bioihbjkbjnl/mcl2 huggingface dataset:
Does Vaginal Packing Influence Patient Outcomes Following Vaginal Reconstructive Surgery?
Condition: Vaginal Packing Following Pelvic Reconstructive Surgery
Study type: Interventional

Summary: 
      Vaginal packing is used routinely following vaginal reconstructive surgery. Despite little
      data to support the practice, purported benefits include reduced pelvic fluid accumulation or
      blood loss. Patients often complain of discomfort associated with the packing or its removal.

      This randomized controlled trial seeks to document differences in subjective impressions of
      pain in women undergoing vaginal repairs treated with and without packing. The investigators
      also aim to assess differences in postoperative fluid collection in those with and without
      packing.
    


Intervention name(s): Vaginal packing; No vaginal packing
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Endothelin Antagonism in ANCA Vasculitis
Condition: Vasculitis
MeSH terms: Vasculitis
Study type: Interventional

Summary: 
      Patients with vasculitis commonly develop cardiovascular disease. The reasons for this are
      not clear and is not adequately treated with current drugs. It is thus understand the reasons
      why patients with vasculitis develop cardiovascular disease in order to develop new drugs to
      reduced this risk.

      Endothelin is a chemical produced by blood vessels that contributes to the development of
      hypertension and cardiovascular disease Higher than normal levels of endothelin are seen in
      patients with vasculitis but how this contributes to cardiovascular disease in patients with
      vasculitis is not clear. By using drugs that block the effects of endothelin ('endothelin
      receptor antagonists') the investigators can hopefully reduce the risk of cardiovascular
      disease in patients with vasculitis. The purpose of the study is to ascertain if endothelin
      receptor antagonists improve blood vessel function in patients with vasculitis.
    

Detailed description: 
      Vasculitis patients and healthy controls matched for age, sex will be enrolled into the
      study. Patients will attend for 4 study days >1 week apart, whereas controls will attend for
      single day. Circulating Mφ and other immune cells will be confirmed using FACS prior each
      study.

      Study 1 Both patients and control will attend for visit 1: assessment of vascular function
      using forearm plethysmography as part of case control study.

      Vasculitis patients will then attend for visits 2, 3 & 4 as part of randomised three way
      crossover study (randomised & infusions given in a double-blind method): comparison of the
      effects of selective ETA receptor antagonism (BQ123; 1000nmol/min for 15min iv), mixed ETA/B
      antagonism (BQ123/788; 1000 nmol/min & 300 nmol/min for 15 min), and placebo on systemic
      haemodynamics.
    

Intervention name(s): BQ123; BQ123/788; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous infusion of BQ123 ( selective ETA antagonist ); or BQ123/788 (mixed ETA/B antagonists); Intravenous infusion of saline
Other intervention name(s): Selective ETA antagonism; mixed ETA/B antagonism; Saline
Intervention MeSH terms: cyclo(Trp-Asp-Pro-Val-Leu)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: endothelin;; blood pressure;; vasculitis
Treatment of Polydrug-Using Opiate Dependents During Withdrawal
Condition: Opiate Dependence; Drug Dependence; Substance Withdrawal Syndrome
MeSH terms: Opioid-Related Disorders; Substance Withdrawal Syndrome; Substance-Related Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Managed detoxification is a first and necessary step prior to treatment and rehabilitation.
      Detoxification can be a major obstacle for some patients, and the availability of managed and
      safe withdrawal is a prerequisite for long-term treatment.

      In our clinical practice we have felt the need for a standardised and safe detoxification
      treatment regimen for our opioid addicts, as dependence on multiple drugs is so common.

      Objectives

        1. To assess whether a novel standardised treatment regimen - Buprenorphine (BPN) combined
           with Valproate (VPA) - will result in fewer withdrawal symptoms during detoxification of
           opiate-polydrug users than the existing treatment regimen, i.e. Clonidine (CLN) combined
           with Carbamazepine (CBZ).

        2. To determine whether there are differences in treatment retention between the BPN/VPA
           and the CLN/CBZ groups.

        3. To assess differences in clinical side-effects and biochemical interactions between the
           two treatment regimens.
    


Intervention name(s): Buprenorphine; Valproate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Buprenorphine; Valproic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opiate dependence; Benzodiazepine dependence; Polydrug Abuse; Detoxification; Withdrawal Treatment
Factors Influencing Cesarean Section Rate: Does the Audit Still Work?
Condition: Cesarean Section
Study type: Observational

Summary: 
      To elucidate the audit's effect on caesarean section rate, and also define the factors
      influencing the caesarean section rate.

