bioihbjkbjnl/mcl2 huggingface dataset:
Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin,
      may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as
      docetaxel, work in different ways to stop the growth of tumor cells, either by killing the
      cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may
      be an effective treatment for prostate cancer. It is not yet known whether giving hormone
      therapy together with docetaxel is more effective than hormone therapy alone in treating
      prostate cancer.

      PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how
      well they work compared to hormone therapy alone in treating patients with metastatic
      prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare 36-month overall survival of patients with metastatic prostate adenocarcinoma
           treated with hormonal therapy and docetaxel vs hormonal therapy alone.

        -  Compare 24-month progression-free survival (biological progression and/or clinical
           progression) in patients treated with these regimens.

        -  Compare the quality of life of patients treated with these regimens.

        -  Compare costs of these regimens for these patients.

        -  Compare the tolerability of these regimens in these patients.

        -  Compare the toxicity profile of these regimens in these patients.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment
      arms.

        -  Arm I: Patients receive hormonal therapy comprising 1 of the following: goserelin alone
           OR goserelin and antiandrogen therapy OR surgical castration. Hormonal therapy continues
           until the development of hormone resistance. Within 2 months after initiation of
           hormonal therapy, patients receive docetaxel IV every 3 weeks for up to 9 courses in the
           absence of disease progression or unacceptable toxicity.

        -  Arm II: Patients receive hormonal therapy as in arm I. Quality of life is assessed.

      PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.
    

Intervention name(s): antiandrogen therapy; docetaxel; goserelin acetate; orchiectomy
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention MeSH terms: Docetaxel; Goserelin; Androgen Antagonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage IV prostate cancer
A Study of LCZ696 in Subjects With Mild and Moderate Hepatic Impairment Compared With Normal Healthy Volunteers
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to characterize the pharmacokinetics as well as safety and tolerability of a
      single oral dose of LCZ696 200 mg in subjects with mild and moderate hepatic impairment
      compared to matched healthy subjects
    


Intervention name(s): LCZ696
Intervention type(s): Drug
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: hepatic impairment
Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?
Condition: Inflammation; Barrett's Esophagus
MeSH terms: Barrett Esophagus; Esophagitis; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that intensive acid suppression with a long acting high potency
      proton pump inhibitor (PPI) drug dexlansoprazole will lead to a greater decrease in levels of
      inflammatory mediators (compared to conventional PPIs) in the esophagus, which could
      potentially lead to decreased recurrence of intestinal metaplasia following endoscopic
      ablation.
    

Detailed description: 
      Patients who achieve complete remission of intestinal metaplasia following ablation will be
      randomized (using concealed allocation, like the flip of a coin) to either intensive acid
      suppression with dexlansoprazole 60-90 mg/day or to symptom guided acid suppression with
      escalating doses of omeprazole (20-60 mg/day) for 6 months. Control of reflux will be
      assessed using 24 hour ambulatory pH monitoring. The need to escalate drug dosage at the 3
      month visit will be determined by presence of excessive acid exposure on ambulatory pH
      monitoring. Biopsies of esophageal tissue will be obtained at baseline, then at 3 months and
      6 months following randomization to measure changes in inflammatory biomarkers.
    

Intervention name(s): dexlansoprazole; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months; Escalating doses of omeprazole (20-60 mg/day) for 6 months
Other intervention name(s): Dexilant; Prilosec
Intervention MeSH terms: Omeprazole; Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Barrett's Esophagus; Radiofrequency ablation; Patients post-radiofrequency ablation for Barrett's Esophagus.
Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19
Condition: COVID-19 Acute Respiratory Distress Syndrome; Respiration, Artificial
MeSH terms: COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome
Study type: Observational

Summary: 
      Flow controlled ventilation (FCV) is a fairly new mode of mechanical ventilation, consisting
      of a constant inspiratory and expiratory flow. Inspiration is thus comparable to volume
      controlled ventilation (VCV). The actively controlled, constant flow during expiration is
      unique. FCV is known to minimize dissipated energy to the lung [ref] and is therefore
      supposed to aid in lung protective ventilation.

