bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate Safety and Efficacy of an Oral Contraceptive (OC) Preparation Versus Placebo for 6 Treatment Cycles in Women With Moderate Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study were to evaluate the efficacy and safety of drospirenone 3
      mg/ethinyl estradiol 0.02 mg (DRSP/EE) in comparison with placebo in female subjects with
      moderate acne vulgaris during 6 treatment cycles
    


Intervention name(s): YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The study medication was packaged in 28-tablet blister packs. Each subject kit contained 6 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the active treatment group received 24 consecutive days of hormonally active tablets (3mgDRSP/0.02mgEE) followed by 4 consecutive days of inactive tablets. The treatment period was 6 cycles (28 tablets per cycle).; The subjects randomly assigned to the placebo group received 28 inert but identical-appearing, color-matched tablets. The treatment period was 6 cycles (28 tablets per cycle)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moderate Acne Vulgaris; Acne
Local Analgesia to Prevent Pain in Patient Undergoing Removal of the Uterus Through Vaginal Route
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Following a hysterectomy, women tend to experience high levels of pain, and many require
      strong pain killers after the procedure. Ropivacaine is a local anaesthetic drug (injectable
      numbing medication) which works by blocking pain signals. The aim of this study is to find
      out whether injections of ropivacaine during surgery can help provide effective pain relief
      after surgery.Women aged between 45 and 70 who are having a vaginal hysterectomy can
      participate in the trial. Participants are randomly allocated to one of two groups. Those in
      the first group are given injections of ropivacaine at the site of the wound and in the
      peritoneum (space in the body that holds the organs in the abdomen) and those in the second
      group are given injections of a saline fluid in the same places that offers no pain relief
      before the end of their surgery. Participants in both groups are then regularly asked to rate
      their pain levels up to 24 hours after surgery. In addition, the pain killers they receive
      and length of hospital stay are recorded. There is a chance that the participants who receive
      the ropivacaine will benefit from lower pain levels after surgery. There are no notable risks
      of participating.
    

Detailed description: 
      At end of the vaginal hysterectomy operation, the gynecologist will inject the uterosacral,
      cardinal ligaments, adnexal areas and the vaginal edge with 15 ml of either the ropivacaine
      solution or the placebo fluid in each side, then 20 ml will be instilled inside the
      peritoneum. Analgesia will be given on request after operation. Visual analogue score of 0 to
      100 mm will be used to assess the degree of pain, with 0 indicating no pain and 100
      indicating worst pain.
    

Intervention name(s): Ropivacaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): local anesthetic will be given locally at the site of operation to decrease the level of pain after operation; placebo fluid will be given at the site of operation locally
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Apatinib for Esophageal Squamous Cell Cancer After the Failure of Standard Treatment
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      We conduct the phase II clinical trial to further explore the efficacy and safety of Apatinib
      Mesylate in treating recurrent or metastatic esophageal squamous cell carcinoma after the
      failure of conventional treatments. An exploratory molecular marker analysis will be
      performed in order to find out the beneficial population of Apatinib Mesylate.
    

Detailed description: 
      Esophageal cancer is one of the most common malignant tumor in China. In Asian countries,
      esophageal squamous cell carcinoma is the main pathological type of esophageal carcinoma.
      Prognosis of esophageal squamous cell carcinoma is usually poor and surgery is the only
      radical treatment. Cisplatin (DDP, cisplatin), 5 - Fluorouracil (5 - Fluorouracil, 5 - FU)
      and taxane are the most adopted chemotherapy agents, with efficacy rates of 33%-40% as
      first-line treatment for metastatic or recurrent esophageal squamous carcinoma and a median
      overall survival of 6-10 months. New agents were needed. Apatinib Mesylate is a small
      molecule VEGFR tyrosine kinase inhibitor. The anti-tumor mechanism of Apatinib is inhibiting
      angiogenesis in malignancy by inhibiting VEGFR. Apatinib Mesylate was approved by CFDA (China
      Food and Drug Administration) for the treatment of advanced gastric cancer. In the previous
      clinical practice, we observed that part of the patients with esophageal squamous cell
      carcinoma were resistant to conventional treatments benefited from Apatinib Mesylate. Based
      on the research situation mentioned above, we decided to conduct a phase II clinical trial to
      further explore the efficacy and safety of Apatinib Mesylate in treating recurrent or
      metastatic esophageal squamous cell carcinoma after the failure of conventional treatments.
      An exploratory molecular marker analysis will be performed in order to find out the
      beneficial population of Apatinib Mesylate.
    

Intervention name(s): Apatinib Mesylate
Intervention type(s): Drug
Intervention description(s): Patients will receive Apatinib Mesylate at 500mg/times,oral one times daily for 28 days.
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery
Condition: Scheduled Cardiac Surgery; Age Under 85 Years
Study type: Interventional
Phase: Phase 2

Summary: 
      The sternotomy site is the most painful site after cardiac surgery. Local infiltration of
      ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after
      sternotomy significantly reduces pain at rest and during mobilization, reduces opioids
      consumption, decreases postoperative complications, improves patient comfort and satisfaction
      and reduced hospital costs. In this study our hypothesis is to test the efficacity of local
      anesthetic administration via the catheters in the BLS position placed before the surgical
      incision.
    

Detailed description: 
      Goal of the study: Evaluation of the effectiveness of BLS technique on a composite endpoint
      (pain at rest, pain during patient mobilization and opioid consumption).

      Open trial, therapeutic, prospective, monocentric. One group of patients who will benefits
      from the placement of two multihole catheters in BLS position:

        -  The ropivacaine group (40 patients): placement by the surgeon of two catheters in BLS
           position before the surgical incision. Administration of a bolus dose of 10 ml of
           ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine
           2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.

        -  The control group (80 patients) from the two previous studies who underwent standard
           analgesia with PCA morphine.
    

Intervention name(s): Ropivacaine
Intervention type(s): Drug
Intervention description(s): Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter Continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
Intervention MeSH terms: Ropivacaine
Intervention model: Single Group Assignment
Intervention model description: Placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Postoperative analgesia; Sternotomy; Local anesthetics
School Health Center Healthy Adolescent Relationship Program
Condition: Adolescent Relationship Abuse
Study type: Interventional

Summary: 
      This community-partnered participatory study will work within high school health centers
      (SHCs) to test, via a 2-armed cluster randomized controlled trial, a multi-level intervention
      to reduce adolescent relationship abuse (ARA) among adolescents ages 14-19. The goal of this
      study is to examine the effectiveness of the School Health Center Healthy Adolescent
      Relationships Program (SHARP) intervention in SHCs on individual SHC clients, the SHC clinic
      environment, and the schools in which the SHCs are located. Evaluation of the intervention
      will involve random assignment of eight comparable SHCs in the Greater Bay Area of California
      that provide comprehensive health services, to either intervention or control sites.
      Adolescent females and males ages 14-19 seeking care at any of these SHCs (N=1200) will be
      assessed via audio computer-assisted survey instrument (ACASI) at baseline and 16-20 weeks
      follow-up to examine intervention effects on knowledge and self-efficacy regarding ARA, harm
      reduction and ARA-related resources as well as intentions to intervene with peers. For youth
      reporting recent ARA victimization, the investigators will assess for increases in ARA
      disclosure, resource utilization, as well as reduction in ARA victimization.
    


Intervention name(s): SHARP Intervention
Intervention type(s): Behavioral
Intervention description(s): Providers and staff located in high school school health centers (i.e., nurse practitioners, nurses,physicians, health educators, medical assistants) will be trained to address adolescent relationship abuse with school health center clients using knowledge, skills, and resources gained through the SHARP Intervention training. The training includes strategies to help youth recognize adolescent relationship abuse among themselves and their peers, to learn strategies to increase safety (harm reduction), and to utilize adolescent relationship abuse-related resources.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Adolescent; Intervention; Female; Male; Interpersonal Relations; School Health Services; Community-Based Participatory Research; Randomized Controlled Trial; Health Care Provider; Training Program; Harm Reduction; Prevention; Reproductive Coercion; Tech-Based Abuse; Social Environment; Sexual Partners
Irinotecan/Oxaliplatin/5-Fluorouracil/Leucovorin/Cetuximab As First Line Treatment In Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy of FOLOFOXIRI plus Cetuximab combination in young
      patients with good performance status with unresectable metastatic colorectal cancer.
    

Detailed description: 
      The combination of FOLFOXIRI plus cetuximab is reasonable safe regimen especially for
      patients with good performance status. The estimated benefit from the combination is greater
      than the possible risk, especially for the patients who will become resectable after
      treatment. It will be extremely interesting to evaluate the resectability rate of this
      specific group of patient with good performance status and unresectable disease when they are
      treated with all active chemotherapeutic agents and cetuximab
    

Intervention name(s): Irinotecan; Leukovorin; Oxaliplatin; 5-FLUOROURACIL; Cetuximab
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Irinotecan will be administered at a dose of 150mg/m2 as a 30 min IV infusion on day 1; Leukovorin will be administered at a dose of 200mg/m2 as a 2-hour IV infusion on days 2 and 3; Oxaliplatin will be administered on day 2 at the dose of 65mg/m2 as a 2-hours IV; 5-FLUOROURACIL at the dose of 400mg/m2 as IV bolus and then, 600mg/m2 as a 22-hour continuous IV infusion, on days 2 and 3; Cetuximab will be administered at the dose of 500mg/m2 as a 2-hour infusion on day 1 at least one hour before chemotherapy
Other intervention name(s): CPT-11; Campto; LV; LoHP; Eloxatin; 5-FU; Erbitux
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Irinotecan; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal Cancer; Cetuximab; FOLFOXIRI
A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203
Condition: Hypogonadism; Low Testosterone
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the continued effects of Androxal on morning
      testosterone and reproductive status in men with secondary hypogonadism who have completed
      protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim
      (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5
      mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the
      lower dose.
    