      From Jan 2007 , pregnant women who delivered in a medical center will be included
      retrospectively in this study. Our monthly cesarean section audit, focusing on discussing the
      indications of cesarean section, began from July 2008. Clinical data, indications of cesarean
      section, and perinatal outcomes were compared between the cases of before and after the
      audit. Multivariate logistic regression was performed to identify factors affecting cesarean
      section rate.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        pregnant women who delivered in a medical center will be included retrospectively in this
        study
      
Keywords: cesarean section rate; the cesarean section rate audit
Nutritional Supplements and Nitric Oxide Bioactivity
Condition: Nitric Oxide; Vascular Function; L-Arginine; Nitrate / Nitrite; Postprandial Metabolism
Study type: Interventional

Summary: 
      Obese people have a disturbed postprandial metabolism and thereby a decreased postprandial
      vascular function. Nitric oxide plays an important role in the postprandial vascular
      function. Multiple studies already focused on various nutritional compounds to improve the
      postprandial vascular function by increasing the nitric oxide bioactivity. However, the vast
      majority of the trials has been performed with relatively high doses of the individual
      components, which are problematic to convert into daily food measures, thereby preventing
      translation of these findings. Well-designed trails studying the effect of feasible amounts
      of nutritional supplements on the bioactivity of nitric oxide and vascular function are
      missing.
    


Intervention name(s): L-Arginine; Nitrate / Nitrite; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Acute intervention (3 hours); Acute intervention (3 hours); Acute intervention (3 hours)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study to evaluate the safety and tolerability of escalating single IV doses of
      MEDI-528.
    

Detailed description: 
      The primary objective of this Phase I study is to evaluate the safety and tolerability of
      escalating single IV doses of MEDI-528 administered to healthy adult volunteers.
    

Intervention name(s): MEDI-528 0.3 mg/kg; MEDI-528 1 mg/kg; MEDI-528 3 mg/kg; MEDI-528 9 mg/kg
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose; MEDI-528 (1 mg/kg) administered as a single, IV dose; MEDI-528 (3 mg/kg) administered as a single, IV dose; MEDI-528 (9 mg/kg) administered as a single, IV dose
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Acceptability and Feasibility of a Simplified Medical Abortion Regimen in Georgia
Condition: Abortion, First Trimester
Study type: Interventional

Summary: 
      This study examined the acceptability and feasibility of using a simplified regimen of
      medical abortion in the eastern and western regions of the country of Georgia. It was
      hypothesized that home use of mifepristone and buccal administration of misoprostol would be
      both acceptable and efficacious.
    

Detailed description: 
      The study recruited women with pregnancies up to 63 days gestation. Eligible women took 200
      mg mifepristone. Two days later they took 400 mcg buccal misoprostol, with the option of
      doing so in the clinic or at home. They underwent clinic follow-up 12-15 days after taking
      mifepristone to determine if their medical abortions were complete. The study assessed the
      regimen's efficacy, women's preferences regarding where to administer the medications, and
      the acceptability of buccal misoprostol and of side effects that accompanied women's medical
      abortions.
    

Intervention name(s): Home administration of 200 mg mifepristone; Home or clinic administration of 400 mcg buccal misoprostol
Intervention type(s): Drug; Drug
Intervention description(s): Home administration of 200 mg mifepristone.; Home or clinic administration of 400 mcg buccal misoprostol
Other intervention name(s): Penkrofton
Intervention MeSH terms: Misoprostol; Mifepristone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The overall goal of this study is to address the question of whether progressively lowering
      nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low
      socioeconomic status
    

Detailed description: 
      To address the question of whether progressively lowering nicotine content in cigarettes can
      reduce or eliminate nicotine dependence in low socioeconomic smokers, we will randomize
      smokers to either an Reduced Nicotine Content group with a gradual step-wise reduction in
      nicotine from 11 mg to 0.2 mg per cigarette in five 3-wk stages, or a control group with
      nicotine content similar to their preferred usual brand of cigarettes.

      Overall, we hypothesize that low socioeconomic smokers who switch to progressively lower
      nicotine cigarettes will initially alter their smoking behavior to compensate for lower
      nicotine until cigarette nicotine yields become so low that complete compensation becomes too
      difficult. At that point, smokers will either drop-out or continue to smoke the reduced
      nicotine content cigarettes but with incomplete compensatory behaviors.
    

Intervention name(s): Reduced Nicotine Content Cigarettes; Same Nicotine Content Cigarettes
Intervention type(s): Drug; Drug
Intervention description(s): Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette; about 11.6 mg nicotine per cigarette
Other intervention name(s): Nicotine; Nicotine
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Smoking; Nicotine
Toripalimab Combined With Axitinib as Neoadjuvant Therapy in Patients With Non-metastatic Locally Advanced Nonmetastatic Clear Cell Renal Cell Carcinoma
Condition: Neoadjuvant Therapy of Non-metastatic Locally Advanced Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is design to prospectively investigate the safety and efficacy of Toripalimab
      combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven
      clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the
      immune system by blocking the function of an inhibitory molecule, Programmed cell death-1
      (PD-1). This is a single-institution, single-arm phase 2 clinical trial.
    

Detailed description: 
      This study is design to prospectively investigate the safety and efficacy of Toripalimab
      combined with Axitinib in downsizing tumors in patients with nonmetastatic biopsy-proven
      clear cell renal cell carcinoma. Toripalimab is new antibody that may help activate the
      immune system by blocking the function of an inhibitory molecule, Programmed cell death-1
      (PD-1). This is a single-institution, single-arm phase 2 clinical trial. Patients will
      receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk. Patients then
      will receive partial or radical nephrectomy after neoadjuvant therapy.
    

Intervention name(s): Toripalimab; Axitinib
Intervention type(s): Drug; Drug
Intervention description(s): 240mg, IV (in the vein) on on day 1 of 3-week, 6-week and 9-week for a total of 3 doses prior to partial nephrectomy or radical nephrectomy; 5 mg by mouth twice each day for 12 weeks prior to nephrectomy
Other intervention name(s): anti-PD-1 monoclonal antibody
Intervention MeSH terms: Axitinib
Intervention model: Single Group Assignment
Intervention model description: Before surgery, patients will receive axitinib 5 mg bid combined with Toripalimab 3mg/KG q3w for up to 12 wk.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neoadjuvant therapy; Toripalimab; axitinib; nephrectomy; partial nephrectomy
Effect of Artemisia Dracunculus on Glucose Intolerance, Insulin Sensitivity and Insulin Secretion
Condition: Glucose Intolerance
MeSH terms: Insulin Resistance; Glucose Intolerance
Study type: Interventional

Summary: 
      The term prediabetes has been used to encompass the first alterations on glucose metabolism
      such as impaired fasting glucose and glucose intolerance, and its early detection and
      treatment could prevent the appearance of diabetes mellitus type 2, a high prevalence disease
      worldwide.

      Artemisia dracunculus, also known as estragon, has been used in Ayurvedic medicine for the
      treatment of diabetes.

      Different in vitro and in vivo studies have shown that Artemisia dracunculus increases
      insulin signaling and improves insulin sensitivity.

      The aim of this study is evaluate the effect of Artemisia dracunculus on glucose intolerance,
      insulin sensitivity and insulin secretion.
    

Detailed description: 
      A randomized, double-blind, placebo-controlled clinical trial will be carried out in 24
      patients with diagnosis of glucose intolerance in accordance with the criteria of American
      Diabetes Association (ADA). Glucose, insulin levels, lipid profile, creatinine, uric acid,
      and transaminases will be evaluated. An oral glucose tolerance test with 75 g of dextrose
      will be held.

      12 participants will receive Artemisia dracunculus, 1000 mg, twice per day (2000 mg) before
      breakfast and dinner during 3 months. And other 12 patients will receive placebo with the
      same prescription.

      Area Under de Curve of glucose and insulin will be calculated as well as total insulin
      secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and
      insulin sensitivity (Matsuda index).

      This protocol is approved by a local ethics committee and written informed consent will be
      obtained from all volunteers.

      Results will be presented as mean and standard deviation. Intra an inter group differences
      will be tested using the Wilcoxon signed-ran and Mann Whitney U- test respectively; p<0.05
      will be considered significant.
    

Intervention name(s): Artemisia dracunculus; Placebo
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): estragon, tarragon; calcined magnesia
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a study with two groups of patients with prediabetes. One group received the investigational product (Artemisia Dracunculus) and the other received placebo as control.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Glucose Intolerance; Artemisia dracunculus; Insulin
Holiday Season Weight Change During Islamic Holidays
Condition: Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Observational

Summary: 
      The study involved 30 regular exercisers and 33 non-exercisers. Food records were collected
      five times: before the holiday season, before Ramadan, during Ramadan, during Ramadan Feast,
      and after Ramadan Feast, including the Eid al-Adha period. Anthropometric measurements were
      taken before and after holidays: initially before Ramadan and again after Eid al-Adha.
      Physical activity was recorded for both groups: once before Ramadan for non-exercisers and
      twice (on exercise and rest days) for exercisers.
    

Detailed description: 
      The purpose of this study is to determine the changes in nutrient consumption during the
      holiday season and to assess the changes in body weight, body composition, and blood pressure
      of exercising and non-exercising individuals at the end of this season. In the United States
      of America, the holiday season is the period between Thanksgiving and New Year's Day. In
      Turkey, the holiday season is defined as the period between the Feast of Ramadan and the
      Feast of Sacrifice. A total of 30 individuals who regularly exercise and 33 who do not
      exercise participated in the study. In this study, 3-day food consumption records were taken
      from the participants five times; before the holiday season, before Ramadan, during Ramadan,
      during Ramadan Feast, after Ramadan Feast, and during the Eid al-Adha period. The
      anthropometric measurements of the participants were measured before and after the holidays.
      The first measurement was taken before Ramadan, and the second was taken after Eid al-Adha.
      Physical activity was recorded in the pre-Ramadan period, once for non-exercising
      participants, and twice for exercising participants, on exercise and rest days.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): At least 150 minutes of exercise in a week
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants were recruited from a local activity center, which includes a gym as well as
        art studios, via bulletin board announcement.
      
Keywords: Holiday weight gain; Fasting; Body composition
A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia
Condition: Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicentre, open-label study to assess the safety, tolerability, and efficacy of
      0.5 mg Dutasteride administered once daily for 52 weeks in men with Androgenetic Alopecia
      types III vertex, IV and V per the Norwood-Hamilton classification. The study consists of a
      Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks). A subject who
      completes the full course of study treatment and the final study visit (Week 52; Visit 7)
      will be considered as study completion.
    


Intervention name(s): Dutasteride 0.5 mg
Intervention type(s): Drug
Intervention description(s): Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of Dutasteride and it will be packaged in high-density polyethylene (HDPE) bottles with plastic child-resistant closures.
Intervention MeSH terms: Dutasteride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: male pattern hair loss; hair growth; hair restoration; Dutasteride; Androgenetic alopecia; safety; efficacy
Safety and Tolerability of STP206 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess the safety, tolerability and fecal shedding of STP206 when given as a
      single dose and when given as daily doses for one week.
    


Intervention name(s): STP206 or vehicle control
Intervention type(s): Drug
Intervention description(s): STP206 or vehicle administered as either a single dose or as a daily dose for 7 consecutive days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Healthy volunteers
A Single Center Experience in the Management of Pilonidal Disease
Condition: Pilonidal Sinus
MeSH terms: Pilonidal Sinus
Study type: Interventional

Summary: 
      Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous
      tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the
      presence of sinus tracts with recurrent inflammation and infection. It poses a significant
      healthcare problem due to its related morbidity, impaired quality of life, and financial
      costs.
    

Detailed description: 
      This acquired disease is caused by negative suction of the hair present in the natal cleft
      region, leading to a foreign body reaction and subsequent granuloma . It affects 26 per
      100000 people, and it mainly affects young men . Surgery for PND is frequently performed in
      Egypt by general surgeons, with no published data regarding its incidence or prevalence in
      the Egyptian population.

      The PND patient may report different presentations ranging from asymptomatic disease to acute
      infection and abscess formation. Others may have a chronic disease with recurrent perianal
      inflammation and discharge.

      Multiple surgical options have been described for chronic PND. However, no technique has been
      universally accepted. The idea of any procedure is to excise the pits with the related sinus
      tracts leaving healthy tissue as possible to decrease recurrence. The most commonly performed
      surgical techniques include excision with either primary closure, lay open, or flap-based
      reconstruction.
    

Intervention name(s): surgery
Intervention type(s): Procedure
Intervention description(s): surgery with primary closure, Rhomboid flap , or Rotational flap
Other intervention name(s): surgical procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sacrococcygeal pilonidal sinus; primary closure; limberg flap; rotational flap