bioihbjkbjnl/mcl2 huggingface dataset:
Investigate the Responsiveness of the Erectile Quality Scale to Vardenafil Flexible Dose vs Placebo in Males With Erectile Dysfunction (ED)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to evaluate in adult men with erectile dysfunction (often called
      impotence), the effect of vardenafil HCl on the quality of their erections. Many men
      experience occasional erectile problems during their lives. The causes of erectile
      dysfunction are varied and may be due to physiological or emotional reasons. This study is
      designed to study the responsiveness of the erection quality scale (EQS) to vardenafil HCl.
      In this study, vardenafil HCl will be compared to placebo. Placebo is a pill which looks like
      the real drug but it is not. It contains no active ingredients.
    


Intervention name(s): Placebo; Levitra (Vardenafil, BAY38-9456)
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo; 5m, 10 mg and 20 mg 1 h prior to sexual intercourse
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erectile Dysfunction; Vardenafil
Impact of Implant Supported Overdenture on Changes of Electromyographic and Brain Activity
Condition: Implant Supported Overdenture
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the effects of a mandibular
      implant-supported overdenture with a mandibular complete denture on electromyographic
      activity, brain activity, and cognitive performance in edentulous patients. Ten patients who
      are entirely edentulous and did not wear dentures will be chosen. To assess brain activity
      and cognitive function, electroencephalograms, the Mini-Mental State Examination (MMSE), and
      electromyographic examinations of the temporalis and masseter muscles will be performed prior
      to complete denture construction, one and three months after complete denture construction,
      and one and three months after implant supported overdenture insertion, respectively.
    


Intervention name(s): Implant supported overdenture
Intervention type(s): Other
Intervention description(s): Implant supported overdenture compared to complete denture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Psychiatric Rehabilitation Approach to Weight Loss
Condition: Schizophrenic Disorders
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The primary aim of the project is to examine the efficacy of the Psychiatric Rehabilitation
      Weight Loss program in reduction of weight and body mass index (BMI.
    

Detailed description: 
      The study involves 144 individuals who will be randomly assigned to the intervention group or
      treatment as usual group(control group). All Participants will undergo baseline assessment,
      assessment at week 12, week 24 and in year from baseline.
    

Intervention name(s): Psychiatric Rehabilitation Approach to Weight Loss
Intervention type(s): Behavioral
Intervention description(s): The use of psychiatric rehabilitation as a way to lose weight
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Papuan Indigenous Model of Male Circumcision
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      The purpose of the study is: AIM 1: To engage Papuan community members to explore
      acceptability, barriers and facilitators for introducing a school-based age and culturally
      appropriate, comprehensive VMMC intervention to reduce HIV incidence in the Papuan
      population. AIM 2: To assess the capacity of the community health system to meet
      international criteria for safe comprehensive VMMC services and to ensure the availability of
      resources and training necessary to meet these criteria in selected clinics. AIM 3: To design
      the PIM of school-based adolescent VMMC based on information collected in Aims 1 and 2 and in
      consultation with a community advisory board, the Ministry of Health and the Ministry of
      Education. AIM 4: To pilot-test the school-based PIM Intervention of VMMC with 400 boys ages
      12-18 years at two HIV high-risk Papuan locations: the Nabire and Jayapura. Primary outcomes
      are the proportion of adolescent males exposed to school-based PIM VMMC educational and
      informational sessions who get circumcised and surgical event safety. Secondary outcomes are
      satisfaction by adolescent males and parents, any sexual activity within 6 weeks after
      circumcision, changes in sexual risk behaviors between base-line and 12 weeks after
      circumcision, and perceptions of providers regarding MC training and implementation, ease of
      device use, and challenges encountered.
    


Intervention name(s): Medical male circumcision using standard surgical technique.
Intervention type(s): Procedure
Intervention description(s): Medical male circumcision using the WHO standard technique followed by examination of wound healing and behavioral risk assessment.
Intervention model: Single Group Assignment
Intervention model description: Observational study of recruitment of young Papuan men who volunteer for medical male circumcision.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV Prevention; Male circumcision; Papua Indonesia
L-BLP25 in Patients With Colorectal Carcinoma After Curative Resection of Hepatic Metastases
Condition: Colon Carcinoma; Rectum Carcinoma
MeSH terms: Carcinoma; Neoplasm Metastasis; Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Comparative evaluation of recurrence-free survival (RFS) time and 3 year overall survival
      (OS) time between the treatment groups (L-BLP25 plus cyclophosphamide versus placebo and
      saline infusion).
    

Detailed description: 
      This trial is designed for patients with metastatic colorectal carcinoma (CRC), who have
      undergone a complete resection of their primary tumor and recent resection of their liver
      metastases (R0 or R1) with curative intent. No generally accepted standard care is available
      following curative-intent resection of hepatic metastases in colorectal cancer patients.
      L-BLP25 is a cancer vaccine that targets MUC1, a well known tumor-associated antigen.
      Recently, it has been shown that MUC1 is associated with cellular transformation as
      demonstrated by tumorigenicity and can confer resistance to genotoxic agents. High levels of
      MUC1 cell surface expression, reported immunosuppressive activities of its released
      ectodomain, and anti-adhesive properties all contribute to the ability of the MUC1 antigen to
      protect and promote tumor cell growth and survival, and make MUC1 an attractive target for
      cancer immunotherapy.

      Based on these results, L BLP25 may have potential as adjuvant therapy after curative
      resection of hepatic metastases in colorectal cancer patients.
    

Intervention name(s): L-BLP25; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Treatment: 930µg per treatment once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.; Treatment: Placebo 930µg per treatment, once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.
Other intervention name(s): MUC1-antibody
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Colon carcinoma; Rectum carcinoma; Liver metastases
Plerixafor Plus Granulocyte Colony-Stimulating Factor For Mobilization And Collection Of Peripheral Hematopoietic Stem Cells In Japanese Participants With Non-Hodgkin Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To determine if non-Hodgkin Lymphoma (NHL) participants mobilized with granulocyte
      colony-stimulating factor (G-CSF) plus plerixafor 240 μg/kg are more likely to achieve a
      target number of greater than or equal to 5 x 10^6 cluster differential (CD) 34+ cells/kg in
      4 or fewer days of apheresis than NHL participants mobilized with G-CSF alone.

      Secondary Objectives:

        -  To evaluate the safety of G-CSF plus plerixafor arm compared to G-CSF arm in NHL
           participants.

        -  To compare the 2 treatment arms with respect to the number of participants who achieved
           a minimum of 2 x 10^6 CD34+ cells/kg in 4 or fewer days of apheresis.

        -  To compare the 2 treatment arms with respect to the number of days of apheresis required
           to reach the target of greater than or equal to 5 x 10^6 CD34+ cells/kg.
    

Detailed description: 
      Total study duration for a participant can be approximately up to 68 days.
    

Intervention name(s): plerixafor GZ316455; Filgrastim
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:vial Route of administration: subcutaneous injection; Pharmaceutical form:vial Route of administration: subcutaneous injection
Other intervention name(s): Mozobil
Intervention MeSH terms: Plerixafor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohn's
      disease of the small bowel.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, placebo controlled, multicenter study. Patients are
      randomized to receive either oral 4-aminosalicylic acid (4-ASA) or placebo twice a day for 12
      weeks. After 12 weeks patients who improved with 4-ASA and those who received placebo are
      given the option of receiving 4-ASA for an additional year.

      Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are
      followed every 3 months for 1 year. Patients who were randomized to receive placebo and begin
      4-ASA therapy after 12 weeks are followed monthly for 3 months, then every 3 months for 1
      year.

      Completion date provided represents the completion date of the grant per OOPD records
    

Intervention name(s): -aminosalicylic acid
Intervention type(s): Drug
Intervention MeSH terms: Aminosalicylic Acid
Allocation: Randomized
Primary purpose: Treatment
Keywords: Crohn's disease; gastrointestinal disorders; rare disease
ALX-0171 Phase I Study, Evaluating Single Ascending Dose and Multiple Dose in Healthy Male Volunteers
Condition: RSV Infection
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      ALX-0171 is a Nanobody directed against the human respiratory syncytial virus (RSV). The
      purpose of this first-in-man study is to determine the safety, tolerability and
      pharmacokinetics (PK) of ALX-0171 after single and multiple pulmonary administrations in
      healthy male volunteers.
    


