cyrilzakka/clinical-trials huggingface dataset:
Evaluation of a Powered Stapler System on Surgical Interventions Required During Laparoscopic Sleeve Gastrectomy

This study will provide clinical data in an observational setting. Individuals undergoing LSG, and who meet study entry criteria, may be enrolled. LSG procedures will be performed according to institutional standard-of-care (SOC) using the study stapler. All study subjects will be followed for approximately 4 weeks for safety and outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for laparoscopic sleeve gastrectomy;
* Subject meets NIH weight loss surgical criteria;
* BMI ≤ 60 kg/m2;
* Willing to give consent and comply with study-related evaluations; and
* At least 18 years of age

Exclusion Criteria:

* Previous bariatric procedures, including gastric banding;
* Prior gastric surgery;
* Scheduled concurrent surgical procedure (hiatal hernia repair, cholecystectomy allowed);
* Pregnancy;
* Known or suspected uncontrolled bleeding disorders;
* History of chronic steroid use;
* Patients who have undergone significant upper GI surgery leading to adhesion; formation, as determined by the Principal Investigator;
* Physical or psychological condition which would impair study participation;
* The patient is judged unsuitable for study participation by the Investigator for any other reason; or
* Unable or unwilling to attend follow-up visits and examinations.
Fascial Distortion Model in Tension Type Headache

Tension-type headache is a headache that starts from the cervical and suboccipital regions, spreads from the back of the head to the parietal, frontal and temporal regions, and is felt in the form of compression, pressure and heaviness.

Increased muscle and fascia tone in the cervical and cranial region, together with active trigger points and factors that trigger pain, cause tension-type headache. Head and neck fascia serves as an important proprioceptive structure in our body. Abnormal inputs from mechanoreceptors and structures around the joint cause deterioration in joint position sense. This study was planned to investigate the effects of the new facial distortion model on pain intensity, cervical posture and joint position sense, unlike the manual techniques used in previous studies in tension-type headache.

This study was planned as a randomized controlled trial to investigate the effect of fascial distortion model on pain severity, cervical posture and joint position sense in patients with tension headache. Individuals with tension-type headache will be divided into control (n=15) and study group (n=15) by simple random method. Fascial distortion modeling will be applied to the study group for a total of 4 weeks, one session a week for 30 minutes. No application was made to the control group. Evaluations will made for all individuals twice, at baseline and after 4 weeks. Pain severity of individuals was evaluated with VAS and McGill-Melzack Pain Scale, cervical posture with Posturescreen Mobile application, joint position sense with laser cursor-assisted angle repetition test.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of tension-type headache,
* the ages of 20-50 years,
* must be headache complaint for at least 6 months,
* Pain is at least 4 on the visual pain scale.

Exclusion Criteria:

* diagnosis of ervical disc herniation,
* diagnosis of sinusitis, migraine and vertigo,
* diagnosis of scoliosis,
* diagnosis of radiculopathy,
* Having a history of surgery Tumor, cyst or similar findings, Having received any physical therapy for the cervical region before, Having any psychological disorder It is the use of any painkillers during the treatment.
A Study to Test How Well Different Doses of BI 1356225 Are Tolerated by Men and Women With Obesity or Overweight

The primary objective of this trial is to investigate safety and tolerability of BI 1356225 in male and female patients with overweight and obesity following oral administration of multiple rising doses per day over 28 days. Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1356225 after multiple oral dosing. Additionally, the relative bioavailability (BA) of midazolam and celecoxib in the presence and absence of BI 1356225 will be evaluated


Eligibility Criteria:
Inclusion criteria

* Male and female patients, age ≥ 18 and \< 70
* Body Mass Index ≥ 27 kg/m2 and \< 40 kg/m2 at screening
* Stable body weight (defined as no more than 5% change) within 3 months prior to screening
* further inclusion criteria apply

Exclusion criteria

* Females of childbearing potential
* Clinically relevant concomitant disease per investigator judgment
* Any condition or disease requiring permanent pharmacotherapy during the trial
* Any history of lifetime suicidal behaviour and any suicidal ideation of type 2 - 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 12 months
* further exclusion criteria apply
Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest

The objective of this study is to estimate the feasibility and safety of early weaning from ICU treatment in patients after cardiac arrest and an early (\< 12 h) favourable EEG pattern (indicating no or mild postanoxic encephalopathy).

Comatose patients after cardiac arrest are treated on intensive care units with sedative medication, targeted temperature management (TTM), mechanical ventilation, and hemodynamic support. Despite substantial variation in the severity of the encephalopathy and even lack of unequivocal evidence of efficacy of sedation and TTM, all patients receive standard treatment. The severity of the postanoxic encephalopathy can reliably be assessed with the electroencephalogram (EEG). A continuous EEG pattern within the first 12 hours after cardiac arrest ("favorable EEG") is strongly associated with a good neurological outcome and reflects a very mild or transient encephalopathy. The investigators hypothesize that this subgroup of patients, with a favorable EEG will not benefit from prolonged sedation and TTM.

The objective of this study is to estimate the feasibility and safety of early weaning from ICU treatment in patients after cardiac arrest and an early (\< 12 h) favourable EEG pattern. The study design is a cluster randomized crossover design with two treatment arms. The intervention contrast will be early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate (intervention group) vs. standard care, including sedation and TTM for at least 24-48 hours (control group). The investigators will include forty adult patients admitted to the ICU with postanoxic encephalopathy after cardiac arrest and an early (\<12 hours) favorable EEG pattern.

Eligibility Criteria:
Inclusion Criteria:

* Patients after cardiac arrest admitted to the ICU for treatment with sedation, TTM and mechanical ventilation.
* Age 18 years or older.
* Continuous EEG measurement started within 12 hours after cardiac arrest.
* Favourable EEG pattern within 12 hours after arrest, defined as a continuous background pattern (NVN, 2019; Ruijter et al., 2019).
* Possibility to stop sedative treatment within three hours after identification of a favourable EEG pattern.
* Written informed consent (deferred).

Exclusion Criteria:

* A known history of another medical condition with limited life expectancy (\<6 months).
* Any progressive brain illness, such as a brain tumour or neurodegenerative disease.
* Pre-admission Glasgow Outcome Scale Extended score of 4 or lower.
* Reason other than neurological condition to continue sedation and/or ventilation.
* Follow-up impossible due to logistic reasons.
Hippocampus DBS in Treatment-resistant Schizophrenia

The goal of this clinical trial is to assess the efficacy and safety of hippocampus-targeted deep brain stimulation (DBS) in treatment-resistant schizophrenia. The main question it aims to answer are:

* whether patients with treatment-resistant schizophrenia can benefit from hippocampus-targeted DBS;
* what is the neural and electrophysiological mechanism underlying the treatment effect of hippocampus-targeted DBS.

The first phase of the study will consist of DBS surgery. Participants will receive electrodes implantation in bilateral ventral hippocampus. Continuous stimulation will be applied to optimize and individualize the stimulus parameters. This period is anticipated between 3 and 6 months.

The next phase will consist of the crossover study. Patients who respond to DBS will be randomly assigned to two groups, for a period of 3 months: on stimulation group and off stimulation group. Patients will then be crossed over to the other group for a further 3 months.

Participants will receive PET-CT, clinical assessment and cognitive tests at the main study points to evaluate treatment efficacy and patient tolerance, and to reveal the underlying mechanism of the treatment effect of DBS.

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged between 18 and 55 years.
* Having a diagnosis of schizophrenia according to DSM-IV criteria
* Having a chronic, recurrent course of disease with a five-year minimum duration
* Determined to be treatment-resistant as demonstrated by:

  1. Persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years.
  2. Inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks.
  3. Inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects.
  4. Presence of persistent positive symptom defined as i) requiring a score of 4 (moderate) or more on at least 2 of the next PANSS items: delusions, conceptual disorganization, hallucinatory behavior, suspiciousness and unusual thought content; or as ii) requiring a score of 6 (severe) or more on at least 1 of the above PANSS items.
* Maintaining stable pharmacological treatment for two months preceding screening visit.
* Informed consent

Exclusion Criteria:

* Neurological disease
* Severe physical illness
* Contraindications to neurosurgery, MRI or PET-CT;
* Substance abuse or dependence
* Mental retardation
* Female patients who are pregnant or breastfeeding
* Severe suicide risk and tendencies
Capecitabine in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have recurrent ovarian, fallopian tube, or primary peritoneal cancer.

OBJECTIVES: I. Determine the response rate and time to treatment failure in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with oral capecitabine. II. Determine the tolerability and safety of this regimen in these patients.

OUTLINE: Patients receive oral capecitabine twice daily for 14 days. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 14-35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed recurrent ovarian epithelial carcinoma, fallopian tube cancer, or primary peritoneal cancer previously treated with at least one cisplatin based chemotherapy regimen Prior repeat treatment with a taxane and/or platinum agent allowed Prior repeat treatment with other chemotherapy agent allowed once Recurrent disease defined as: At least one site of measurable disease by radiograph and/or a rise of CA-125 over a minimum of 3 samples to a level of at least 50% of upper limit of normal

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 times upper limit of normal (ULN) SGOT less than 2.0 times ULN Alkaline phosphatase less than 2.0 times ULN Renal: Creatinine no greater than 1.5 mg/dL Other: Must be able to take oral medication

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior fluorouracil based chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified
A Study of the Safety and Efficacy of SP-624 in the Treatment of Adults With Major Depressive Disorder

This is a Phase 2 clinical study evaluating the safety and effectiveness of SP-624 as compared to placebo in the treatment of adults with Major Depressive Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent to participate in the study
* Males and females, aged 18 to 65 years
* In generally good physical health
* Body mass index (BMI) must be between 18 and 40 kg/m2
* Females of reproductive potential and males with partners of reproductive potential must agree to remain abstinent or use adequate and reliable contraception throughout the study and for at least 30 days after the last dose of study drug
* Subjects must meet criteria for moderate to severe Major Depressive Disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI)
* Willing and able to comply with the study design schedule and other requirements

Exclusion Criteria:

* Female who is pregnant, breastfeeding, or less than six months postpartum at Screening
* History or presence of any clinically significant medical condition, disease, or surgical history that could jeopardize the safety of the subject or validity of the study data, or interfere with the absorption, distribution, metabolism, or excretion of the study drug
* Failure to discontinue all psychoactive medications or psychoactive supplements including antidepressants and mood stabilizers, within a time period prior to Baseline corresponding to at least five half-lives of the medication in question
* Presence of a clinically significant abnormality on physical examination or electrocardiogram (ECG), including a corrected QT interval using Fridericia's formula (QTcF) \>450 msec for males and \>470 msec for females
* Presence of uncontrolled hypertension, defined as consistent systolic blood pressure (SBP) \>160 mmHg or consistent diastolic blood pressure (DBP) \>95 mmHg despite present therapy
* Screening laboratory value(s) outside the laboratory reference range that are considered to be clinically significant by the Investigator (clinical chemistry, hematology, coagulation, and urinalysis)
* Screening liver function tests (ALT, AST, Alkaline phosphatase) \> 2x the upper limit of normal
* Subjects who, in the opinion of the Investigator, are not suitable candidates for the study
Does Coffee Consumption Prevent or Shorten Postoperative Ileus After Colon Resection?

The purpose of this study is to determine if consuming an 8 ounce cup of coffee with breakfast and lunch is effective in preventing or reducing postoperative ileus.

Recent evidence has shown that a multimodal rehabilitation program can accelerate recovery of GI function after colon resection. 8 A multicenter, randomized, placebo-controlled, double-blind, phase 3 trial demonstrated that Alvimopan, a peripherally acting mu-opioid receptor antagonist, appears to accelerate GI tract recovery by 1 day, and reduces postoperative ileus-related morbidity without compromising opioid analgesia. 9 Asao et al demonstrated that gum chewing can accelerate recovery of GI function, also by 1 day, after abdominal surgery. 10 Epidural anesthesia has been shown to shorten duration of POI, as well as improve pain control, decrease pulmonary complications, and quicken recovery times. However, it does not appear to reduce overall length of stay. 4 However, Neudecker et al. were unable to reproduce the results of previous trials evaluating the effect of thoracic epidural analgesia on duration of postoperative ileus following laparoscopic sigmoid resection. 11 Given conflicting data, no one single measure has been adopted for the prevention POI.

Recent evidence has shown that coffee may be a stimulant for the GI Tract. A small study of 16 healthy volunteers demonstrated that coffee appears to increase rectal tone thus implying an impact on defecation mechanics.12 Furthermore, several studies have demonstrated caffeinated coffee to be a stimulant of motor activity in the colon.13,14 Given its potential pro-motility properties in the GI tract, it seems reasonable to postulate that coffee, a commonly consumed product by the general public, may play a role in shortening and possibly preventing POI. This directly impacts overall patient satisfaction but will reduce length of stay and overall hospital costs.

Eligibility Criteria:
Inclusion Criteria:

* Elective partial bowel resection with primary anastomosis for either cancer or benign disease.
* Laparoscopy or laparotomy

Exclusion Criteria:

* Total colectomy
* Colostomy
* Ileostomy
* Reversal of a stoma or synchronous resection
* Complete small or large bowel obstruction
* Scheduled to receive other treatments or techniques to reduce ileus

  1. epidural anesthetic tecniques
* Nasogastric tube for any length of timein the post-op period.
A Clinical Trial to Evaluate Pharmacokinetic Interactions and Safety Between Fimasartan and Linagliptin in Healthy Male Volunteers

The purpose of this study is to evaluate pharmacokinetic interactions and safety between fimasartan and linagliptin in healthy male volunteers.

This is an open-label, randomized, multiple-dose, two-period and single-sequence study to evaluate the pharmacokinetics and safety.

Eligibility Criteria:
1. Inclusion Criteria (Total: 5):

1. 19-50 year-old healthy male.
2. 18.5kg/m2 ≤ Body mass index(BMI) ≤ 27kg/m2
3. Subject who has no clinically significant medical history.
4. Subject whose informed consent is obtained and who is willing to comply with protocol.

2. Exclusion Criteria (Total: 19):

1. Sitting systolic blood pressure(SiSBP) ≥ 140mmHg or \< 115mmHg / Sitting Diastolic blood pressure(SiDBP) ≥ 90mmHg or \< 70mmHg
2. Upper Limits of Normal x 1.5 \< Aspartate transaminase(AST), Alanine transminase(ALT), Total bilirubin
3. Creatinine clearance(CrCl) \< 80mL/min (using Cockcroft-Gault formula)
4. Positive results in HBsAg, Hepatitis C virus(HCV) Ab, HIV Ag/Ab, Venereal disease research laboratory(VDRL)
5. Participate in another clinical trial within 12 weeks prior to the first administration of Investigational product(IP).
Aspirin Non-responsiveness and Clopidogrel Endpoint Trial.

In the ASCET study, 1000 patients with documented coronary heart disease will be randomized to either continued treatment with aspirin 160 mg/d or change to clopidogrel 75mg/d. Clinical endpoints will be recorded for at least 2 years and related to the initial aspirin response, assessed by the PFA-100® method, to investigate whether aspirin non-responders have higher composite event rate than responders or whether Clopidogrel treatment in patients non-responsive to aspirin will reduce their risk of future clinical events. The clinical events are the composite of unstable angina, myocardial infarction, stroke or death.

Background: Aspirin is widely used as an antiplatelet drug in patients with coronary heart disease. Despite documented clinical benefit, many patients on aspirin still experience severe cardiovascular events. Several laboratory reports have shown lack of platelet inhibition in 5-40% of aspirin-treated patients, and the term aspirin resistance has been introduced. The clinical relevance of these laboratory findings is, however, still unknown. New antiplatelet drugs have been developed, and the adenosin diphosphate (ADP) receptor inhibitor clopidogrel has at least the same efficacy as aspirin with an acceptable safety profile. Laboratory methods for determination of platelet reactivity and treatment efficacy have been complicated and time consuming. New methodologies, like the PFA-100® system, have made such analyses more suitable for clinical use.

Design: In the ASCET study, 1000 patients with documented coronary heart disease will be randomized to either continued treatment with aspirin 160 mg/d or change to clopidogrel 75mg/d after initial determination of their platelet reactivity while on aspirin treatment. Clinical endpoints will be recorded for at least 2 years and related to the initial aspirin response.

Scand Cardiovasc J. 2004 Dec;38(6):353-6.

Eligibility Criteria:
Inclusion Criteria:

* Stable, symptomatic coronary heart disease, verified by coronary angiography, being treated with angioplasty/stent implantation (PCI) or not.

Exclusion Criteria:

* Indication for warfarin treatment.
* Indication for or contraindication to the study drugs.
* Pregnancy or breast-feeding.
* Malignancy that may interfere with life expectancy.
* Psychiatric disease, mental retardation, dementia, drug abuse, alcoholism or conditions that can severely reduce compliance.
Decentralized Trial in Atrial Fibrillation Patients

The purpose of this study is to validate an approach to decentralize, or virtualize, the clinical trial experience for enrolled subjects, through the coordinated use of multiple digital health and telehealth technologies. The study aims to validate the feasibility, acceptability and best practices of coordinating/integrating several individual digital health technologies to achieve execution of high compliance, cost-efficient, and scientifically sound clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Atrial Fibrillation documented (health record diagnosis or EKG) within the past year and taking an oral anticoagulant (OAC) medication for stroke prevention
* Uses a smart phone daily and is willing to use apps and home devices for the study
* Agreeable to use a Televisit method to conduct all study visits from trial team

Exclusion Criteria:

* Active angina, stable or unstable, requiring urgent cardiovascular functional risk stratification (stress testing or catheterization) or intervention. Or has congestive heart failure that is not compensated or in which the subject is not euvolemic, as determined by the treating MD
* Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
* Does not speak English
MecoExpo Study Protocol

The MecoExpo project seeks to evaluate the in utero exposure of newborns in the Picardie region to commonly used pesticides. These pesticides were selected in a pilot study (the Mecopic study) on the basis of their toxicity (effects on foetal development, endocrine perturbation, neurological toxicity and carcinogenicity) and a certain number of indicators of pesticide use and the presence of pesticide in the environment in Picardie.

These substances (or their metabolites) will be measured in the each newborn's meconium (the first faeces after birth) and each newborn's mother's hair in the Picardie region during the study period. The mother's exposure will also be assessed using a retrospective questionnaire (filled out within a few days of the delivery).

Thus, the MecoExpo project will enable the investigators to:

1. evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and clinical parameters measured at birth (term, length, weight, etc.).
2. map pesticide exposure across the Picardie region.
3. create a meconium bank in Picardie (the first ever meconium bank in France).


Eligibility Criteria:
Inclusion Criteria:

* All newborns in Picardie will be eligible. Good command of the French language by a least one of the two people with responsibility for the child will be required for filling out the questionnaire.
* The mother's place of residence must have been in Picardie during the last two trimesters of pregnancy.

Exclusion Criteria:

* Newborns with foetal distress