bioihbjkbjnl/mcl2 huggingface dataset:
Development of a Polyphenol-rich Dietary Preparation for Treating Veterans With Gulf War Illness
Condition: Gulf War Illness
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits
      such as fatigue, headaches, joint pain, insomnia, and memory problems. With no treatment for
      GWI currently available, there is an urgent need to develop novel interventions to alleviate
      major GWI clinical complications. Recent evidence highlights the potential value of
      flavonoids, a subclass of organic chemical called polyphenols abundantly found in some plants
      and common dietary preparations, in helping relieve clinical complications in Veterans with
      GWI. The overall goal is to test whether daily consumption of commercially available Concord
      grape juice, which is very Flavonoid-rich, is effective for treating cognitive deficits and
      chronic fatigue in Veterans with GWI.
    

Detailed description: 
      Gulf War Illness (GWI) is a multi-symptom disorder that is characterized by complex traits.
      Clinical complications of GWI typically persist over long-term, cause significant pain and
      suffering, and interfere with the ability of affected Veterans to successfully integrate back
      into civilian society. There is no treatment for GWI and there is an urgent need to develop
      novel interventions either to resolve underlying GWI mechanisms, or to alleviate major GWI
      clinical complications.

      Recent Evidence highlights the potential value of flavonoids, a subclass of organic chemical
      called polyphenols that are abundantly found in some plants and common dietary preparations
      may help alleviate chronic fatigue and preserve cognitive functions. Based on this, the
      overall goal is to test whether the potential efficacy of dietary supplementation with a
      commercially available flavonoid-rich product, alleviates clinical complications in Veterans
      with GWI. In particular, the researchers propose a randomized, double-blind,
      placebo-controlled Phase I/IIA study to test the feasibility and potential efficacy of
      Concord grape juice dietary supplementation to treat cognitive deficits and chronic fatigue
      in Veterans with GWI.
    

Intervention name(s): Concord grape juice; Placebo Beverage
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily dietary supplementation with a commercially available Concord grape juice.; Daily dietary supplementation with a placebo beverage consisting of water, sugar, artificial flavoring and color that is formulated to look and taste like grape juice and have the same carbohydrate composition and energy load.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Veterans; Gulf War Illness; Gulf War Veterans's Illness; Gulf War Veterans' Medically Unexplained Illnesses
Integration of Family Planning and HIV Services in Tanzania
Condition: HIV Infection; HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      HIV positive women and couples have broad reproductive health needs that are not always met
      within HIV services. The integration of family planning (FP) services into Tanzania's HIV
      Care and Treatment Clinics (CTC) will address the fertility desires of CTC clients and
      ultimately result in the reduction of unintended pregnancies and HIV incidence. One strategy
      for integrating FP and CTC services is to use a "facilitated referral" model. Facilitated
      referrals are enhanced referrals for additional services that have been used in other
      settings and which are the preferred intervention strategy the Government of Tanzania would
      like to pilot test. This study will evaluate the feasibility, effectiveness, and costs of
      implementing a "facilitated referrals" intervention by examining FP use among female clients
      attending HIV/AIDS Care and Treatment Centers. This study will measure whether there is a
      reduction in unmet need for contraception among female CTC clients after the facilitated
      referral integration intervention has been implemented.
    


Intervention name(s): Facilitated Referral
Intervention type(s): Behavioral
Intervention description(s): Seven key steps carried out by CTC and FP staff to encourage completion of FP referral by CTC.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: AE; adverse event; AIDS; acquired immunodeficiency syndrome; ALT (SGPT); alanine aminotransferase; ART; antiretroviral therapy; AST (SGOT); aspartate aminotransferase; DCF; data collection forms; DMC; Data Monitoring Committee; FDA; (U.S.) Food and Drug Administration; GCP; Good Clinical Practice guidelines; HB sAg; Hepatitis B surface antigen; ICH; International Conference of Harmonisation; IND; Investigational New Drug Application; IRB; Institutional Review Board; IU; International units; mg; milligram(s); mm3; cubic millimeter(s); PCR; polymerase chain reaction; SAE; serious adverse event; µg; microgram; ULN; upper limit of the normal range; WB; Western Blot; To inform the Ministry of Health strategy for integrating FP and HIV/AIDS Care and Treatment Services in Tanzania; HIV seronegativity
Ritanserin in Treatment of Cocaine Dependence - 1
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess ritanserin as a pharmacotherapy for cocaine
      dependence.
    