Intervention name(s): Androxal (enclomiphene citrate); Testim (topical testosterone)
Intervention type(s): Drug; Drug
Intervention description(s): capsules oral 1x a day
1 year; topical
1 tube
1x a day
1 year
Other intervention name(s): enclomiphene citrate; topical testosterone; exogenous testosterone; testosterone gel
Intervention MeSH terms: Methyltestosterone; Citric Acid; Sodium Citrate; Enclomiphene; Clomiphene; Zuclomiphene; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypogonadism; low testosterone; low T
Bioequivalence Study of Ondansetron Tablets USP 8 mg Under Fed Condition
Condition: Fed
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open Label, balanced, two-treatment, two-period, two-sequence, single
      dose, cross over pivotal study. The purpose of this study is to assess the bioequivalence
      between Test Product and the corresponding Reference Product under fed condition in normal,
      healthy, adult, human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Ondansetron Tablets USP 8 mg of M/s Ipca Laboratories Limited, India and the corresponding
      Reference Product: Zofran® (Ondansetron hydrochloride) 8 mg Tablets of M/s GlaxoSmithKline,
      under fed condition in normal, healthy, adult, human subjects in a randomized crossover
      study.

      The study was conducted with 48 healthy adult subjects. In each study period, a single 8 mg
      dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 11 days including washout period of at
      least 7 days between administrations of study drug in each study period.
    

Intervention name(s): Ondansetron Tablets USP 8 mg; Ondansetron Hydrochloride
Intervention type(s): Drug; Drug
Intervention description(s): 8 mg tablet once a day; 8 mg tablet once a day
Other intervention name(s): Test Product; Zofran®
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cerebral Blood Flow in Single Ventricles Throughout Staged Surgical Reconstruction
Condition: Single Ventricle Defect
MeSH terms: Univentricular Heart
Study type: Observational

Summary: 
      This study seeks to determine cerebral blood flow changes in single ventricle patients during
      staged surgical reconstruction as compared with normal children. Two general groups of single
      ventricle patients will be recruited for this study, corresponding to the two approaches
      used. An aged-match group of healthy subjects will be included as a control.
    

Detailed description: 
      This is a prospective, non-randomized, single center study designed to measure and determine
      the changes in cerebral blood flow in a cohort of single ventricle patients followed across
      all three stages of surgical (Fontan) reconstruction. In addition, cerebral blood flow
      response to hypercarbia will be determined after the first 2 operations as a measure of
      cerebral blood flow reserve and the "intactness" of the cerebral autoregulatory system. MRI
      data from this cohort will be compared with that collected in age-matched healthy children
      and in a cross sectional group of patients who will not necessarily be followed through all
      stages of surgery, but may undergo one or two of the MRI evaluations depending on their stage
      of surgery. Neurological exams and EEGs will be performed. Medical history, cardiac
      catheterization data, where available, will also be collected. Factors such as
      cardiopulmonary bypass time and socioeconomic class will be controlled for.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Single ventricle patients will be recruited from the cohort of patients treated and/or
        followed at The Children's Hospital of Philadelphia in the cardiology program and
        surrounding hospitals/institutions. In specific, patients will be approached to participate
        in the study during clinic visits or visits to the hospital for other reasons. Children for
        the normal control group will be recruited from children who are undergoing clinical MRIs
        at CHOP. A full understanding of all study related procedures and processes will be
        explained to the subject, including all MRI scans, how the MRI scanner works and how the
        proposed research will help medical practice. Children likely to have a normal brain MRI
        will be asked to participate and sign an informed consent form.
      
Keywords: Single ventricle; Hypoplastic Left Heart Syndrome; Congenital heart lesion; Right or left ventricle; Cerebral blood flow; Pulmonary blood flow; Staged Fontan reconstruction; hemi Fontan/bidirectional Glenn stages
ADME Study of [14^C]-Ibrexafungerp in Healthy Male Subjects
Condition: Fungal Disease
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open-label, single center, non-randomized study to evaluate the
      absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled
      Ibrexafungerp following repeat administration in healthy male subjects. All subjects will
      undergo preliminary screening procedures, will remain the clinical unit for approximately 26
      days and will receive radiolabeled Ibrexafungerp, orally for 3 days.
    


Intervention name(s): Ibrexafungerp
Intervention type(s): Drug
Intervention description(s): carbon-14 ([14^C])-Ibrexafungerp
Intervention MeSH terms: Ibrexafungerp
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of Multiple Doses of Lasmiditan in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at how much lasmiditan, study drug, gets into the blood
      stream and how long it takes the body to get rid of it.

      When drugs are taken together, one or all of the drugs used in combination may be affected.
      This study will also evaluate the concentrations in the blood of a probe drug cocktail taken
      alone and in combination with lasmiditan. Information about any side effects that may occur
      will also be collected.

      The study has two parts. Participants will only enroll in one part. This study will last
      about 25 days for group 1 and 22 days for group 2, not including screening. Screening is
      required within 28 days prior to the start of the study.

      This study is for research purposes only and is not intended to treat any medical condition.
    


Intervention name(s): Probe Drug Cocktail; Lasmiditan; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Other intervention name(s): LY573144
Intervention MeSH terms: Lasmiditan
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science