Intervention name(s): ALX-0171; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Single or multiple ascending doses (2.1-210 mg), administered via pulmonary inhalation. Multiple dosing will consist of twice daily dosing on 5 consecutive days.; Single or multiple doses, administered via pulmonary inhalation. Multiple dosing will consist of twice daily dosing on 5 consecutive days.
Intervention MeSH terms: Gontivimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study of Ultrasonography With Elastography in Skin Neoplasms
Condition: Benign and Malignant Skin Neoplasms
MeSH terms: Neoplasms; Skin Neoplasms
Study type: Observational

Summary: 
      This study will look at high frequency ultrasound as a medical imaging modality and apply it
      to skin lesions. Elastography is an ultrasonic method of looking at the hardness of an area.
      We will use this to try and differentiate between benign and cancerous skin lesions.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        General dermatologic population from suburban referral clinic.
      
Biospecimen description: 
      Skin biopsies of lesions imaged with ultrasound are processed for routine histology and
      retained.
    
Keywords: Elastography; Cutaneous; Imaging
The Stanford Parkinson's Disease Plasma Study
Condition: Parkinson Disease(PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate that young plasma infusions can be performed
      safely in patients with Parkinson's Disease (PD). Secondary outcomes will include behavioral
      and laboratory data that will support the next study that will inquire whether young plasma
      infusions improve or slow the progression of cognitive, mood and/or motor impairment and rate
      markers of the disease.
    

Detailed description: 
      Parkinson's disease (PD) is a neurodegenerative disease that affects over 1.6 million people
      in the United States and whose incidence increases with age, affecting over 1% of people over
      the age of 65. The neuropathological processes involved in PD are widespread throughout the
      brain, and are reflected in a constellation of motor, cognitive, mood and other non-motor
      symptoms. Treatments to date have largely focused on dopamine replacement strategies or deep
      brain stimulation, both symptomatic treatments.

      As neurodegenerative diseases progress, there are major changes throughout the body and
      brain. These changes are transmitted in the body via the circulatory system between organs,
      tissues and cells. Recent findings from multiple laboratories have shown that infusions of
      young plasma into aging rodents can have beneficial effects on cognitive functions. This
      suggests that the circulating components of plasma can improve cognitive and disease-relevant
      symptoms. This has motivated the field to treat multiple disorders with blood products and
      their constituent active components.

      The established safety of blood transfusions allows the investigators to test whether
      infusions of young plasma can ease the neurological symptoms in human subjects with
      neurodegenerative diseases. A related study of plasma infusions has already been completed at
      Stanford in patients with Alzheimer's disease (ClinicalTrials.gov identifier NCT02256306).

      The investigator proposes to test the safety and efficacy of transfusing young plasma into PD
      participants, in order to establish its effects on motor and cognitive functions in
      participants in a Phase 1 study. The successful completion of this study will inform the
      design of future, larger and multicenter studies with the goal to determine whether infusions
      of young plasma can ameliorate the neurodegenerative symptoms and underlying pathophysiology
      in Parkinson's disease.
    

Intervention name(s): Infusions of young plasma
Intervention type(s): Drug
Intervention description(s): Participants will receive four twice- weekly infusions of 1 unit young plasma (male, ages between 18-25)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Young Male Plasma
Ambulatory Continuous Adductor Canal Block to Facilitate Same Day Discharge Following Total Knee Arthroplasty: A Pilot Study
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Patients scheduled to undergo total knee arthroplasty will receive motor sparing knee blocks
      with continuous adductor canal block along with multimodal analgesia started pre-operatively
      and continued into the postoperative period. The study will evaluate the feasibility of home
      discharge within the first 24 hours following total knee arthroplasty. We will also evaluate
      the pain scores in the first 5 days following the surgery, causes of delayed discharge and
      any adverse events.
    


Intervention name(s): Adductor canal block
Intervention type(s): Procedure
Intervention description(s): All patients will recieve fast tracking with reduced fasting times, multimodal analgesia and adductor canal block
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Ambulatory home regional; adductor canal block; Postoperative pain; total knee arthroplasty; Home regional; Fast track arthroplasty
Almorexant (ACT 078573) in Adult Subjects With Chronic Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      A polysomnography study to evaluate the effect, safety and tolerability of oral
      administration of almorexant (ACT 078573) in adult subjects with primary insomnia.
    


