bioihbjkbjnl/mcl2 huggingface dataset:
Dydrogesterone Versus Intravaginal Progesterone in the Luteal Phase Support
Condition: Luteal Phase Defect
Study type: Interventional

Summary: 
      The purpose of this study is to compare efficacy and tolerability of the dydrogesterone and
      the vaginal progesterone, used for luteal phase support.

      (Initial start date was January 2009 but not for patients' recruitment only for paper work,
      documents, team organization, statistical pre-work actions and to gain the official approval
      of Institutional Review Board. The recruitment started in October 2010 and continued until
      October 2013.)
    

Detailed description: 
      The use of gonadotropin-releasing hormone (GnRH) agonists in the ovarian stimulation, which
      prevents a premature surge of luteal hormone (LH), ultimately leads to suppression of the
      pituitary gland and high levels of estrogen observed during induced cycles result in
      inhibiting effect on the implantation of human embryos.

      The luteal support in in-vitro-fertilization (IVF) cycles can be prolonged using human
      chorion gonadotropin(hCG) and/or progesterone.

      Since it has been noted that the use of hCG was related with higher risks of the onset of
      ovarian hyperstimulation syndrome (OHSS), progesterone is nowadays a product of choice in
      luteal support.

      Currently vaginal progesterone is widely used, since the classic oral progesterone results in
      low bioavailability and lower pregnancy rate and the intramuscular progesterone (IM-P) daily
      injections are painful and may cause abscesses, inflammatory reactions and local soreness.

      However, standard protocol for luteal phase support has not been established (i.e. optimal
      dosage, route or duration).

      Dydrogesterone is a retroprogesterone with good oral bioavailability. Oral administration is
      clear advantage, due to expected higher patient compliance and better tolerability than
      currently used vaginal or IM-P.

      We hypothesize that dydrogesterone has the same efficacy as vaginal progesterone but better
      tolerability due to less side effects.
    

Intervention name(s): Oral dydrogesterone; Crinone 8% gel
Intervention type(s): Drug; Drug
Intervention description(s): oral-2x10mg; vaginal-1x90mg
Other intervention name(s): Duphastone (Solvay Pharmaceuticals); Crinone 8% gel (Fleet Laboratories Ltd., Watford, UK)
Intervention MeSH terms: Dydrogesterone; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IVF; luteal phase support; oral progesterone; vaginal progesterone; pregnancy rate; safety; tolerability
Side Effects of Anti-PD-(L)-1 and Anti CTLA-A4 in the Non Small Cells Lung Cancer
Condition: Carcinoma, Non-Small-Cell Lung; Drug-Related Side Effects and Adverse Reactions
MeSH terms: Carcinoma, Non-Small-Cell Lung; Drug-Related Side Effects and Adverse Reactions
Study type: Observational [Patient Registry]

Summary: 
      The immune-related adverse events (irAEs) linked to the important activation of the immune
      system by new immunotherapy treatments in patients affected by Non-small-cell lung carcinoma
      (NSCLC) have not received a lot of systematic study or been monitored over time outside of
      clinical trials.

      This study aims to verify, on the basis of the data collected in a prospective and
      retrospective manner, that the side-effects due of anti-PD-(L)-1 or anti-CTLA-4 treatments
      observed in the target population of the controlled clinical trials are the same as in the
      general clinical population.
    


Intervention name(s): Consultation of the patient's medical files at the hospital
Intervention type(s): Other
Intervention description(s): Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Cliniques Universitaires Saint-Luc's patients with NSCLC eligible and treated with
        immunotherapy.
      
Keywords: Immunotherapy; Anti-PD-(L)-1; Anti-CTLA-4
An Extension Study to Further Evaluate the Safety, Tolerability of GBT440 in Patients With Sickle Cell Disease Who Participated in the Study GBT440-001
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open label, single arm study which enrolled 5 subjects with SCD who previously
      participated in the GBT440-001 study (NCT02285088).
    

Detailed description: 
      This is an open label, single arm study which enrolled 5 subjects with SCD who previously
      participated in the GBT440-001 study (NCT02285088).

      Dosing of study drug was 2 to 6 months, depending on subject's dose assignment in the last
      administration of study drug in GBT440-001 (NCT02285088).

      The primary objective of the study was to evaluate the safety and tolerability of up to a
      total of 6 months dosing of subjects with SCD who participated in the GBT440-001 study
      (NCT02285088).
    

Intervention name(s): GBT440
Intervention type(s): Drug
Intervention description(s): Oral drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Water Oxygenation and Brain Activity
Condition: Muscle Damage
Study type: Interventional

Summary: 
      The primary purpose of this interventional, placebo controlled, crossover, double blind,
      basic science exploratory study is to investigate whether there is a difference in brain
      electrophysiological oscillatory activity in healthy adults before and after oral consumption
      of water containing very small bubbles of oxygen (electrokinetically modified water).
    


Intervention name(s): Control Unmodified Placebo Water; Electrokinetically modified water (EMW); Electrokinetically modified water (EMW); Control Unmodified Placebo Water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Other intervention name(s): Reliant Recovery Water
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: strenuous exercise; muscle soreness
Psychostimulants for Fatigue in Prostate Cancer
Condition: Fatigue; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      Fatigue is one of the most common symptoms of prostate cancer. Fatigue is a lack of energy
      that makes it harder to do the things you normally do every day. Some symptoms of fatigue
      are:

        -  feeling tired and/or weak;

        -  having less interest in activities;

        -  having trouble concentrating;

        -  feeling "down";

        -  feeling exhausted for no clear reason.

      There are not many drugs that are helpful in treating fatigue. However, one group of
      medications does seem to be useful. In this study, we, the investigators at Memorial
      Sloan-Kettering Cancer Center, will be using a psychostimulant called Ritalin. The aim of
      this study is to see if this drug is helpful in treating fatigue in prostate cancer. We are
      also studying the side effects of this medication.
    

Detailed description: 
      This study is open to men who have prostate cancer and report feeling fatigue. We will
      examine the impact of psychostimulant treatment on depressive symptom severity,
      neuropsychological test performance, and overall quality of life, as well as compare the
      frequency and severity of treatment associated adverse side effects. We will be conducting a
      six-week, randomized, double-blind, placebo-controlled, parallel design trial, evaluating the
      relative benefits and risks of methylphenidate, (a psychostimulant medication). Medication
      will be given in once or twice daily dosages (at 8 am and noon) and titrated by one capsule
      every 2-3 days as needed to treat fatigue and as tolerated. Patients will be examined
      regularly for safety. We will monitor vital signs and response to the medication. This study
      will be the first of its kind to evaluate a pharmacologic intervention for fatigue in cancer
      patients that utilizes a novel psychotropic agent (psychostimulant), and assesses outcome
      with measures of fatigue, as well as side effects, psychological distress, depression and
      overall quality of life.

      Objectives: To study the efficacy of methylphenidate vs. placebo in the treatment of fatigue
      in ambulatory men with prostate cancer.

      To study the frequency and severity of adverse side effects associated with this
      psychostimulant drug.

      To study the effects of psychostimulant treatment for fatigue on related domains of
      psychosocial function and quality of life.
    

Intervention name(s): Ritalin
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Bioequivalence Study for Desloratadine OD Tablets 5 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, randomised, single dose, 2-way crossover, comparative bioequivalence
      study.
    

Detailed description: 
      The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's
      Laboratories Ltd., India, desloratadine ODT 5 mg and Schering Corporation, U.S.A.(Clarinex® 5
      mg), desloratadine ODT 5 mg under fasting conditions. The treatment phases were separated by
      a washout period of 14 days. 38 subjects were dosed and were enrolled in the study; 35 of
      these enrolled subjects completed the study.
    

Intervention name(s): Desloratadine
Intervention type(s): Drug
Intervention description(s): Desloratadine ODT 5 mg
Other intervention name(s): Clarinex ODT 5 mg
Intervention MeSH terms: Desloratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Desloratadine; crossover
CKD-828 Drug Interaction Study (Telmisartan)
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetic drug interaction and safety of
      Telmisartan between free combination of Telmisartan and S-amlodipine and Telmisartan
      monotherapy.
    


Intervention name(s): Telmisartan 80mg, S-amlodipine 5mg; Telmisartan 80mg
Intervention type(s): Drug; Drug
Intervention description(s): Telmisartan 80mg and S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out (19 days); Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days)
Other intervention name(s): Micardis 80mg, Anydipine S 5mg; Micardis 80mg
Intervention MeSH terms: Amlodipine; Telmisartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Topiramate-Phentermine Combinations for Cocaine Dependence
Condition: Cocaine Use Disorder
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®),
      alone and in combination, on the reinforcing, subjective and physiological effects of
      cocaine.
    


Intervention name(s): Cocaine; Placebo; Phentermine; Topiramate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.; The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.; The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.; The pharmacodynamic effects of chronic topiramate will be determined.
Other intervention name(s): Adipex®; Topamax®
Intervention MeSH terms: Topiramate; Phentermine; Cocaine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Cocaine; Pharmacotherapy; Phentermine; Topiramate; Self-Administration
A Study of Intranasal Budesonide Aqueous Spray for Treatment of Rhinitis During Periods of High Airborne Pollution
Condition: Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to assess the effectiveness of intranasal budesonide
      aqueous spray 256 microgram (mcg)/day for treatment of rhinitis symptoms during times of high
      airborne pollution.
    


Intervention name(s): Budesonide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will self-administer 2 nasal sprays of Budesonide (64 mcg/spray) once daily up to 10 +\- 3 Days.; Participants will self-administer 2 nasal sprays of matching placebo once daily up to 10 +\- 3 Days.
Other intervention name(s): RHINOCORT
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Airborne pollution; Rhinitis; Budesonide
Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions
Condition: Obesity; Type 2 Diabetes
MeSH terms: Obesity; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to
      placebo in treatment of obesity in an adult population with obesity related co-morbid
      conditions.
    


Intervention name(s): VI-0521; VI-0521; VI-0521
Intervention type(s): Drug; Drug; Drug
Intervention description(s): phentermine 15 mg and topiramate 92 mg, po once daily; phentermine 7.5 mg and topiramate 46 mg, po once daily; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity, Type 2 diabetes
Facilitation and Barriers to Breastfeeding in the NICU
Condition: Breastfeeding; Prematurity
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      To date, there is a paucity of research focusing on maternal breastfeeding goals, how these
      goals may change after an unexpected event such as a preterm birth, and how mothers of ill
      and preterm infants define breastfeeding success. No studies were identified that focused
      exclusively on the breastfeeding goals of mothers of hospitalized preterm infants

      The purpose of this study is to answer the following research questions: 1) What are the
      breastfeeding goals of mothers with preterm infants in the NICU? and 2) What are mothers'
      perceptions of facilitators and barriers to meeting their breastfeeding goals in the NICU?
    

Detailed description: 
      As the objective of this study is to describe the breastfeeding goals of mothers and their
      perceptions of breastfeeding support in the NICU, this study will follow a descriptive,
      qualitative design. Mothers of preterm newborns in the Royal Victoria Hospital will
      participate in a semi-structured interview about their breastfeeding goals and what they
      perceived to be facilitators and barriers to achieving their intended goals. During the
      interviews, the mothers will be asked a set of socio-demographic questions, open-ended
      questions about their breastfeeding goals, and open-ended questions about their perceptions
      of barriers and facilitators to meeting these goals in the NICU Participants may also receive
      one follow-up phone call to clarify their responses to the questions or to validate the
      information obtained from the interview.
    

Time perspective: Prospective
Keywords: Breastfeeding premature infants
Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation
Condition: Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate the safety and feasibility of the Impella
      2.5 Circulatory Support System for use during mapping and ablation of ventricular tachycardia
      in the setting of Ventricular dysfunction.
    

Detailed description: 
      The Impella 2.5 is a percutaneous heart pump that will be used to provide partial circulatory
      support -. The Impella 2.5 is approved by the US Food and Drug Administration and is being
      tested to see if it helps keep the patient's blood pressure stable during the cardiac
      ablation procedure. The Impella 2.5 Circulatory Support System works by placing a small pump
      into the left pumping chamber of the heart which will then help the heart circulate blood
      throughout the body. The Impella 2.5 Circulatory Support system will be removed once the
      heart no longer needs help with the pumping action which can be at any time from just after
      the completion of the heart procedure up to several days post procedure as determined by
      physician.
    

Intervention name(s): Circulatory Support System
Intervention type(s): Device
Intervention description(s): Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects
Other intervention name(s): Impella 2.5 Circulatory Support system insertion
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Ventricular Tachycardia; Radio Frequency Ablation; Percutaneous Left Ventricular Assist Device; Hemodynamic Management; Interventional Cardiac Procedure; Mechanical Cardiac Assistance; Intra-Aortic Balloon Pump; Coronary Intervention; Impella 2.5; Circulation Support system
Evaluation of Different Interfaces for Noninvasive Positive Pressure Ventilation (NPPV)
Condition: Respiratory Failure; Healthy
MeSH terms: Respiratory Insufficiency
Study type: Observational

Summary: 
      In this study the investigators aimed to study the ventilatory performance of different
      interfaces during NPPV delivering.
    

Detailed description: 
      We will test the ventilatory performance in term of ventilatory pattern, muscle effort and
      gas exchange of different interfaces for NPPV.
    

Intervention name(s): Helmet
Intervention type(s): Device
Intervention description(s): Evaluation of different interfaces for NPPV
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy subjects
Quality Control of CE-Certified Phonak Hearing Aids - 2018_28
Condition: Hearing Loss; Sensorineural Hearing Loss
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      Phonak Hearing Systems pass through different development and study stages. At an early
      stage, feasibility studies are conducted to investigate new algorithms, features and
      functions in an isolated manner. If the benefit is proven, their performance is then
      investigated regarding interdependency between all available algorithms, features and
      functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a
      result, they get optimized. Afterwards, and prior to product launch, the Phonak Hearing
      Systems undergo a final quality control in terms of clinical trials. This is a pre-validation
      study, investigating optimized algorithms, features, functions and wearing comfort. This will
      be a clinical investigation which will be conducted mono centric at Sonova AG Headquarters
      based in Stäfa (Switzerland).
    

Detailed description: 
      In this study a comparison with two CE-labeled Phonak Receiver-in-the-canal (RIC) devices is
      done. The experimental device and the active comparator will be compared regarding Sound
      Quality perception and speech intelligibility in Quiet and in Noise. The experimental device
      contains direct connectivity functionality which will be investigated in terms of streamed
      Audio quality, streaming stability and Usability preferences of functions and Features which
      are related to direct connectivity. The active comparator device does not contain direct
      streaming functionality. This will be a clinical investigation which will be conducted mono
      centric at Sonova AG Headquarters based in Stäfa (Switzerland).
    

Intervention name(s): Successor of Phonak Audéo B90; Phonak Audéo B90
Intervention type(s): Device; Device
Intervention description(s): Successor of the most recent Receiver in the canal (RIC) Hearing aid form Phonak which will be fitted to the participants individual Hearing loss.; The Phonak Audéo B90 is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other