bioihbjkbjnl/mcl2 huggingface dataset:
The Study of Polycystic Ovary Syndrome(PCOS) With Gene and Questionnaire
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      Polycystic ovary syndrome (PCOS) is an extremely common disorder in women of reproductive
      age. Diagnosis of PCOS is principally based on clinical and physical findings. Diagnostic
      criteria and PCOS definitions used by clinicians and researchers are almost as heterogeneous
      as the syndrome. This first part of study is determine whether genetic polymorphisms
      influence hormonal and metabolic characteristics in Taiwanese patients with PCOS and
      controls. Furthermore, women with PCOS were reported with high risk of cardiovascular
      disease, the investigators planned to calculate the difference of carotid intima-media
      thickness (IMT) and B-type natriuretic peptide (BNP) between women with PCOS and normal
      control to determine the premature atherosclerosis of women with PCOS.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Polycystic Ovary Syndrome(PCOS)
Arab American Women's Health Study
Condition: Mental Health Wellness 1
Study type: Interventional

Summary: 
      This study evaluates how Arab American women's cultural values and sexual health are related
      to their physical and emotional health. The study will also examine whether engaging in a
      sexual health interview affects women's physical and emotional health.
    

Detailed description: 
      Sexuality is an important aspect of health, in part because emotional conflicts over
      sexuality as well as unwanted sexual experiences can impact physical and psychological
      health; yet no studies have examined sexual health among Arab American women in the U.S.
      These women face the task of negotiating their heritage culture and the American culture in
      which they reside. This may result in bicultural identity conflict for some women as they try
      to negotiate these two identities, which may have implications for sexuality and sexual
      health due to the two cultures' disparate views on sexuality. Confidential discussion of
      these sensitive topics with a knowledgeable interviewer may yield beneficial effects.

      The overall goal of the current study is to fill the gap in the literature on Arab American
      sexual health by examining how sexual health is related to physical and psychological health.
      This will be accomplished using both: a) correlational findings about sexual, physical, and
      psychological health from information gathered through self-report questionnaires and a
      60-minute women's health interview; and b) an experimental test of the effects of the women's
      health interview on physical and psychological health. A sample of young adult Arab American
      women will be assessed at baseline via questionnaires for various constructs (sexual
      attitudes, cultural and religious identity, and physical and mental health), and then
      randomized to either an immediate or delayed health interview, with a 5-week follow-up
      reassessment.

      It is hypothesized that lower sexual well-being, negative sexual self-schemas, and unwanted
      sexual experiences will correlate with more somatic and psychological health symptoms and
      lower satisfaction with life. It is also hypothesized that participants who have the
      immediate interview will report greater reduction in somatic and psychological symptoms and a
      greater willingness to discuss sexual health with medical providers compared to participants
      who are not interviewed (i.e., have a delayed interview after follow-up assessment).
    

Intervention name(s): Immediate interview
Intervention type(s): Behavioral
Intervention description(s): A women's health interview that obtains information about physical, mental, and sexual health, particularly relatively private sexual health-related attitudes and experiences, as well as conflicts and stress related to sexuality.
Other intervention name(s): Women's Health Interview
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: sexual health
Bioequivalence Study of Neurogabin-M (Gabapentin 400 mg) Capsule With Parketin (Gabapentin 400 mg) Capsules
Condition: Healthy Volunteers; Bioequivalence Study
Study type: Interventional

Summary: 
      This is a single-dose, two-periods, two-sequence, two-way crossover, single oral dose
      bioequivalence study.
    

Detailed description: 
      This is an Open Label, Randomized, Single Dose, Two Way Cross over, Two Period, Two
      Treatment, Two Sequence Bioequivalence Study to compare the rate and extent of absorption of
      test drug Neurogabin-M 400 mg, Capsule with reference drug Parketin 400 mg Capsules in
      healthy adult subjects, under fasting conditions.

      The study will be comprised of two Periods, I and II, each consisting of 47 hours, 11 hours
      before and 36 hours after the drug administration. All subjects will be divided into two
      groups of 12 subjects in each group. One group will be treated with the test drug (T) and the
      other one with reference drug (R) in Period I. After the wash-out period of 7 days, the same
      will receive the alternate treatment (RT) in Period II.

      Blood samples at 0 hr (before drug administration) ,1.0, 1.5 , 2.0, 2.5, 3.0, 3.5, 4.0, 5.0,
      6.0, 8.0, 10.0, 12.0, 14.0, 24.0, 28.0, & 36.0 hrs will be taken in both periods for
      quantification of drug in plasma.

      All subjects will be monitored clinically for health status throughout during the periods of
      study and vital signs will be measured at time of check in and 1, 2, 4, 6, 8, 11, 24 and 36th
      hours after drug administration. ECG will be measured at time of screening in the best
      interest of subject safety and well being.
    

Intervention name(s): Neurogabin (Gabapentin) 400 mg capsule; Parketin (Gabapentin) 400 mg capsule
Intervention type(s): Drug; Drug
Intervention description(s): All the subjects will receive a single dose of one capsule of either the Test Drug (Neurogabin 400 mg capsule) or Reference Drug (Parketin 400 mg capsule) in one period. if they receive Test in one period, they will alternatively receive Reference drug in the second period.; All the subjects will receive a single dose of one capsule of either the Test Drug (Neurogabin 400 mg capsule) or Reference Drug (Parketin 400 mg capsule) in one period. if they receive Test in one period, they will alternatively receive Reference drug in the second period.
Other intervention name(s): Gabapentin 400 mg; Gabapentin 400 mg
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence Study
Progesterone Serum Levels in Subfertile Female Patients Undergoing in Vitro Fertilisation (IVF)
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is aimed to demonstrate that highly purified Menotrophin produces significant
      lower progesterone serum levels during the follicular phase in comparison to Follitropin
      alpha in the treatment of subfertile females undergoing an in vitro fertilisation (IVF) and
      to investigate if the progesterone serum levels might be a useful predictor for the success
      rate of the ongoing pregnancy rates
    


Intervention name(s): Menotrophin; Follitrophin alpha; Cetrorelix; Choriongonadotropin; Progesterone
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met.; Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met.; Participants self-inject subcutaneously Cetrorelix in the morning at a daily dose of 0.25 mg/day from Day 5 of gonadotrophin administration on and continue throughout the period of gonadotrophin treatment up to day 12 as a maximum. The last dose of Cetrorelix is given on the day of ovulation induction.; 10,000 IU administered by the Investigator or designated personnel in the evening of the day on which the hCG criterion is met (no later than Day 13). The criterion for hCG administration is three follicles >+17 mm diameter as shown by pelvic ultrasound examination.; Vaginal gel progesterone is used once daily at a dose of 90 mg for a period of 30 days starting on the day of oocyte retrieval (approximately Day 14).
Other intervention name(s): Menogon® HP; Gonal-f®; Cetrotide®; GnRH antagonist; Brevactid®; human chorionic gonadotropin (hCG); Crinone®; intravaginal progesterone
Intervention MeSH terms: Chorionic Gonadotropin; Cetrorelix; Menotropins; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Endoscopic Sphincterotomy With Needle Knife Papillotome in Patients of Ampullary Impacted Stone
Condition: Choledocholithiasis; Endoscopy
MeSH terms: Choledocholithiasis
Study type: Observational

Summary: 
      Using a needle knife papillotome by an experienced endoscopist, endoscopic sphincterotomies
      were performed in difficult cannulation cases. In a prospectively collected database, we
      investigate the complications of those with ampullary impacted stone.
    

Detailed description: 
      The endoscopic sphincterotomy with needle knife papillotome is a well-established advanced
      endoscopic technique in difficult cannulation cases. Choledocholithiasis impacted at the
      ampulla of Vater is occasionally seen. Inflammed surrounding mucosa frequently accompanies.
      Whether sphincterotomy with a needle knife increases the bleeding complications is to be
      elucidated in this study.
    

Observational model: Defined Population
Time perspective: Other
Keywords: Sphincterotomy; needle knife; hemorrhage; complication
Vascular Health and Exercise Performance of Overweight Children
Condition: Patient Compliance
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to assess exercise performance in 20 healthy children 10-19
      years of age with a body mass index greater than 85th percentile and to evaluate the effect
      of dietary and exercise intervention over 12 weeks.
    

Detailed description: 
      Our hypothesis is that the vascular health in these children will improve at the end of
      intervention. The results of this study will help us in our long-term objective of improving
      vascular health of children with congenital/acquired heart disease, a group particularly at
      risk for premature atherosclerosis.
    

Intervention name(s): Diet and Exercise Intervention
Intervention type(s): Other
Intervention description(s): Remote Dietary and Exercise Intervention Program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Trial of Health at Work Workplace Health Intervention
Condition: Workplace Health
Study type: Interventional

Summary: 
      This pilot study will compare workplace health intervention delivered by advisors based in GP
      practices with normal GP care to assess the usefulness of the concept and its potential for
      wider use in a larger randomised controlled trial.
    