      The VICAR study is designed as a prospective single cohort crossover trial. The intervention
      consists of a sequence of respiratory modes: baseline pressure controlled ventilation (PCV)
      during 5 minutes, followed by 30 minutes of FCV with an evone respirator (Ventinova Medical
      B.V., Eindhoven, The Netherlands) and eventually 30 minutes of VCV. Every participant will
      receive the intervention. Respiratory rate (RR), positive end-expiratory pressure (PEEP) and
      inspiratory fraction of oxygen (FiO2) will be held constant. According to the manufacturers
      guidelines, an I:E ratio of 1:1 will be pursued during FCV. During FCV, the respirator will
      be set with the same PIP as during baseline PCV. For VCV, the same tidal volume as during
      baseline PCV will be set.
    


Intervention name(s): Arterial blood gas (ABG); Recording of hemodynamic monitoring; Recording of respiratory monitoring
Intervention type(s): Diagnostic Test; Other; Other
Intervention description(s): Arterial blood gasses will be drawn during baseline PCV, and every 15 minutes during FCV and VCV respectively. pO2 (mmHg), pCO2 (mmHg) and pH will be recorded.; Hemodynamic parameters (invasive arterial blood pressure (mmHg) and heart rate (beats per minute)) will be recorded every 5 minutes.; Tidal volume (ml), respiratory rate (breaths per minute), minute volume (l/min), dynamic compliance (ml/cmH2O), resistance (cmH2O/l/min), plateau pressure (cmH2O), mean airway pressure (cmH2O), positive end-expiratory pressure (cmH2O), peak inspiratory pressure (cmH2O) and fraction of inspired oxygen will be recorded every 5 minutes.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients requiring mechanical ventilation for moderately severe ARDS (P/F ratio 100-200)
        due to COVID-19 were recruited from a tertiary intensive care unit.
      
Biospecimen description: 
      Point-of-care arterial blood gas sampling. The sample will be disposed as biohazard material
      after analysis is done.
    
Keywords: Flow controlled ventilation (FCV)
Comparison of Cow Milk and 15% Hypertonic Saline in the Treatment of Rectal Prolapse in Children
Condition: Rectal Prolapse
MeSH terms: Rectal Prolapse; Prolapse
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To see the outcome of results of Cow Milk & Hypertonic Saline in the treatment of Rectal
      Prolapse in Children
    

Detailed description: 
      Sclerotherapy is the least invasive procedure used in management of grade I/II rectal
      prolapse, with a success rate of around 80%, and generally considered as the first choice for
      uncomplicated and recurrent prolapse. Several sclerosing agents such as 15% hypertonic
      saline, 5% Phenol in almond oil and cow milk have been used and reported in the literature.
      Present study is designed to determine the efficacy of cow milk and 15% hypertonic saline in
      the management of children with grade I/II rectal prolapse.

      All the details will be entered on the proforma which will include resolvement of rectal
      prolapse and which agent has adverse effects like recurrence, fecal incontinence and anal
      stenosis.
    

Intervention name(s): Hypertonic saline; Cow Milk
Intervention type(s): Drug; Other
Intervention description(s): Hypertonic saline; Cow Milk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
G-CSF Treatment for Amyotrophic Lateral Sclerosis: A RCT Study Assessing Clinical Response
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the effectiveness of G-CSF in treating patients with amyotrophic
      lateral sclerosis (ALS) - a fatal neurological degenerative disease that causes adult-onset,
      progressive motor neurons loss in the spinal cord, brain stem and motor cortex. Patients
      develop progressive wasting and weakness of both upper and lower limbs, bulbar and
      respiratory muscles. Usually death from respiratory failure typically is within 3-5 years of
      diagnosis. Although there are various treatments for ALS, riluzole is the only approved
      treatment to delay the disease progression. G-CSF is an approved drug that is used to
      increase white blood cell counts. Moreover, G-CSF and its receptor are expressed by neurons.
      It acts anti-apoptosis by activating several protective pathways, stimulates neuronal
      differentiation of adult neural stem cells in the brain, and improves long-term recovery.
      G-CSF is a novel neurotrophic factor, and a highly attractive candidate for the treatment of
      neurodegenerative conditions such as ALS.

      Patients 18 to 65 years of age who have had mild to moderately severe ALS for 0.5 to 2 years
      of duration may be eligible for this study. Candidates will be screened with a medical
      history and possible review of medical records, physical examination, blood test, urine and
      stool analyses, electrocardiogram, electrophysiological examination, neurological imaging
      and, for women, a pregnancy test.

      Participants will have drug therapy according to randomized number. One group receives G-CSF
      while other group receives placebo. All of the participants receive riluzole treatment. For
      the procedure, patients are given a medication to lessen anxiety and any discomfort. Patients
      receive drug injections every 3 months for 5 days. The G-CSF dosage is 5μg/kg/day. Physical
      examination and interview, Appel ALS scale and ALS-Functional Rating Scale will be done in
      14, 28 days and 3, 6, 9, 12 months. Electrophysiological examination will be tested per 3
      months. Blood samples will be collected on treat 5, 14, 28 days and 3, 6, 9, 12 months.
    


Intervention name(s): Granulocyte Colony Stimulating Factor; NS
Intervention type(s): Drug; Drug
Intervention description(s): Granulocyte Colony Stimulating Factor,5ug/kg/day iH Qd*5 days,3 months interval for 4 times; NS 1ml iH Qd*5 days, 3 months interval for 4 times
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic Lateral Sclerosis; Granulocyte Colony Stimulating Factor; Randomized Control Trial Study
Comparison of DBS Targets in Obsessive-compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Deep brain stimulation (DBS) has been proposed for severe and resistant obsessive-compulsive
      disorder. This electrical stimulation has been tested on, and shown to be effective at,
      different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the
      efficacies of each target have never been compared directly.

      This protocol aims to do so, with the hypothesis that subthalamic (STN) stimulation will be
      more efficacious.
    

Detailed description: 
      Deep brain stimulation has been proposed for severe and resistant obsessive-compulsive
      disorder (OCD). This electrical stimulation has been tested on, and shown to be effective at,
      different targets (subthalamic nucleus, caudate nucleus & nucleus accumbens). However, the
      efficacies of each target have never been compared directly.

      Therefore, bilateral subthalamic and caudate electrodes will be implanted in severe OCD
      patients. Efficacy of stimulation at the different targets will be assessed using a
      double-blind randomised crossover design.
    

Intervention name(s): Deep brain stimulation
Intervention type(s): Procedure
Intervention description(s): Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Obsessive-Compulsive Disorder; Deep brain stimulation; Subthalamic nucleus; Caudate nucleus; Nucleus accumbens
FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety
      of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled
      ovarian hyperstimulation in a GnRH-antagonist cycle.
    


Intervention name(s): Urofollitrophin; Follitrophin alpha
Intervention type(s): Drug; Drug
Other intervention name(s): human derived follicle stimulation hormone; Recombinant follicle stimulation hormone
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: In vitro fertilization (IVF); Assisted reproduction technologies (ART); GnRH-antagonist; Follicle stimulating hormone (FSH)
Dose Escalation Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Epelsiban Administered in Repeat Doses in Healthy Women Volunteers
Condition: Embryo Transfer
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is designed to assess the safety, tolerability and pharmacokinetics (PK) of
      additional repeat doses of epelsiban in healthy females, and will be the first dosing
      experience of repeat dosing at higher doses in women with this compound.

      This study is a 14 day, randomized, placebo-controlled, double blind (sponsor unblind),
      repeat dose, ascending cohort, dose escalation study in healthy, female volunteers. Upon
      successful completion of the Screening period, a subject will be enrolled in the study. The
      study will be composed of three periods: Screening, Treatment and Follow-up. A subject's
      total time involved in the study will be approximately six weeks.

      Cohorts will be conducted sequentially. Each subject will be enrolled in only one cohort. Ten
      subjects will be enrolled in each cohort and randomized to epelsiban (n=8) or placebo (n=2).
    


Intervention name(s): Epelsiban (GSK557296); Placebo to match GSK557296
Intervention type(s): Drug; Drug
Intervention description(s): White to off-white 0.270 inches x 0.700 inches oblong film coated tablet containing 25 mg or 100 mg epelsiban. To be swallowed whole with water, not to be chewed.; White to off-white 0.270 inches x 0.700 inches oblong film coated Tablet containing placebo. To be swallowed whole with water, not to be chewed.
Intervention MeSH terms: Diketopiperazines
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Safety; Dose Escalation; Repeat Dosing; Epelsiban; Pharmacokinetics; Healthy Women Volunteers; Tolerability; Oxytocin
The Acute Effects of Meals Rich in Saturated or Unsaturated Fatty Acids on Postprandial Lipaemia in Healthy Men
Condition: Cardiovascular Risk Factor
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      Current dietary recommendations suggest that lowering intake of saturated fats or replacing
      it with unsaturated fats will decrease the risk of developing cardiovascular disease. Coconut
      oil has gained popularity in recent years but it contains 90% saturated fat, which has higher
      percentage of saturated fat than butter. To date, only limited studies have determined the
      acute effects of meals containing coconut oil on blood lipids, but findings are inconsistent.
      Therefore, further studies are needed to address this knowledge gap and compare the
      postprandial effects of test meals rich in coconut oil with other sources of saturated fatty
      acids such as butter and unsaturated fatty acids (vegetable oils). A cross-over,
      double-blind, randomised acute postprandial study will be conducted in 15 healthy men.
      Participants will be assigned to consume the test meals rich in saturated or unsaturated
      fatty acids in random order on 3 separate occasions, with 3-4 weeks between each study visit.
      Participants will be provided with breakfast (toast with jam and milkshake, 50g fat) and
      lunch (toast with jam and milkshake, 30g fat). The anthropometric, blood pressure, arterial
      stiffness, and breath samples will be taken for each study visit. Blood samples will be
      collected for the measurement of fasting lipids, glucose, insulin, inflammatory markers,
      whole blood culture as well as blood clotting. Breath samples are collected for the
      measurement of gastric emptying as well as assessment of satiety using questionnaires (100 mm
      visual analogue scale) completed throughout the day. The findings from this study will
      contribute to the evidence base on how consuming meals rich in coconut oil influence the
      level of blood lipids as well as other biomarkers for cardiovascular disease.
    


Intervention name(s): Coconut oil; Butter; Vegetable oil
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 50 g of coconut oil will be added to the test meal for breakfast and 30 g of coconut oil will be added to the test meal for lunch; 50 g of butter will be added to the test meal for breakfast and 30 g of butter will be added to the test meal for lunch; 50 g of vegetable oil will be added to the test meal for breakfast and 30 g of vegetable oil will be added to the test meal for lunch
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Coconut oil; Postprandial lipaemia; Platelet function; Gastric emptying; Appetite
Proleukin and Rapamune in Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I trial in individuals who have been diagnosed with type 1 diabetes within
      the previous 3-48 months. The study is testing whether two immune system modifying drugs are
      safe when used in combination and if they have immune altering effects that indicate they can
      halt the progression of type 1 diabetes progression.
    

Detailed description: 
      At the time of diagnosis with type 1 diabetes, 15-40% of beta cells may remain active and
      healthy in the pancreas, capable of producing insulin the body needs to regulate blood
      glucose levels. Because even small amounts of natural insulin production can decrease the
      long term effects of diabetes, it is essential that these cells are preserved.

      This trial will test whether a combination of the drugs Proleukin (IL-2) and Rapamune
      (sirolimus) may be safely administered to recently diagnosed type 1 diabetes patients and
      whether it causes changes to the immune system that can halt the autoimmune destruction of
      the remaining beta cells. This drug combination has been found to be effective for long-term
      diabetes prevention in mouse models of type 1 diabetes.

      This study is a phase I study for individuals 18-45 years of age who have been diagnosed with
      type 1 diabetes in the past 3-48 months. All participants will be treated with Proleukin
      (administered subcutaneously 3x per week) for 28 days and Rapamune (taken orally, daily) for
      12 weeks. The study will last for 12 months, with additional follow-up of 24 months. The
      majority of study visits occur within the first 6 months. Mixed meal tolerance tests, in
      which participants take a milkshake-like drink and have blood sampled over a 2 or 4-hour
      period, will take place during an initial screening visit and three additional times during
      the first year. All participants will also receive intensive diabetes management designed to
      maintain stable blood glucose levels.
    

Intervention name(s): IL-2; Rapamycin
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous injection at a dose of 4.5x10^6 IU/day, three times weekly for 28 days starting on day 0.; Administered orally, initial daily dose of 2mg. At day 7, dose adjusted to achieve and maintain whole blood trough levels of 5-10 ng/ml.
Other intervention name(s): Proleukin; Rapamune; Sirolimus
Intervention MeSH terms: Sirolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; juvenile diabetes; type 1 diabetes; diabetes mellitus; recent onset; new onset