cyrilzakka/clinical-trials huggingface dataset:
MDD POC Study GSK372475 Subjects Depressive Disease

To evaluate the efficacy, safety and tolerability of GSK372475 compared with placebo in the treatment of outpatients subjects with major depressive disorder to exhibit decreased pleasure, interest and energy.


Eligibility Criteria:
Inclusion criteria:

* Major depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria)
* Duration of current episode is at least 12 weeks duration and less than 2 years
* Symptoms of decreased energy, pleasure, and interest
* Female subjects who agree to use acceptable methods of birth control throughout the study

Exclusion criteria:

* Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial
* Symptoms of MDE better accounted for by another diagnosis
* Diagnosis of panic disorder / attacks, generalised anxiety, borderline or antisocial personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of screening), bipolar disorder, schizophrenia or any other psychotic disorder(s).
* Started psychotherapy within 3 months prior to the Screening
* Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening
* Received psychoactive drugs within 4 weeks of randomization
* Positive urine drug screen or positive blood alcohol
* Suicidal risk or has had any previous suicide attempt, a family history of suicide attempt
* Positive pregnancy test
* History of seizure disorder, myocardial infarction (\< 1yr), or unstable medical condition
* Failed to respond to an adequate course of pharmacotherapy of at least 2 different antidepressants
Gallium-68 PSMA-11 PET in Patients With Biochemical Recurrence

The investigators are imaging patients with prostate cancer using a new PET imaging agent (Ga-68-PSMA-11) in order to evaluate it's ability to detection prostate cancer in patients with biochemical recurrence after prostatectomy and radiation therapy.

Imaging and staging of prostate cancer is critical for surgical and treatment planning. Patients with suspected metastatic prostate cancer will be imaged using Gallium-68 labeled PSMA-11 in order to demonstrate its utility. The investigators plan to utilize this data to obtain further approvals of the Ga-68-PSMA-11 compound, so that this agent will become available for clinical imaging in prostate cancer patients. In the biochemical recurrence population, the primary objective is to determine the sensitivity and positive predictive value (PPV) on a per-patient and per-region-basis of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Histopathological proven prostate adenocarcinoma.
* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy).

  * Post radical prostatectomy (RP) - American Urological Association (AUA) recommendation

    * PSA greater than 0.2 ng/mL measured more than 6 weeks after RP and,
    * Confirmatory persistent PSA greater than 0.2 ng/mL
  * Post-radiation therapy -ASTRO-Phoenix consensus definition

    * Nadir + greater than or equal to 2 ng/mL rise in PSA
* Karnofsky performance status of greater than 50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent).
* Age \> 18.
* Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

* Investigational therapy for prostate cancer.
* Unable to lie flat, still or tolerate a PET scan.
* Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.
* Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. (Note: This exclusion criteria can be removed if Furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device).
Activated Recombinant Human Factor VII Following Cardiac Bypass Surgery for Paediatric Congenital Heart Disease

This trial is conducted in Oceania. The aim of this trial is to investigate the efficacy of activated recombinant human factor VII and standard treatment compared with standard haemostatic replacement therapy in cardiopulmonary bypass (CPB) surgery for paediatric congenital heart disease.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained from parent or legal guardian before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject
* Children with complex congenital heart disease requiring corrective surgery with cardiopulmonary bypass (CPB)

Exclusion Criteria:

* Congenital heart disease that does not require CPB surgery
Hand Incision Study

The cosmetic outcome of a patient's surgical scar is important for patient satisfaction, especially in more visibly exposed areas of the body such as the hand. A patient's surgical scar often serves as a long-term reminder of their surgery experience, so optimizing final scar appearance should be of high importance. Surgical incision closure techniques and suture materials may vary by individual hand surgeons, even with common hand procedures.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* Able to provide consent
* Undergoing either trigger finger release or carpal tunnel release

Exclusion Criteria:

* Patients \< 18 years old
* Unable to provide consent
* Unable to comply with follow up requirements
Small Macular Holes Treated With Air

Non-inferiority trial comparing intraocular air and gas tamponade for closure of macular holes.


Eligibility Criteria:
Inclusion Criteria:

* Primary MH ≤250 μm
* MH duration ≤12 months
* No previous vitreoretinal surgery in study eye
* Ability to sign informed consent
* Signed informed consent
* Age ˃18 years

Exclusion Criteria:

* Previous vitreoretinal surgery in study eye
* Secondary MH caused by other conditions than vitreomacular traction
* Myopic MH, i.e., excessive myopia (more than -6 dioptres)
* Traumatic MH
* MH secondary to retinal detachment or other retinal diseases
* Previously participation in this study
ASP1517 Phase 2 Clinical Trial - Double-Blind Study of ASP1517 for the Treatment of Anemia in Chronic Kidney Disease Patients Not on Dialysis-

This study is to evaluate the safety and the dose-response of ASP1517 in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently.

To evaluate the safety and the dose-response of ASP1517 on Hemoglobin (Hb) correction in the treatment of anemia in non-dialysis Chronic Kidney Disease (CKD) patients when ASP1517 is applied intermittently. Patients will receive ASP1517 three times a week (TIW) for first 6weeks. Patients may have the second-randomization to TIW dosing or once-a-week (QW) dosing at Week 6, 8, 10, 12, 14 or 16 if patients meet the criteria.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease with an estimated glomerular filtration rate (as calculated by the Japanese GFR estimation equation) of =\<89 mL/min/1.73 m2, and not required dialysis for 3 months since study completion
* The mean of two Hb values at screening test and Hb test (at least one week apart form the screening test) is \<10.0 g/dL, with a difference of ≤1.0 g/dL between the two values
* Both TSAT\>=5% and ferritin \>=30 ng/mL at screening test
* Serum folate ≥4.0 ng/mL and Vitamin B12 ≥180 pg/mL at screening test

Exclusion Criteria:

* Proliferative retinopathy, age-related macular degeneration, retinal vein occlusion and/or macular edema that is considered to require treatment
* Immunological disease with severe inflammation as assessed by the Investigator; even if the inflammation is in remission, the subject is excluded (e.g. lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome, celiac disease, etc).
* Having a history of gastric/intestinal resection considered influential on the absorption of the drug in the gastrointestinal tract or evidence of active gastroparesis.
* Uncontrollable hypertension (more than one third blood pressure values of diastolic BP \>100 mmHg within 16 weeks prior to screening test including)
* Congestive heart failure (NYHA classification III or higher)
* Having a history of hospitalization for stroke, myocardial infarction or lung infarction within 24 weeks before screening test
* Positive for any of the following: anti-hepatitis C virus antibody (anti-HCV Ab); hepatitis B surface antigen (HBsAg); or human immunodeficiency virus (HIV)
* Anemia other than anemia due to low/absent renal production of EPO (e.g., iron deficiency anemia, hemolytic anemia, pancytopenia, etc)
* Using ESA, anabolic androgenic steroid, testosterone enanthate or mepitiostane within 6 weeks before screening test
The Korean TITRATION Study: Comparison of the Self-titration Methods for Glargine-300

The aim of this study is to demonstrate efficacy and safety of self-titration algorithm with Gla-300 using the INSIGHT algorithm (once daily by 1 unit) and the EDITION algorithm (once weekly by 3 units) in Korean patients with T2D.

The primary objective of this study is to obtain efficacy and safety descriptive data on two different titration algorithms: the INSIGHT titration algorithm (self-titration of 1 unit/day) and the EDITION trial algorithm with insulin glargine 300 units/mL (GLA-300) when given as basal insulin in uncontrolled T2DM patients on basal insulin with or without non-insulin anti-hyperglycemic agent (NIAHA) or in insulin naïve patients.

In a Korean, single-center, type 2 diabetes patients with basal insulin therapy will be enrolled. They will be randomly assigned to either titration algorithm for GLA-300. After 12 weeks, the glycemic control, patients' satisfaction to the titration methods and healthcare providers' satisfaction to titration methods will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 19 years
* Treated for T2D for at least 6 months
* Uncontrolled T2D
* Use of SMPG
* HbA1c \> 7% and ≤ 10% in patients with a basal insulin (Gla-100, Gla-300, neutral protamine Hagedorn (NPH), and detemir) or HbA1c \> 7% and ≤ 11% in insulin naive patients
* Signed informed consent

Exclusion Criteria:

* Type 1 diabetes mellitus
* Pregnancy or lactation
* Night-shift worker
* Unwilling to inject insulin or perform SMPG
* Treated with insulin other than basal insulin within the previous 3 months
* Not on stable dose of basal insulin (±20%) in the last 3 months
* Initiation or change in dose of oral anti-hyperglycemic agents in the last 3 months
* History of alcohol or drug abuse
* Active cancer or other significant comorbidities which the investigator would make the patients unsuitable for participating in the study
* Any clinically significant laboratory finding which the which the investigator would make the patients unsuitable for participating in the study
* Known drug allergy to insulin
* Not signed informed consent
* Incompletion of the study
* Participating in another clinical trial
Image Guided Therapy in the Treatment of Gliomas

RATIONALE: New imaging techniques using magnetic resonance imaging give better tumor definition, thus may lead to better tumor targeting and avoid damaging critical parts of normal brain.

PURPOSE: This phase I/II trial is studying how well image-guided therapy works in treating patients with newly diagnosed intracranial glioma.

PRIMARY OBJECTIVES:

I. To correlate the imaging findings with pathological grade following surgery in patients with newly diagnosed intra-cranial gliomas.

SECONDARY OBJECTIVES:

I. To determine the feasibility of defining the optimal target volume for radiation therapy using MR spectroscopy, diffusion, perfusion and functional imaging. II. To monitor therapeutic responses following treatment using MR spectroscopy, diffusion imaging and perfusion study.

III. To monitor changes in neurocognitive functioning following image guided therapy.

OUTLINE: Patients undergo magnetic resonance spectroscopic imaging, functional magnetic resonance imaging (MRI), diffusion-weighted MRI, and perfusion-weighted MRI. Patients then undergo maximum surgical resection followed by intensity-modulated radiation therapy (IMRT) 5 days a week for 6 weeks. After completion of study treatment, patients are followed up every 3 months for the first year then every 6 months for another year.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed, newly diagnosed intracranial glioma
* A diagnostic contrast enhanced CT/MRI demonstrating the lesion prior to registration
* Karnofsky performance status \>= 60
* Ability to undergo MR imaging with the use of Gadolinium dye
* Patient must sign a study specific informed consent form; if the patient's mental status precludes his/her giving informed consent, written informed consent may be given by the patient's legal representative

Exclusion Criteria:

* Inability to obtain histological proof of glioma
* Allergy to Gadolinium contrast
* Any condition including metallic implants or cardiac pace makers that make the candidate ineligible for MR imaging
* Any medical condition including renal or cardiac insufficiency that make the candidate a high risk for gadolinium contrast administration
* Karnofsky performance status of =\< 50
* Prior history of radiation therapy to the brain
* Pregnancy
Comparison of SMS, IVR, and CATI Surveys in Colombia

The objective of the study is to adapt and assess the feasibility, quality, and validity of short message service or 'text message' (SMS), interactive voice response (IVR), and computer assisted telephone interviews (CATI) for collecting information on noncommunicable disease (NCD) risk factors

Using random digit dialing (RDD) sampling technique, RDD participants will be randomized to one of the three arms: 1) SMS or 2) IVR or 3) CATI. Participants in the first study arm will receive an SMS survey. Participants in the second study arm will receive a IVR survey. Participants in the third study arm will receive a CATI survey. The IVR, SMS and CATI questionnaires contain a set of demographic questions and one NCD module (alcohol, or tobacco, or diet, or physical activity, or blood pressure and diabetes). The investigators will examine contact, response, refusal and cooperation rates and demographic representativeness by each study arm.

Eligibility Criteria:
Inclusion Criteria:

* Access to a mobile phone
* Greater or equal to 18 years of age
* In Colombia, conversant in the Spanish language

Exclusion Criteria:

* Less than 18 years of age
Efficacy Assessment of Osteopathic Manipulative Treatment in the Suboptimal Breastfeeding Behaviour

Breastfeeding is one of the prime factors of long-term health protection in newborns, for nutritional, immunological and developmental reasons. In France there is a wide inter-regional variability of breastfeeding rates at discharge. This variability associates different factors involving both, mothers, birth conditions, newborns and mother-child couple. Some approaches, including osteopathy, aim to support early breastfeeding difficulties. As many others non-conventional medicines, there is a huge and growing interest for this alternative therapy and a spontaneous recourse in the first months of life. Nevertheless, neither efficacy nor the benefits have been studied. Thus, our objective is to evaluate for the first time in France, in a randomized, double-blinded design, the efficacy of early osteopathic manipulative treatment (OMT), in suboptimal breastfeeding behaviour healthy newborns.

128 couples mother-child will be randomized in two groups: with or without osteopathic intervention on the newborn.


Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn ≥ 38 weeks of gestation,
* Suboptimal breastfeeding behavior defined by an IBFATmax score \<10 after 2 assessments.(IBFATmax score = maximal score of Infant Breast Feeding Assessment Tool)
* And/ or presence of persistent severe pain (VAS\> 5) at hospital discharge,
* And / or the presence of nipples cracks, grades 2-5 on the NTS scale
* Maternal Project of exclusive breastfeeding.
* Parental informed and consent form signed

Exclusion Criteria:

* Prematurity defined by a gestation \<38 weeks
* Hypotrophy
* Maternal obesity (BMI\>40)
* Multiple pregnancy
* Congenital malformation
* Neonatal pathology incompatible with efficient lactation initiation.
* Mothers minor or major and / or under guardianship and / or with poor understanding of French language
* Previous history of maternal breast surgery or umbilicated nipple
* IBFAT score max \>10 on at least one of the two assessment at Day3.
* Medical contraindication to osteopathy: bone injury (fracture), tendon or ligament (sprain, dislocation etc ...) in the newborn incompatible with effective mobilization.
* Parental consent withdrawal.
* Neonatal pathology incompatible with breastfeeding follow-up in the first month of life.
Mindfulness Training in Special Operations Forces (SOF) Candidates

The overarching goal of this study is to develop, deliver, and investigate the utility and feasibility of train-the-trainer delivery of mindfulness training (MT) in support of improved readiness (across cognitive, affective, and social domains of the human dimension) and improve retention of candidates in the SOF qualification pipeline at the U.S. Army John F. Kennedy Special Warfare Center and School (referred to as SWCS).


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are between 18 and 65 years of age.
* Individuals who are fluent English speakers.
* Individuals who are active-duty service members.
* Men and women of all races and ethnicities.
* Individuals who are willing and able to consent to participate in the study.
* Individuals who are attending Special Warfare Center and School (SWCS).

Exclusion Criteria:

* Individuals who have a medical or neurological condition that might interfere with performance on the task in the study (e.g., epilepsy)
* Individuals with a history of hospitalization for psychological/mental health issues within the last 6 months.
Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.

The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period

This is a two-part Phase 2a study compromising a 12-week, double-blind, placebo-controlled, treatment period followed by a 100-week, open label, treatment period to evaluate short-term efficacy, and the short- and long-term safety of MEDI2070 in subjects with moderate to severe, active CD who have failed or are intolerant to anti-TNFα therapy as determined by the investigator. Approximately 120 subjects will be randomized in a 1:1 ratio to initially receive a fixed IV dose of MEDI2070 or placebo on Week 0(Day1) and Week 4 (Day 29) during the 12-week, double-blind, placebo-controlled, treatment period. At the completion of the double-blind, placebo-controlled, treatment period (Week 12), subjects will have the option to enter a 100-week, open-label, treatment period where they will receive open-label MEDI2070 (SC) Q4W (Week 12 through Week 112). Subjects will be followed for safety at 3 visits over 28 weeks after their last dose of IP. Subjects will also be contacted by phone 36 weeks after their last dose of IP for safety.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed ileal, ileo-colonic, or colonic CD at least 6 months prior to screening.
* Men or women age 18 - 65 years at the time of screening.
* Moderate-sever active Crohn's Disease (CD), defined by a Crohn's Disease Activity Index (CDAI) score higher or equal 220 and lower or equal 450 at Day 1.
* No known history of active tuberculosis (TB).
* Received at least one anti-TNFα agent for the treatment of CD and did not initially respond.

Exclusion Criteria:

* Pregnant or breastfeeding women.
* Presence of ileostomy and/or colostomy.
* Short bowel syndrome.
* Bowel perforation or obstruction.
* History of cancer.
A Phase 2b Study of Inhaled RVT-1601 for the Treatment of Persistent Cough in IPF

Idiopathic pulmonary fibrosis (IPF) is a rare, progressive life-threatening disease that is characterized by exertional dyspnea and persistent dry cough.

Cough in IPF is both a presenting and a complicating clinical feature, which affects approximately three quarters of IPF cases. It is often a debilitating symptom that adversely affects quality of life (QoL) and is usually refractory to medical therapy.

Inhaled RVT-1601 (formerly, PA101B), a new inhalation formulation of cromolyn sodium delivered via the eFlow® Closed System (CS) nebulizer, is being evaluated in this Phase 2b study for the treatment of persistent cough in patients with IPF.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects age 40 through 89 years
* Confirmed diagnosis of IPF with clinical features consistent with the current clinical practice guidelines
* Persistent cough for at least 8 weeks that is primarily due to IPF and not responsive to anti-tussive therapy
* Daytime cough severity score of ≥ 40 mm on a 100-mm VAS
* 24-hour average cough count of at least 10 coughs per hour
* Forced Vital Capacity (FVC) \> 45% predicted value within 4 weeks
* Diffusion capacity for carbon monoxide corrected for hemoglobin (DLCOc) \> 30% predicted value within 4 weeks
* Life expectancy of at least 12 months

Exclusion Criteria:

* Current or recent history of clinically significant medical condition, laboratory abnormality, or illness that could place the subject at risk or compromise the quality of the study data
* Significant coronary artery disease (i.e., myocardial infarction within 6 months or unstable angina within 1 month)
* Upper or lower respiratory tract infection within 4 weeks
* Acute exacerbation of IPF within 6 months
* Lung transplantation expected within 12 months
* Requiring supplemental O2 \> 4 litres/min to maintain peripheral arterial O2 saturation (SpO2) \> 88% at rest
* History of malignancy likely to result in significant disability or likely to require significant medical or surgical intervention within the next 2 years
* Current smoker (i.e., use of tobacco products within the last 3 months)
* Current or recent history of drug or alcohol abuse within 12 months
* Participation in any other investigational drug study within 4 weeks
* Use of certain drugs for cough management within 4 weeks: prednisone, opiates, baclofen, gabapentin, pregabalin, thalidomide, amitriptyline, inhaled corticosteroids, or inhaled bronchodilators
* Use of ACE inhibitors or cromolyn sodium within 4 weeks
* Females who are pregnant or breastfeeding, or if of child-bearing potential unwilling to practice acceptable means of birth control during the study
* History of hypersensitivity or intolerance to cromolyn sodium
A Study to Treat Small Cell Lung Cancer With a Combination of Cisplatin, Pemetrexed, and Radiotherapy

The purpose of this study is to determine the recommended dose of pemetrexed, cisplatin and radiotherapy in the treatment of patients with Small Cell Lung Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Measurable disease with diagnosis of Small Cell Lung Cancer.
* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group performance status schedule.
* Patients must be at least 18 years of age and have at least a 12-week life expectancy.
* No prior chemotherapy and/or prior thoracic radiotherapy.
* Adequate pulmonary function and organ function.

Exclusion Criteria:

* Patients with myocardial infarction within the preceding six months.
* Diagnosis of a serious concomitant systemic disorder.
* Prior radiotherapy to the lower neck or abdominal region.
* Significant weight loss.
* Concurrent administration of any other antitumor therapy.