bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of TachoSil® Application on a Colorectal Anastomosis (TC-029-IM)
Condition: Colorectal Anastomosis
Intervention: TachoSil®
Intervention description: Sterile, ready-to-use, absorbable sponge for intra-operative topical application. It consists of an equine collagen sponge coated with the fibrin glue components human fibrinogen and human thrombin.
Surgery was performed according to the hospitals' local standards. When the anastomosis was performed, all enrolled subjects had TachoSil® applied around the anastomotic line. TachoSil® was therefore an add-on therapy.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colorectal Anastomosis; Colorectal Resection; Tachosil

Summary:

      The primary objective is to evaluate if the application of TachoSil® on a colorectal
      anastomosis is feasible and safe.

      The secondary objective is to establish and describe optimal application methods to be used
      for educational purposes in future trials.
    

Eligibility criteria:

        Inclusion Criteria - at screening:

          -  Has the patient given informed consent according to local requirements before any
             trial-related activities? A trial-related activity is any procedure that would not
             have been performed during the routine management of the subject.

          -  Is the subject 18 years of age or above?

          -  Is the subject scheduled for elective resection of the rectum?

          -  Is a colorectal anastomosis below the peritoneal reflexion planned?

        For females of childbearing potential:

          -  Does the patient use an acceptable contraceptive method (contraceptive pills,
             injection of prolonged gestagen, subdermal implantation, hormonal vaginal devices,
             transdermal patches or intrauterine device (IUD))?

          -  Is the blood or urine pregnancy test negative?

        Exclusion Criteria -at screening:

          -  Is the subject scheduled for emergency resection of the rectum?

          -  Does the subject suffer from inflammatory bowel diseases?

          -  Does the subject have a history of hypersensitivity reactions after application of
             human fibrinogen, human thrombin and/or collagen of any origin?

          -  Has the subject participated in any other trial with an investigational medical
             product (IMP) or device within 30 days before inclusion in this trial?

          -  Does the subject participate or plan to participate in another clinical trial during
             the trial period?

        For females of childbearing potential:

        • Is the subject pregnant or breast feeding?

        Exclusion - peroperative

          -  Was an anastomosis performed differently from what was defined in the inclusion
             criteria?

          -  Did the subject receive any fibrin sealant/glue, excluding TachoSil® , during surgery?
A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV
Condition: HIV; Pregnancy Malaria; Sexually Transmitted Infection
MeSH terms: Infections; Malaria; Sexually Transmitted Diseases
Intervention: Azithromycin/TMPS; Placebo/TMPS
Intervention description: 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit; 2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
Intervention MeSH terms: Azithromycin; Trimethoprim, Sulfamethoxazole Drug Combination
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 308.0
Sex: Female
Minimum age: 16 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: STI Prevention; Cameroon; sub-Saharan Africa; HIV pregnancy; Malaria in pregnancy

Summary:

      More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women
      living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of
      preventing malaria and other common perinatal infections would have great potential to
      improve adverse birth outcomes. The purpose of this randomized controlled trial is to
      evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to
      determine its efficacy and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed HIV-infection (documented in medical record)

          -  Age ≥16 years

          -  Confirmed pregnancy, <28 weeks estimated gestational age (by best obstetric estimate
             which may include ultrasound or fundal height and LMP)

          -  Live singleton pregnancy

          -  Receiving prenatal care at Mboppi Hospital or Mutengene Hospital

          -  Plan to receive follow up prenatal care and deliver at study facility

          -  Capable of providing written informed consent

          -  Able and agree to come to facility for febrile episodes or acute illness during
             pregnancy (with reimbursement of transportation costs).

          -  Agree to avoid antimalarial medications outside of study protocol.

        Exclusion Criteria:

          -  Severe anemia (last hemoglobin <6)

          -  History of severe adverse reaction to co-trimoxazole or azithromycin

          -  Active medical problem requiring inpatient evaluation at the time of screening

          -  Intention of moving far away from the facility during pregnancy or not likely to
             return for follow up care or delivery

          -  Signs or symptoms of early or active labor

          -  History of severe cardiac disease (including congestive heart failure, severe valvular
             disease or arrhythmias).
Orlistat for the Treatment of Type I Hyperlipoproteinemia
Condition: Hyperlipoproteinemia Type I; Hypertriglyceridemia
MeSH terms: Hyperlipoproteinemia Type I; Hypertriglyceridemia; Hyperlipoproteinemias; Hyperlipidemias
Intervention: Orlistat
Intervention description: Orlistat is a gastric and pancreatic lipase inhibitor that is approved by the FDA for weight loss. It is available over-the-counter as 60 mg tablets under the trade name Alli, and available by prescription as 120 mg capsules under the trade name Xenical.
Intervention MeSH terms: Orlistat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 8 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Patients with Type I Hyperlipoproteinemia (T1HLP) have a rare form of hypertriglyceridemia
      marked by significant chylomicronemia and recurrent episodes of acute pancreatitis. T1HLP is
      caused by a deficiency of lipoprotein lipase or one of its cofactors. Many patients are a
      challenge to treat, as the only effective therapy available is an extremely low fat diet.
      This diet is exceedingly difficult to follow, and despite adherence, many patients still have
      chylomicronemia and develop acute pancreatitis.

      Specific Aim: To determine the efficacy of a gastric and pancreatic lipase inhibitor,
      Orlistat, in reducing serum triglyceride levels in patients with T1HLP.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Type I hyperlipoproteinemia

          2. Fasting serum triglyceride levels of greater than 1000 mg/dL

          3. Age > 8 years

        Exclusion Criteria:

          1. Secondary hypertriglyceridemias due to diabetes, renal disease, hypothyroidism,
             alcoholism and drug therapy such as estrogens and estrogen analogues, steroids,
             HIVprotease inhibitors, retinoic acid derivatives and interferons

          2. Pregnant or lactating women

          3. Significant liver disease (elevated transaminases > 2 times upper limit of normal)
             Alcohol abuse (> 7 drinks or 84 g per week for women and > 14 drinks or 168 g per week
             for men)

          4. Severe anemia (hematocrit < 24%)

          5. Drug use (cocaine, marijuana, LSD, etc.)

          6. Major surgery in the past three months

          7. Congestive heart failure

          8. Serum creatinine greater than 2.5 mg/dL

          9. Cancer within the past five years

         10. Gastrointestinal surgery in the past

         11. Current therapy with anti-coagulants, digoxin, and anti-arrhythmics

         12. Current therapy with cyclosporine

         13. Chronic malabsorption syndromes

         14. Cholestasis

         15. Acute illnesses such as acute pancreatitis in the last 8 weeks
A Phase 2b Study of the Efficacy, Safety, and Tolerability of M1095 (Sonelokimab) in Subjects With Moderate to Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: M1095 (Sonelokimab); Placebo; Secukinumab
Intervention description: M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.; Placebo contains no active drug.; Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 313.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type
      psoriasis. Approximately 300 subjects will be enrolled at approximately 60 investigator sites
      in North America and Europe.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female subjects between 18 and 75 years of age.

          2. Moderate to severe plaque-type psoriasis for at least 6 months.

          3. Subject is a candidate for systemic biologic therapy.

          4. Subject has IGA ≥3, involved body surface area (BSA) ≥10%, and PASI ≥12 at screening
             and at baseline.

          5. Subject is able to comply with the study procedures.

          6. Subject must provide informed consent.

        Exclusion Criteria (Main):

          1. Non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g.,
             eczema). (Psoriatic arthritis is allowed).

          2. Other medical conditions, including planned surgery or active infection / history of
             infection, as defined in the study protocol. Subjects will be screened for
             tuberculosis and hepatitis B / hepatitis C.

          3. Laboratory abnormalities at screening, as defined in the study protocol.

          4. Prior use of systemic or topical treatments for psoriasis, as defined in the study
             protocol.

          5. Prior use of any compound targeting IL-17, more than two biologic therapies,
             ustekinumab within 6 months, or TNF targeting therapies within 12 weeks.

          6. History of suicidal thoughts within 12 months.
Telotristat With Lutathera in Neuroendocrine Tumors
Condition: Neuroendocrine Tumors
MeSH terms: Neuroendocrine Tumors
Intervention: Telotristat (Low-Dose); Telotristat (High-Dose)
Intervention description: Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 750mg per day (250mg TID) for 20 months.; Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 1500mg per day (500mg TID) for 20 months.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: NET

Summary:

      This trial will test the hypothesis that Telotristat treatment increases the antitumor
      efficacy of Lutetium Lu 177 Dotatate therapy in neuroendocrine tumors (NETs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Metastatic, or unresectable, histologically confirmed well-differentiated grade 1 and
             2 neuroendocrine tumor with a positive gallium 68 Dotatate scan within 6 months prior
             to study enrollment

          -  Baseline CT scan or MRI with measurable progressive disease based on RECIST Criteria

          -  Failure of at least one prior systemic cancer treatment for this diagnosis

          -  Recovered from Adverse Events of previously administered therapeutic agents to Grade 2
             or less toxicity according to CTCAE version 5.0

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤2

          -  normal organ and marrow function

        Exclusion Criteria:

          -  Prior exposure to Lutetium Lu 177 Dotatate

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to Telotristat or Lutetium Lu 177 Dotatate.

          -  Presence of unstable angina or myocardial infarction

          -  New York Heart Association (NYHA) Class III or IV heart failure

          -  uncontrolled angina

          -  history of severe coronary artery disease, severe uncontrolled ventricular
             arrhythmias, sick sinus syndrome, or electrocardiographic evidence of acute ischemia
             or Grade 3 conduction system abnormalities

          -  Pregnant or lactating women

          -  Women of childbearing potential or male patients of reproductive potential

          -  Any other significant medical or psychiatric condition, currently uncontrolled by
             treatment, which may interfere with completion of the study
A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; RO4998452; RO4998452; RO4998452; RO4998452; RO4998452
Intervention description: po daily for 12 weeks; 2.5mg po daily for 12 weeks; 5mg po daily for 12 weeks; 10mg po daily for 12 weeks; 20mg po daily for 12 weeks; 40mg po daily for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 394.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of
      RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be
      randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg
      po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take
      their usual dose of metformin throughout the study.The anticipated time on study treatment is
      <=3 months
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, 18-75 years of age;

          -  type 2 diabetes, diagnosed for >=3 months;

          -  either treated with diet, exercise and stable metformin, or with diet and exercise
             alone.

        Exclusion Criteria:

          -  type 1 diabetes mellitus;

          -  currently or within 2 months prior to screening treated with an oral or injectable
             anti-diabetic agent except stable doses of metformin;

          -  currently or within 6 months prior to screening treated with any PPARgamma agonist;

          -  uncontrolled hypertension;

          -  significant pre-diagnosed diabetic complications requiring treatment.
Thiamine as a Renal Protective Agent in Septic Shock
Condition: Sepsis; Kidney Injury; Thiamine Deficiency
MeSH terms: Thiamine Deficiency; Beriberi
Intervention: Thiamine Hydrochloride; Placebo
Intervention description: Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.; 50ml of 0.9% NACL will serve as the placebo
Intervention MeSH terms: Thiamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: A randomization list will be prepared by an independent statistician using 1:1 randomization in blocks of two and four. This list will be provided to the research pharmacy, and the research pharmacy will be the only unblinded people involved with the study, and will have no patient contact or role in the analysis or other aspects of the study. Thiamine is colorless and odorless, and the 200mg dose is mixed in 5mL of normal saline. Placebo will be 50mL of normal saline and is indistinguishable in appearance from thiamine. Study team, clinical team and patient and family will all be blind to the allocation.
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, placebo controlled study to investigate the effect of
      intravenous thiamine (vitamin B1) on renal function in septic shock.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult ≥18 years of age

          2. Suspected or Confirmed Infection (defined as collection of a blood/fluid culture and
             provision of an antimicrobial)

          3. Receipt of a vasopressor agent (e.g. norepinephrine, phenylephrine, vasopressin)

          4. Serum lactate ≥2mmol/L

          5. Creatinine >1.0mg/dL

        Exclusion Criteria:

          1. Clinical indication for thiamine administration (alcoholism, known or highly suspected
             deficiency) or treatment with thiamine beyond the amount found in a standard
             multivitamin within the last 10 days

          2. Renal replacement therapy within the past 30 days

          3. Comfort measures only or anticipated withdrawal of support within 24 hours

          4. Protected populations (pregnant women, prisoners)

          5. Known thiamine allergy
A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Plavix; Aspirin
Intervention MeSH terms: Aspirin; Clopidogrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 48.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Metastatic; Platelet

Summary:

      The purpose of this study is to determine the effects of Plavix and aspirin in women with
      metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with metastatic breast cancer who are completing planned course of chemotherapy
             with planned treatment break

          -  On stable hormone therapy for at least 2 months are also eligible for the study

          -  Estimated survival of at least 3 months

          -  No platelet inhibitor therapy within 1 month of study entry

          -  Platelets ≥ 100,000

          -  Coagulation screening tests within normal range (INR between 0.81 and 1.20)

          -  Normal kidney and liver function as defined by:

               -  Aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase
                  (SGOT))/alanine aminotransferase(ALT) ≤ 2 x Institutional Normal

               -  Creatinine ≤ 2 x Institutional Normal

          -  Able to provide signed, informed consent.

        Exclusion Criteria:

          -  Patients going on to surgery

          -  Patients with a serious bleeding disorder that make them inappropriate candidates for
             NSAID therapy

          -  Patients with history of significant bleeding related to peptic ulcer disease

          -  Patients on standing doses of NSAIDS or platelet function inhibitors

          -  Patients on standing doses of anti-coagulants
Randomised Study Comparing the Effects of Inhaled FF/GW642444M Combination, FF and GW642444M on an Allergen Induced Asthmatic Response
Condition: Asthma
MeSH terms: Asthma
Intervention: FF/GW642444M; GW642444M; Fluticasone Furoate; Placebo
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: allergen challenge; early asthmatic response; mild asthma; late asthmatic response

Summary:

      We propose to use an inhaled allergen challenge model to explore the individual contributions
      of the components of a novel long-acting beta agonist/ inhaled corticosteroid combination
      product and its components on protection from allergic triggers in asthma
    

Eligibility criteria:

        Inclusion Criteria:

        - Body mass index within the range 18.5-35.0 kilograms/metre2 (kg/m2).

          -  Females of non-child bearing potential.

          -  Documented history of bronchial asthma, first diagnosed at least 6 months prior to the
             screening visit and currently being treated only with intermittent short-acting beta
             -agonist therapy by inhalation

          -  Pre-bronchodilator FEV1 >70% of predicted at screening

          -  Subjects who are current non-smokers

          -  Methacholine challenge PC20 < 8 mg/mL at screening

          -  Screening allergen challenge demonstrates that the subject experiences an early
             asthmatic response

        Exclusion Criteria:

          -  Current or chronic history of liver disease, or known hepatic or biliary abnormalities

               -  Subject is hypertensive at screening

               -  Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to
                  the first dose of study medication.

               -  History of life-threatening asthma

               -  Symptomatic with hay fever at screening or predicted to have symptomatic hayfever

               -  Unable to abstain from short acting beta agonists

               -  Unable to abstain from antihistamines

               -  Unable to abstain from other medications including non-steroidal
                  anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-asthma
                  anti-rhinitis or hay fever medication

               -  The subject has participated in a study with a new molecular entity during the
                  previous 3 months or has participated in 4 or more clinical studies in the
                  previous 12 months

               -  undergoing allergen desensitisation therapy