Intervention name(s): almorexant; almorexant; Placebo; zolpidem
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 100 mg almorexant tablets and 1 placebo matching over-encapsulated zolpidem; 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem; 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem; 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sleeplessness; orexin receptor antagonist; almorexant; insomnia
Bioequivalency Study of Exemestane 25 mg Tablet Under Fed Conditions
Condition: Breast Cancer
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Exemestane 25 mg tablet under
      fed conditions.
    


Intervention name(s): exemestane
Intervention type(s): Drug
Intervention description(s): 25 mg tablet
Other intervention name(s): AROMASIN
Intervention MeSH terms: Exemestane
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Uremic Toxin Removal and Hemodynamics in Long-hour Hemodialysis and Hemodiafiltration
Condition: Uremic Toxins; Haemodynamic Stability
Study type: Interventional

Summary: 
      Rationale: The mortality of end-stage renal disease (ESRD) patients on dialysis remains high.
      This may at least be partly due to the insufficient removal of (especially protein-bound)
      uremic toxins which have been associated with cardiovascular morbidity and mortality. It is
      unknown whether the combination of long-hour haemodialysis (HD) with convection increases the
      removal of these toxins. Long-hour HD and long-hour haemodiafiltration (HDF) may also improve
      haemodynamic stability which is an important factor in treatment quality. The investigators
      aim to study the removal of uremic toxins in long-hour HD and HDF and to compare the
      haemodynamics between 4-hour and 8-hour HD and HDF.

      Objectives: The primary aim is to study the removal of (especially protein-bound) uremic
      toxins in 4-hour and 8-hour HD and HDF. A secondary aim is to compare the haemodynamic
      response between 4-hour and 8-hour HD and HDF.
    


Intervention name(s): 4-hour HD, 4-hour HDF, 8-hour HD and 8-hour HDF
Intervention type(s): Other
Intervention description(s): Prevalent conventional HD (CHD) patients (dialysing 3 days a week during 4 hours per dialysis session) will undergo, in random order, a mid-week 4-hour HD session, a mid-week 4-hour HDF session, a mid-week 8-hour HD session, and a mid-week 8-hour HDF session with a 2-week interval between every session to assess the influence of treatment duration and of convection on the removal of uremic toxins and on the haemodynamic responses and autonomic nervous regulation. In between the study dialysis sessions these patients will receive routine CHD treatments.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 2 Study of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety, efficacy (dose response) and pharmacokinetics of 0.3% and 1%
      OPA-15406 when applied twice daily for 4 weeks in pediatric patients with atopic dermatitis.
    


Intervention name(s): OPA-15406; Placebos
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's Disease
Condition: Idiopathic Parkinson's Disease; Parkinson's Disease; Basal Ganglia Disease; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Nervous System Diseases; Neurodegenerative Diseases; Parkinsonian Disorders
MeSH terms: Parkinson Disease; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Brain Diseases; Central Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety and efficacy of AADC gene transfer in participants with Parkinson's disease.
    

Detailed description: 
      Parkinson's disease (PD) is a neurodegenerative disorder involving loss of dopamine producing
      neurons located in the striatum. Levodopa is the primary treatment used to treat Parkinson's
      disease, which converts to dopamine by the enzyme (protein) Aromatic L-Amino Acid
      Decarboxylase (AADC). As PD progresses, the amount of AADC levels in the brain decreases, and
      in turn, reduces the amount of dopamine that is produced with each dose of levodopa.

      The primary objective of this study is to evaluate the safety of increasing AADC levels, via
      gene delivery. The investigational drug, termed VY-AADC-01, will be injected directly into
      the striatum during a neurosurgical procedure that is performed with real-time MRI imaging to
      monitor delivery.

      Participants will continue to take their Parkinson medications, including levodopa while
      participating in this study.

      The safety and potential clinical responses to VY-AADC-01 will be assessed by repeated
      clinical evaluations of Parkinson's disease, treatment review phone calls, cognitive tests,
      laboratory blood tests, patient reported outcomes scales, patient diaries, collection of
      adverse events, and neuro-imaging. Clinical evaluations will be performed over a 3 year
      follow-up period.
    

Intervention name(s): VY-AADC01
Intervention type(s): Drug
Intervention description(s): Single dose, neurosurgically infused, bilaterally into the striatum.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gene Therapy; PD; Parkinson's Disease; Aromatic L- Amino Acid Decarboxylase; AADC; AAV2-AADC; AAV2; Viral Vector; Gene Transfer; MRI; PET; VY-AADC01