Detailed description: 
      The aim of this pilot study is to examine the impact of H@W intervention(s) on job retention
      and return to work and compare outcomes with those from normal GP care. The target population
      for this study is people still at work but experiencing a work-related health problem as well
      as those off work. For the purpose of the study, short term sickness absence is defined as a
      period of 4 weeks or less and long term sickness absence defined as a period of 4 weeks or
      longer. Hypothesis

      That H@W intervention in comparison to standard care:

        -  promotes work retention

        -  enables a quick and sustained return to work for those on short term sick leave (4 weeks
           or less)

        -  achieves sustained return to work for those on long term sick leave of 4 weeks or more.
           This could include a phased return to work.

        -  achieves positive outcomes which could mean leaving one job and starting another.
    

Intervention name(s): Health at Work workplace health advice and support
Intervention type(s): Behavioral
Intervention description(s): The intervention group will receive additional support from a H@W Workplace Health Advisor who will deliver an intervention aimed at sickness absence prevention or sustained return to work, depending on individual circumstances. The intervention will be standardized as far as possible to show types of activity undertaken with participants, their GP, line managers, human resources departments and trade union representatives.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: early intervention; sickness absence; return to work; primary care
Effects of Vitamin B1 in Type 1 Diabetic Patients
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether benfotiamine supplementation can reduce
      markers of microvascular complications in type 1 diabetic patients.
    

Detailed description: 
      Despite intensive strategies designed to achieve good metabolic control, diabetic patients
      are still at a markedly increased risk of eye and kidney disease, nerve damage, limb
      amputation, stroke and myocardial infarction as a result of long-term hyperglycemia. It has
      recently been shown that supplementation with lipid soluble vitamin B1 (benfotiamine) in
      diabetic rats could effectively block three major biochemical pathways of hyperglycemic
      damage. It has also been shown that supplementation prevented the development of experimental
      diabetic retinopathy and nephropathy, without changes in glycemic control. However, the
      applicability of the above findings to humans is unknown, and the diabetic late complications
      in experimental animals do not in every aspect mirror the human diabetic complications.

      This project will allow us to evaluate the potential of benfotiamine to reduce or prevent the
      further development of microvascular disease in type 1 diabetics.
    

Intervention name(s): Placebo; Benfotiamine
Intervention type(s): Drug; Drug
Intervention description(s): Placebo for benfotiamine; 300mg/day
Other intervention name(s): S-benzoylthiamine O-monophoshate
Intervention MeSH terms: Benphothiamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetes Complications; benfotiamine; type 1 diabetes; elevated urinary albumin excretion; nerve function; advanced glycation end products
Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.
Condition: Parkinson Disease; Attention Disturbances
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The researchers aimed to investigate the relationship between the asymmetric dopaminergic
      degeneration and the attentional resources in a group of patients with Parkinson's disease
      (PD).
    

Detailed description: 
      To bypass the impaired habitual motor-behavioural control, Parkinson's disease (PD) patients
      may exploit the network of goal-directed mode of action. The frontostriatal connections
      underline this functioning, that is based on attention. Since the cognitive processes are
      related with dopamine, the asymmetrical degeneration of the dopaminergic system affects
      differently the right side affected (RPD) and the left side affected (LPD) PD patients.

      The aim of the study was to investigate the relationship between the asymmetric dopaminergic
      degeneration and the attentional resources in a group of patients with PD.
    

Intervention name(s): MIRT
Intervention type(s): Other
Intervention description(s): 4-week multidisciplinary intensive rehabilitation treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer
Condition: Ovarian Neoplasms
MeSH terms: Ovarian Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of
      oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when
      combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy
      (carboplatin and paclitaxel alone) in female patients with advanced ovarian cancer.
    

Detailed description: 
      Oregovomab is an investigational drug previously used in clinical trials as an
      immunotherapeutic treatment of ovarian cancer patients whose tumor cells express the tumor
      associated antigen, CA125. The active component of oregovomab is the activated murine
      monoclonal antibody B43.13, an immunoglobulin G1k (IgG1k) subclass immunoglobulin that binds
      with high affinity (1.16E10/M) to CA125.

      CA125 is a surface glycoprotein antigen that is expressed on more than 80% of all
      non-mucinous epithelial ovarian carcinomas where it occurs at elevated levels in the serum of
      patients with ovarian cancer. Little is known about its biological function. CA125 is
      associated with a large molecular weight mucin-like glycoprotein complex of 200-250
      kilodaltons (kDa) and its genetic structure has recently been elucidated. There is good
      evidence to suggest that CA125 is a relevant target antigen for antigen-mediated
      immunotherapy of ovarian cancer.

      The study will compare the effectiveness of oregovomab (a murine monoclonal antibody directed
      against cancer antigen 125 (CA125)) when combined with first-line chemotherapy (carboplatin
      and paclitaxel) to first-line chemotherapy (carboplatin and paclitaxel alone) in female
      patients with advanced ovarian cancer.
    

Intervention name(s): Carboplatin; Paclitaxel; oregovomab
Intervention type(s): Drug; Drug; Biological
Intervention description(s): carboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks [21 days]); Paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks [21 days]); oregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle).
Other intervention name(s): OvaRex
Intervention MeSH terms: Paclitaxel; Carboplatin; Oregovomab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian; cancer; neoplasm; adenocarcinoma; CA125
Combination of Docetaxel, Cisplatin, and Capecitabine (DCX) in the Treatment of Nasopharyngeal Carcinoma
Condition: Nasopharyngeal Neoplasms
MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB)
      nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given
      to those patients in order to shrink the tumor volume and facilitate the following radiation
      therapy. Thus, in this study, the investigators use the combination of
      Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic nasopharyngeal
      carcinoma patients, in order to evaluate the efficacy and safety profiles.
    

Detailed description: 
      The standard treatment strategy for locally advanced (stage IVA) and metastatic (stage IVB)
      nasopharyngeal carcinoma has not been defined yet. Generally induction chemotherapy is given
      to those patients in order to shrink the tumor volume and facilitate the following radiation
      therapy.However, the standard chemotherapy regimen has not been defined yet.Combination of
      cisplatin and fluracil is the commonly used regimen with tolerable toxicity. Recent studies
      have found that docetaxel has good efficacy on nasopharyngeal carcinoma patients, and
      capecitabine can be safely used instead of fluracil. Thus, in this study, we use the
      combination of Docetaxel+Cisplatin+Xeloda (DCX) to treat locally advanced and metastatic
      nasopharyngeal carcinoma patients, in order to evaluate the efficacy and safety profiles.
    

Intervention name(s): Docetaxel; Cisplatin; Capecitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 75mg/㎡,d1; 25mg/㎡,d1-3; 2000mg/㎡,d1-14
Other intervention name(s): Taxotere; xeloda
Intervention MeSH terms: Docetaxel; Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nasopharyngeal carcinoma; induction chemotherapy; docetaxel; xeloda
Study on the Role of Brentuximab Vedotin as Single Agent in the Treatment of Relapsed/Refractory CD30+ PTCL Patients
Condition: Lymphatic Diseases
MeSH terms: Lymphatic Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-arm, open-label, multicenter, clinical trial to evaluate the efficacy and
      safety of Brentuximab Vedotin (BV) as a single agent in relapsed/refractory CD30+ PTCL
      patients.
    

Detailed description: 
      BV will be administered as a single IV infusion on Day 1 of each 21-day cycle. Measures of
      anti-cancer activity will be assessed using the revised response criteria for malignant
      lymphoma (Cheson et al. 2007).

      Computed tomography (CT) scans (chest, neck, abdomen, and pelvis) and PET scan will be
      performed at baseline and Cycles 3, 8, 12, and 16. Patients will have an End of Treatment
      (EOT) assessment 30 ± 7 days after receiving their final dose of study drug. Patients with at
      least stable disease will enter short follow up phase till month 24 with radiology assessment
      every 6 months and visit every 12 weeks. After month 24 and for all patients with progressive
      disease, long-term follow-up assessments (including survival, disease status and next therapy
      information) will be performed every 12 weeks until either patient death or study closure,
      whichever occurs first.
    

Intervention name(s): Brentuximab Vedotin
Intervention type(s): Drug
Intervention description(s): Brentuximab vedotin will be administered on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg and is administered by outpatient IV infusion given over approximately 30 minutes
Other intervention name(s): SGN35
Intervention MeSH terms: Brentuximab Vedotin
Intervention model: Single Group Assignment
Intervention model description: Subjects will receive 1.8 mg/kg of brentuximab vedotin as an iv infusion administered on Day 1 of each 21-day cycle for a maximum of 16 cycles.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PTCL; CD30+