Intervention name(s): Ritanserin
Intervention type(s): Drug
Intervention MeSH terms: Ritanserin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine Dependence; ritanserin
Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the therapeutic effect of DPSG and Placebo gel in the treatment of acne vulgaris.
    

Detailed description: 
      A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group study comparing
      DPSG to ACZONE Gel and active treatment to a Placebo control in the treatment of Acne
      Vulgaris.
    

Intervention name(s): DPSG 7.5%; Aczone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): topical gel; topical gel; topical gel
Other intervention name(s): dapsone; dapsone; Vehicle
Intervention MeSH terms: Dapsone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Influence of Intravenous Lidocaine on the Action of the Neuromuscular Blocker Rocuronium
Condition: Neuromuscular Block
Study type: Interventional
Phase: Phase 4

Summary: 
      Lidocaine is a local anesthetic which is widely used in daily anesthesia and surgical
      practice. It has been shown that intravenous lidocaine given during an operation has
      analgesic properties. Finally intravenous lidocaine is inexpensive and easy to administer and
      safe if non-toxic doses are respected. It is likely that the use of lidocaine infusions
      during anesthesia might increase in the coming years. Neuromuscular blockers (curare like
      substances) are used in anesthesia to facilitate tracheal intubation and to achieve muscle
      relaxation and immobility during surgery. Rocuronium is one of the most widely used
      neuromuscular blocking agents. Local anesthetics, such as lidocaine, are known to potentiate
      the effect of neuromuscular blocking agents. In the study the investigators want to evaluate
      the effect of intravenous lidocaine during the operation on the time course of the
      rocuronium-induced neuromuscular block. A secondary aim is to evaluate intubation conditions
      (lidocaine has been shown also to improve intubation conditions) and safety.
    


Intervention name(s): Placebo; Lidocaine
Intervention type(s): Drug; Drug
Intervention description(s): Immediately before induction, patients will receive 0.15 ml kg-1 of the study drug as an intravenous bolus followed, after tracheal intubation, by a continuous intravenous infusion of 0.2 ml kg-1 h-1. In the Placebo group this will be physiologic saline. The infusion will be stopped after complete recovery from the neuromuscular block.; Immediately before induction, patients will receive 0.15 ml kg-1 of the study drug as an intravenous bolus followed, after tracheal intubation, by a continuous intravenous infusion of 0.2 ml kg-1 h-1. In the lidocaine Arm this regimen corresponds to 1.5 mg kg-1 lidocaine bolus injection and 2 mg kg-1 h-1 lidocaine continuous infusion. The infusion will be stopped after complete recovery from the neuromuscular block.
Other intervention name(s): Rapidocaïne®; Xylocain®
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Patency and Safety of the Drug Eluting Covered Biliary Stent Comparing to the Common Covered Biliary Stent
Condition: Biliary Stricture; Malignant Neoplasms
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      Paclitaxel covered metal biliary stent extents their patency rate comparing to the Common
      Covered Metallic Biliary Stent.
    

Detailed description: 
      Paclitaxel covered metal biliary stent(Mira-Cover Biliary Stent) extents their patency rate
      comparing to the Common Covered Metallic Biliary Stent(Niti-S Biliary Stent.
    

Intervention name(s): Biliary stent
Intervention type(s): Device
Intervention description(s): palliative treatment for malignant patients
Other intervention name(s): Niti-S Mira-Cover Biliary Stent; Niti-S Biliary Stent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: paclitaxel; drug eluting stent
Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers
Condition: Bleeding Peptic Ulcer
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      Endoscopic treatment is recommended for initial hemostasis in nonvariceal upper
      gastrointestinal bleeding. However, the additional hemostatic efficacy of argon plasma
      coagulation (APC) has not been widely investigated. We designed a randomized trial comparing
      APC plus injection therapy vs hemoclipping plus injection therapy for peptic ulcer bleeding.
    

Detailed description: 
      【Goals and Background 】 Endoscopic treatment is recommended for initial hemostasis in
      nonvariceal upper gastrointestinal bleeding. Many endoscopic devices have been demonstrated
      to be effective in the hemostasis of bleeding ulcers. However, the additional hemostatic
      efficacy of argon plasma coagulation (APC) after endoscopic injection therapy has not been
      widely investigated.

      【Study】 From Feb. 2012 to April 2016, consecutive patients with high-risk bleeding ulcers,
      characterized by active bleeding, non-bleeding visible vessels and adherent clots, were
      admitted to our hospital. They prospectively randomly underwent either APC therapy plus
      distilled water injection or Hemoclipping plus distilled water injection. Pantoprazole
      infusion was conducted during the fasting period after endoscopy and orally for 8 weeks to
      encourage ulcer healing. Episodes of rebleeding were retreated with endoscopic combination
      therapy. Patients who did not benefit from retreatment underwent emergency surgery or
      arterial embolization.
    

Intervention name(s): argon plasma coagulation; hemoclipping
Intervention type(s): Device; Device
Intervention description(s): Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan); clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention device: argon plasma coagulation ( (PSD-60/Endoplasma, Olympus Corp., Tokyo,Japan) ; hemoclipping (Olympus HX 110/610) Intervention drug: distilled water design setting: argon plasma coagulation plus distilled water injection vs hemoclipping plus distilled water
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: argon plasma coagulation; hemoclipping; distilled water injection
Protein Requirements in Male and Female Endurance Athletes
Condition: Increased Metabolic Requirement; Healthy
Study type: Interventional

Summary: 
      Protein is an essential macronutrient for post-exercise recovery through its ability to
      provide the amino acid building blocks that support increased rates of muscle and whole body
      protein synthesis.

      Despite the growing understanding of the importance of post-exercise protein in endurance
      athlete populations, the impact of sex and female menstrual cycle phase on protein metabolism
      is not fully understood. To date, no studies have examined protein requirements in female
      endurance trained athletes.

      The aim of the proposed study is to utilize the well-established IAAO method to determine
      protein requirements in endurance trained female and male athletes in a "real-world" and
      at-home setting.
    


Intervention name(s): Amino Acid Intake
Intervention type(s): Dietary Supplement
Intervention description(s): Participants will consume hourly (8 hours) isoenergetic, isonitrogenous beverages containing one of the three protein intakes (0.2g/kg/d, 1.2 g/kg/d, 2.0g/kg/d) assigned in a randomized order between the three metabolic trials. Drinks will be enriched with stable isotope [13C]phenylalanine. The use of stable isotope [13C]phenylalanine will allow for the determination of the fate of AA in the body (incorporation into body protein or oxidation) which can be used to determine protein (AA) requirements.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Eight men and eight women will be provided three different amino acid intakes on three separate occasions (metabolic trials) over 8 hours following a 20km run. All protein intakes have an amino acid composition modelled off of the profile of egg protein.
Masking: None (Open Label)
Primary purpose: Basic Science
Eating in the Absence of Hunger and Caloric Compensation in Preschool Children, Link With Parental Feeding Practices
Condition: Food Intake Regulation in Healthy Children
Study type: Observational

Summary: 
      Objectives: The aims were to measure caloric compensation (CC) and eating in the absence of
      hunger (EAH) in 2 to 7 year-old French children in their regular eating context and to link
      these measurements with individual characteristics (adiposity, age, gender) and parental
      feeding practices.

      Design: Three consecutive weeks an identical lunch was served in four preschool canteens
      reaching 236 children. The first lunch was a control session. For the CC situation (week 2),
      thirty minutes before the lunch children were offered a preload (137 kcal). For the EAH
      situation (week 3), ten minutes after lunch children were exposed to palatable foods (430
      kcal). Food intake was measured at the individual level. Parental eating behaviour and
      feeding practices were measured by questionnaires. Child's height and weight were measured by
      a medical doctor.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The population was composed of 236 children aged 2 to 7 years-old
      
Keywords: Caloric compensation; Eating in the absence of hunger; Children; Parental feeding practices
Molecular Analysis of IgE Antibodies in Walnut Allergic Patients
Condition: Food Allergy
MeSH terms: Food Hypersensitivity
Study type: Interventional

Summary: 
      Accurate diagnosis of food allergy depends on the identification of the causative allergenic
      molecule(s). The proposed study intends to investigate and compare the pattern of IgE
      antibody sensitisation in walnut allergic subjects from three different regions of Europe
      (south (SEU) and central/north (C/NEU), to evaluate the diagnostic utility of a panel of
      novel allergen reagents.
    

Detailed description: 
      Accurate diagnosis of food allergy depends on the identification of the causative allergenic
      molecule(s). Thus, full characterization of the major allergens of walnut and their clinical
      importance is an important undertaking.

      The proposed study intends to investigate and compare the pattern of IgE antibody
      sensitisation in walnut allergic subjects from three different regions of Europe (south (SEU)
      and central/north (C/NEU), to evaluate the diagnostic utility of a panel of novel allergen
      reagents.

      With a view towards improved in vitro diagnostic methods, we intend to evaluate the
      diagnostic potential of recombinant walnut allergens in patients with walnut allergy
      confirmed by a positive provocation or supported by a convincing history of anaphylactic
      reaction(s) to walnut in the past, patients with pollinosis but no symptoms of walnut allergy
      and non-atopic control subjects.
    

Intervention name(s): walnut allergy provocation
Intervention type(s): Other
Intervention description(s): double blind placebo controlled food challenge
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Food allergy; Walnut; Components; Allergens
A Renal Impairment Study for PF-04965842
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1 non-randomized, open-label, single-dose, parallel-group study of PF
      04965842 in subjects with severe renal impairment and subjects without renal impairment (Part
      1) and in subjects with moderate renal impairment (Part 2).
    

Detailed description: 
      This is a Phase 1 non randomized, open label, single dose, parallel cohort, multisite study
      to investigate the effect of renal impairment on the pharmacokinetics, safety and
      tolerability of PF-04965842 after a single 200 mg oral dose. Subjects will be selected and
      categorized into normal renal function or renal impairment groups based on their estimated
      glomerular filtration rate. Part 1: A total of approximately16 subjects will be enrolled;
      approximately 8 subjects with severe renal impairment and approximately 8 with normal renal
      function. After statistical evaluation of results from Part 1, Part 2 may be conducted and
      approximately 8 subjects with moderate renal impairment will be enrolled. The total duration
      of participation from the Screening Visit to Day 4 will be a maximum of 31 days and from the
      Screening Visit to Follow-up Contact/Visit will be a maximum of 67 days.
    

Intervention name(s): PF-04965842
Intervention type(s): Drug
Intervention description(s): PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).
Intervention MeSH terms: Abrocitinib
Intervention model: Parallel Assignment
Intervention model description: Part 1 will be conducted. The 8 subjects from the renal impaired group will be recruited before recruiting the 8 subjects without renal impairment function in Part 1. After statistical evaluation of results from Part 1, Part 2 may be conducted.
Masking: None (Open Label)
Primary purpose: Basic Science
Clinical Study on Veloderm for the Treatment of Split-thickness Skin Graft Donor Sites
Condition: Split-thickness Skin Graft Donor Sites
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multi-center, randomized, open and paralleled positive control study for
      evaluating the safety and efficacy of Veloderm in treatment of split-thickness skin graft
      donor sites. The result implies that Veloerm can do it better than Vaseline gauze in
      accelerating and promoting wound healing of skin graft donor sites. The present study have
      indicated that high permeability of Veloderm dressing to oxygen and water vapor.
    

Detailed description: 
      The rational oxygen permeability of Veloderm dressing also provides a good environment for
      wound healing. Therefore, it can be as a temporary skin substitute in the case of missing
      epidermis to play a role, in order to provide an ideal environment for wound
      epithelialization. As regards safety, 1 adverse reaction occured in test group. It shows
      effusion under the dressing mild inflammatory infiltration on the wound edge. After the
      dressing was changed and the effusion was drained, the patient was relieved. As Veloderm
      dressing itself has no direct anti-inflammatory effects, clinical application as appropriate
      can plus other anti-infective drugs in accordance with patient conditions. In conclusion,
      Veloderm is a safe and effective dressing to accelerate the healing of donor sites in burn
      and plastic surgery. Veloderm can be used as a temporary skin substitute in case of damage of
      skin or loss of superficial epidermal (such as burns, wounds, abrasions, ulcers, sores and
      auto-graft donor areas).
    

Intervention name(s): Crystalline cellulose simple occlusive dressing; Vaseline
Intervention type(s): Device; Device
Intervention description(s): A natural biological film of vegetable origin. It is classified as skin semi occlusive dressing, as a temporary skin substitute in case of skin lesions or loss.; External use
Other intervention name(s): Veloderm
Intervention MeSH terms: Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: skin lesions or defects
Study to Evaluate the Mastery of Inhaler Technique for Budesonide Formoterol (BF) SPIROMAX® as Compared to SYMBICORT® TURBOHALER® as Treatment for Adult Participants With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is conducted to assess whether training participants on proper use of BF SPIROMAX
      and Symbicort TURBOHALER will improve their device-handling technique and potentially improve
      their treatment outcome, that is, better asthma control.
    


Intervention name(s): Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX; SYMBICORT TURBOHALER budesonide and formoterol fumarate
Intervention type(s): Drug; Drug
Intervention description(s): SPIROMAX (BF) Budesonide and formoterol fumarate dehydrate (160/4.5 and 320/9 μg); SYMBICORT® TURBOHALER® (200/6 and 400/12 μg)
Other intervention name(s): SPIROMAX®; SYMBICORT®; TURBOHALER®
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma