administration of 600mg natural
      micronised progesterone in three separate doses (Utrogestan® 200mg 3xday) starting one day
      after oocyte retrieval will be used. Hormonal assessment (E2,FSH,LH,Progesterone) will be
      performed at initiation of stimulation, on the first day after the period had stopped and
      every 2 days until the day of HCG administration.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infertility women treated with rec FSH/antagonist protocol
      
Keywords: hormonal values; menstruations; pregnancy; antagonist
Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis
Condition: Gastroparesis; Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Gastroparesis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the blood drug levels of two prescribed medications,
      immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to
      determine which drug is better absorbed in patients with a slow stomach emptying
      (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug
      omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium
      bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a
      protective coating. Immediate-release omeprazole suspension may have a more rapid
      pharmacokinetic profile and greater overall drug absorption in gastroparesis.
    

Detailed description: 
      Hypothesis: Immediate-release omeprazole suspension may have a more rapid pharmacokinetic
      profile and greater overall drug absorption in gastroparesis. This will result in shorter
      time to maximal drug concentration, greater maximal concentration, and greater total area
      under the curve of the concentration vs. time plot.

      Primary Objective: To compare the pharmacokinetics of omeprazole between immediate-release
      suspension and delayed-release capsules in patients with heartburn associated with
      gastroparesis.

      Study design: randomized, open-labeled, crossover treatment for 7 days with 10-14 days
      washout. Pharmacokinetic studies will be performed after 7 days on study drug.
    

Intervention name(s): Immediate-release omeprazole; Delayed-release omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Immediate-release omeprazole 40 mg qam for 7 days; Delayed-release omeprazole 40 mg qam for 7 days
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroparesis; Gastroesophageal reflux disease; heartburn
Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI
Condition: Cystic Fibrosis; Pancreatic Insufficiency
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase II research study is to evaluate the effectiveness of the next
      generation LYM-X-SORB™ in improving the essential fatty acid (EFA) and choline status for
      children and adolescents with Cystic Fibrosis (CF) and pancreatic insufficiency (PI).
    

Detailed description: 
      Fat malabsorption is common in individuals with cystic fibrosis (CF) and pancreatic
      insufficiency (PI). This places them at risk for caloric, essential fatty acid, and choline
      deficiency, which may in turn, lead to growth failure and a poorer clinical course. The
      purpose of this research study is to find whether or not taking LYM-X-SORB™ over an 18-month
      period, every day, will correct the problem people with CF and PI have with absorbing fat and
      choline. Participation will help CF doctors and other healthcare professionals learn more
      about the potential benefits of LYM-X-SORB™ to children and adolescents with CF and PI. These
      benefits may include better absorption of fat, better choline status, better growth in
      height, weight, muscle and bone, better lungs, and improvement of health status.

      The study will enroll a total of 78 participants from Children's Hospital of Philadelphia
      (CHOP) and from several other Cystic Fibrosis Centers. One half of the participants will be
      randomly picked to receive the active powder with the LYM-X-SORB™ supplement and one half
      will receive a placebo (with no active supplement).
    

Intervention name(s): Lym-X-Sorb powder; Placebo powder
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lym-X-Sorb is an organized matrix of lyso phosphatidylcholine (LPC), free fatty acid (FFA) and monoglyceride formulated at 20wt% with flour and sugar. A dosage contains 32 grams of powder and is consumed with food twice a day (6 to 11.9 years old) or three times per day (12 to 17.9 years old) for 18 months.; The placebo is composed of soybean oil, sunflower oil, fully hydrogenated cottonseed oil and flax seed oil dispersed at 16wt% on flour and sugar. The placebo is >99% triglycerides with no trans fatty acids. The fatty acid composition and caloric content is designed to match the active supplement (Lym-X-Sorb). A dosage contains 32 grams of powder and is consumed with food twice a day (6 to 11.9 years old) or three times per day (12 to 17.9 years old) for 18 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Cystic Fibrosis; Pancreatic Insufficiency; LYM-X-SORB™; LXS
Immune Response in the SAPHO Syndrome
Condition: SAPHO Syndrome
MeSH terms: Acquired Hyperostosis Syndrome; Syndrome
Study type: Observational

Summary: 
      The aetiology of SAPHO syndrome seems to involve genetic, infectious and immunological
      components. The investigators examined innate and adaptative immune responses in SAPHO
      syndrome as compared with psoriatic arthritis and rheumatoid arthritis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        SAPHO syndrome patients
      
Keywords: SAPHO syndrome; Innate immunity; TNF alpha; Polymorphonuclear neutrophils; Propionibacterium acnes; Interleukin-8
Study to Evaluate the Safety of Subcutaneous Alemtuzumab in Patients With B-Cell Chronic Lymphocytic Leukemia
Condition: B-CLL
MeSH terms: Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II trial to study the safety and tolerability of subcutaneous alemtuzumab
      administered without dose escalation to patients with advanced B-cell chronic lymphocytic
      leukemia (B-CLL).
    


Intervention name(s): alemtuzumab
Intervention type(s): Drug
Intervention MeSH terms: Alemtuzumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Cross Pin Configurations in Supracondylar Humerus Fracture Treatment: 2 Pins Versus 3 Pins
Condition: Supracondylar Humerus Fracture
MeSH terms: Fractures, Bone; Humeral Fractures
Study type: Interventional

Summary: 
      The objective of this prospective randomized controlled trial is to evaluate and compare the
      outcome of the 2wire vs 3 wire crossed pin configurations in the management of supracondylar
      humeral fractures in children.
    

Detailed description: 
      Fortyfive children with supracondylar humeral fractures were randomly divided into two
      groups. One group was treated with 2 crossed pins and the other group with 3 crossed pins.
      The mean age was 6.04±2.49 (1-12).. The follow-up period was 5 years, with no patients lost
      to follow up.

      Intervention: Twentytwo patients were managed by 2 crossed and 23 by 3 crossed pin method.
      All surgeries were performed by the same surgeon.

      Main Outcome Measurements: Postoperative stability, ulnar nerve injury, range of motions, and
      pin tract infections were evaluated.
    

Intervention name(s): crossed pin configuration
Intervention type(s): Procedure
Intervention description(s): comparison of two crossed pin fixation methods
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment