cyrilzakka/clinical-trials huggingface dataset:
Evaluation of an Endoscopic Suturing System for Tissue Apposition in Colonic Polypectomy

The purpose of this study is to show that the surgical site in the bowel wall can be sewn closed in the colon or intestine, with a new sewing device after removal of a benign polyp according to standard of care.

Polypectomy is the medical term for removing polyps. Polyps are abnormal like growths that protrude into the lining of the bowel. Because a polyp cannot always be removed by a snare, the usual and simplest method, (for example, it may be too flat), a doctor (colorectal surgeon) may perform a polypectomy using a technique called Endoscopic Mucosal Resection (EMR). Endoscopic Mucosal Resection (EMR)is based on the concept that endoscopy (looking at the inside of your colon with an instrument called a colonoscope) provides visualization and access to the innermost lining of the gastrointestinal tract, where a polyp originates. The Endoscopic Mucosal Resection (EMR)performed during this study will be standard of care according to the current practice at University Hospitals of Cleveland.

Following polyp removal, the study procedure will be performed. A medical device is being evaluated to help with this procedure by closing the wound that remains after the polyp is removed without performing an open surgical operation. This involves suturing (sewing) the tissue back together with a Tissue Apposition System (TAS). This is also called tissue approximation. The sewing device being evaluated has been cleared by the Food and Drug Administration (FDA).

Up to 20 men and women, at least 21 years of age, requiring removal of a colonic or rectal polyp that cannot be removed by traditional colonic polypectomy, will be asked to enroll in the study. Following polyp removal, these patients will have the remaining tissue area closed using the study sewing device. Participation in this study will last approximately three months.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age;
* Willing to give consent and comply with evaluation and treatment schedule;
* Approved for polypectomy per standard preoperative endoscopic evaluation;
* Established indication for a procedure greater than colonoscopy and colonic polypectomy. This will include polyps not suitable for current practice (snare procedure) endoscopic resection by nature of size or location, in which an intestinal resection, laparoscopic-assisted polypectomy is required;
* Surgical area viewable with laparoscopy.

Exclusion Criteria:

* Physical or psychological condition which would impair study participation;
* Unable or unwilling to attend follow-up visits and examinations;
* Concurrent surgical procedure;
* Pregnancy;
* A polyp which appears to be an invasive cancer, even with negative pathology;
* A polyp with biopsies suspicious for invasive cancer;
* Participation in any other investigational device or drug study within 30 days prior to enrollment; or
* Any condition which precludes compliance with the study.
BUMPP: A Study to Better Understand Mood During the Perinatal Period

The overall goal of the BUMPP study is to improve our understanding of a range of moods, feelings, and thoughts that women can experience during pregnancy and soon after they give birth. This study will examine how these moods, feelings, and thoughts are related to changes in hormonal and immune health that women experience during and after pregnancy, and to mother-baby relationships and infant development in the early postpartum months.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* 35 weeks pregnant or less
* carrying only one baby (not twins or triplets)
* first time giving birth
* can speak/read/write in English

Exclusion Criteria:

* major medical health condition like a heart, kidney, or liver disease or HIV
* currently taking corticosteroids, progesterone, or immunosuppressive medications that might impact the samples we are taking in this research study
* have regularly used alcohol, tobacco, or recreational drugs (such as marijuana or prescription drugs for non-medical reasons) during pregnancy (regularly means more than a few times total, such as on a monthly, weekly, or daily basis)
RCT for Electroconvulsive Treatment Followed by Cognitive Control Training

Major depressive disorder (MDD) is worldwide one of the most prevalent and disabling mental health conditions. Electroconvulsive therapy (ECT) is a safe and effective treatment even though 6-month relapse rates are high. Cognitive side effects of ECT, such as reduced cognitive control, might trigger mechanisms that increase relapse in patients. As such, cognitive control training (CCT) holds promise as a non-pharmacological strategy to improve long-term effects of ECT (i.e., increase remission, and reduce depression relapse).

Eighty-eight participants aged between 18-70 years with major depressive disorder who start electroconvulsive treatment (ECT) will be included in this randomized controlled trial (RCT). Following (partial) response to ECT treatment (at least a 25% reduction of clinical symptoms), participants will be randomly assigned to a computer based CCT or active placebo control. A first aim of this RCT is to assess the effects of CCT compared to an active placebo condition on depression symptomatology, cognitive complaints, and quality of life. Secondly, participants will be monitored every two weeks for a period of six months following CCT/active placebo, allowing the detection of potential relapse of depression. Thirdly, the investigators will assess participant evaluation of the addition of cognitive remediation to ECT using qualitative interview methods (satisfaction, acceptability and appropriateness). Finally, in order to further advance our understanding of the mechanisms underlying effects of CCT, exploratory analyses may be conducted using facial video footage collected during the CCT/active control phase of the study.

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 70 years old
* current major depressive episode with treatment resistance
* eligibility and consent for ECT treatment
* ability to provide consent to study

Exclusion Criteria:

* neurodegenerative disorder or MOCA \< 18
* catatonia
* schizophrenia
* alcohol use disorder in previous year
* prior ECT treatment
* insufficient computer knowledge or analphabetism
Administration of Systemic Corticosteroids and the Recovery of Gustatory Functions in Patients With COVID-19

Coronavirus is a global pandemic with a high mortality rate; it is started in china in 2019 and rapidly spread worldwide, reaching its epidemic peak in March 2020 Coronavirus is a family of viruses that usually affect animals. They also can affect the respiratory system of humans, causing different manifestations such as difficulty in breathing, coughing, fever, invasive lung lesions, and viral pneumonia

Coronavirus is a global pandemic with a high mortality rate; it is started in china in 2019 and rapidly spread worldwide, reaching its epidemic peak in March 2020 Coronavirus is a family of viruses that usually affect animals. They also can affect the respiratory system of humans, causing different manifestations such as difficulty in breathing, coughing, fever, invasive lung lesions, and viral pneumonia Smell and taste dysfunction is more frequent in the initial stages of covid-19 infection that occur within the first five days and may be used as pivotal symptoms in the early diagnosis of the disease

Eligibility Criteria:
Inclusion Criteria:

* all signs and symptoms were recorded included fever \>38 °C, fatigue, myalgia, arthralgia, sore throat, headache, and its localization (diffuse, frontal, other localization), rhinorrhea, nasal obstruction, epistaxis, tinnitus, and hearing loss, sneezing, cough, sputum production, hemoptysis, dyspnea, respiratory rate \>22, crackling sounds during auscultation, nausea, vomiting, diarrhea, and abdominal pain.

Exclusion Criteria:

* patients with absolute contraindications for systemic corticosteroids administration, pregnant women, smokers, and patients with any systemic disease or taking any medications that cause loss of taste or smell were excluded from this study.
School-Based Preventive Asthma Care Technology: A Trial Using a Novel Technology to Improve Adherence

The goal of this new translational project is to test the feasibility and effectiveness of implementing school-based directly observed therapy of preventive asthma medications in a real-world setting, using state-of-the-art web-based technology for systematic screening, electronic report generation, and communication between nurses, caregivers, and primary care providers. With the use of a novel method to improve adherence and subsequently reduce morbidity, the investigators hypothesize that this novel adaptation of school-based asthma care will; 1) be feasible and acceptable among this population and among school and community stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). The investigators anticipate that enhancing preventive healthcare for young urban children with asthma through partnerships with the schools using a novel technology will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs.


Eligibility Criteria:
Inclusion Criteria (all 4 criteria must be met):

1. Physician-diagnosed asthma (based on parent report).
2. Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following:

   1. An average of \>2 days per week with asthma symptoms
   2. \>2 days per week with rescue medication use
   3. \>2 days per month with nighttime symptoms
   4. ≥2 episodes of asthma during the past year that have required systemic corticosteroids
3. Age ≥3 and ≤10 years.
4. Attending school in participating Rochester City School District preschools or elementary schools.

Exclusion Criteria:

1. Inability to speak and understand English. (\*Parents unable to read will be eligible, and all instruments will be given verbally.)
2. No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate phone number).
3. Family planning to leave the school district within fewer than 6 months.
4. The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures.
5. Children in foster care or other situations in which consent cannot be obtained from a guardian.
A Study to Estimate Safety and Efficacy of Sorafenib (BAY43-9006) in the Treatment of Hepatocellular Carcinoma

Evaluate anti-cancer activity (e.g. proportion of patients with confirmed complete response or partial response) in patients with advanced, inoperable biopsy-proven hepatocellular carcinoma.

In addition to the key secondary outcome parameters the following exploratory parameters were evaluated in subpopulations:

* Pharmacokinetics (PK) profile of Sorafenib
* Plasma and tissue tumor biomarkers

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed primary hepatocellular carcinoma (HCC)
* Inoperable disease (T2-T4, any N, M0 or M1) or refused surgery
* Measurable disease
* At least 1 bidimensionally measurable lesion of at least 2 cm by computed tomography (CT) scan or magnetic resonance imaging (MRI)
* Presence of at least 1 of the following:
* Alpha-fetoprotein greater than the upper limit of normal (ULN)
* Hepatitis C antibody positive
* Hepatitis B surface antigen positive
* Child's Pugh class A or B
* Candidate for systemic therapy

Exclusion Criteria:

* Fibrolamellar disease mixed histology
* Metastatic brain or meningeal tumors
The Comparison of Tunnel Morphology and Graft Healing in Anterior Cruciate Ligament Reconstructions Using Peroneus Longus And Hamstring Tendons

1. Comparison of the grafts using Magnetic Resonance Imaging (MR) to determine whether their maturation and bone integration are different,
2. Comparison of the grafts using Computerized Tomography (CT) to determine whether their effects on the tunnels opened in cruciate ligament reconstruction surgeries are different,
3. In the event that graft healing and effects on the tunnels differ between grafts, determination of whether these differences are related to patient clinics,

The project method; Patients who will be operated with 2 different grafts used in anterior cruciate ligament surgeries will be included in 2 different randomized groups of 29 people (hamstring and peroneus groups) determined by obtaining their informed consent before the surgery and then,

1. The maturation of the grafts will be measured and compared with the SNQ (Signal/Noise quotient) value and the graft-bone integration with the SI (Signal Intensity) value with the Magnetic Resonance (MR) to be taken at the 1st year controls after the surgery,
2. Changes in tunnel morphology; The volume of the tunnels will be measured with the Computerized Tomography (CT) imaging method to be taken prospectively within the first week after the surgery date and 1 year after the surgery date and the changes within 1 year will be calculated by comparing them.
3. In the outpatient clinic follow-ups of both groups; Knee laxity will be obtained with Lachman, Anterior drawer and Pivot shift tests and knee scores and activity levels will be obtained using IKDC, Lysholm, Marx scales and it will be examined whether these data are related to SNQ, SI and tunnel expansion.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged between 18 and 45 years.
* BMI in the range of 18 to 28.
* Diagnosed with an anterior cruciate ligament (ACL) injury preoperatively confirmed by MRI.
* Patients for whom it is deemed appropriate to harvest ipsilateral hamstring tendons or Peroneus Longus tendon for use as a graft.

Exclusion Criteria:

* History of previous surgery on the affected knee or ankle.
* Presence of multiple ligament injuries in the affected knee.
* Diagnosis of advanced osteoporosis.
* ACL injuries that occurred more than 12 months prior to surgery.
* Evidence of unstable meniscal injury on preoperative MRI, which may alter the postoperative rehabilitation process.
* Evidence of unstable meniscal injury on preoperative MRI, which may alter the postoperative rehabilitation process.
Reconstruction of Hand Soft Tissue Defects

Evaluation of distally based posterior interosseous artery flap in reconstructing hand soft tissue defects that may result from trauma, extensive burns, tumor resection or congenital deformities.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with complex defects over the dorsal and palmar aspect of the wrist and the hand up to the proximal interphalangeal joint level, the whole thumb, and the first web space.
2. Small to moderate hand defects resulting from post-traumatic raw areas, post-traumatic deformities, postburn deformities and scar, post tumor resection, and congenital hand deformity.
3. Availability of a healthy donor site.

Exclusion Criteria:

1. Patients with a major uncontrollable medical illness.
2. Chronic heavy smokers.
3. Traumatic injury to the donor site.
4. Complex defects of the hand beyond the PIP joint level.
Relative Oral Bioavailability of BI 44847 as Suspension Compared to Tablet and the Influence of Food Anf of BI 44847 as Solution Compared to Tablet in Healthy Male Volunteers

Study to investigate the relative oral bioavailability of 400 mg BI 44847 as suspension vs. 400 mg BI 44847 as tablet, to investigate a food effect on the 400 mg tablet pharmacokinetic (PK) and to investigate relative oral bioavailability of 40 mg BI 44847 as solution vs. 40 mg BI 44847 as tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
* Age ≥ 21 and Age ≤ 50 years
* BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL) within four weeks prior to administration or during the trial
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of study centre
* Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \> 120 ms. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \> 450 ms or QT\> 500 ms)
* A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
* The use of concomitant medications that prolong the QT/QTc interval
Cognitive Integrated Motor Training (CM) to Improve Gait and Balance and Reduce Falls in Older Adults With Mild Cognitive Impairment

Problems with walking and balance are common in older adults with mild cognitive impairment. Walking and balance problems limit independence and increase risk for injuries due to falls. The purpose of this research study is to test the effectiveness of training that combines moving and thinking tasks, referred to as Personalized cognitive integrated sensorimotor virtual reality (VR)/mixed reality (MR) training on walking and balance ability. The study will also help to understand the changes in thinking ability and brain activity as a result of this training in older adults with mild cognitive impairment.

The study will evaluate the differences between two intervention groups (n=20 each): 1) personalized cognitive integrated sensorimotor VR/MR training (CM), and 3) standard of care (CTRL) on gait, balance, community ambulation, and cognitive functions, as well as underlying biomechanical and neurophysiological mechanisms to understand the changes due to CM.


Eligibility Criteria:
Inclusion Criteria:

* Between the age of 65 and 85 years for older adults.
* Montreal Cognitive Assessment (MOCA), 17 \< MOCA \< 24
* Medical clearance will be obtained from my clinician. If participants physician is unavailable the study team clinician will provide the medical clearance.
* Adequate cognitive function to give informed consent, understand the training and instructions, use the device and give adequate feedback.
* Able to stand for 5 minutes.

Exclusion Criteria:

* Body weight over 135 kgs.
* Uncontrolled or unstable seizure disorder.
* Severe joint contracture or spasticity of the ankle that limits passive range of motion as determined by the team.
* History of severe cardiac diseases such as myocardial infarction, coronary artery disease, cardiac arrhythmia, or congestive heart failure.
* Neuromuscular or neurological pathologies (e.g., spinal cord injury, stroke) that will interfere with ambulation.
* Uncontrolled or unstable orthostatic hypotension.
* Pre-existing conditions resulting in significant disruption in alignment or function of the lower limb during standing.
* History of injury or pathology to the lower limbs in the past 6 months or any medical issue precludes full weight-bearing and ambulation (e.g., orthopedic injuries).
* Diplopia or nystagmus.
* Walking speed from 10MWT \>0.8m/s.

MRI specific exclusion criteria:

* Medications such as: steroids, benzodiazepines, and neuroleptics. The study doctor will review the medications with the participant.
* clip to repair a cerebral aneurysm (broken blood vessel in the head), cardiac pace-maker, cochlear implants (internal hearing aids) or metal fragments or pieces in the eyes or any other part of the body.
* non MRI compatible metal in any part of the body.
* Medical clearance from a physician that it is medically unsafe to receive regular MRI.
* Engage in the professions of painting or welding or other occupation that prevents me from getting a regular MRI.
* claustrophobia (fear of enclosed spaces).
* History of schizophrenia or bipolar disorder.
Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical)

The purpose of this research study is to test whether a Computerized Rotational Head Impulse Test-Vertical (crHIT-vertical) is able to reliably evaluate the vertical semicircular canals in patients with vestibular dysfunctions.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be willing to tolerate the placement of a set of goggles on their face
* Controls:

  1. no history of dizziness or imbalance
  2. normal responses on rotational chair testing
* Patients: persons clinically diagnosed with vestibular disorders

Exclusion Criteria:

* Pregnancy
* Neurodegenerative diseases
Jugular Venous Oxygen Saturation During Therapeutic Hypothermia After Cardiac Arrest

The purpose of this study is to understand what happens to cerebral metabolism during therapeutic hypothermia for hypoxic brain injury following cardiac arrest.

Latest international guidelines recommend the use of therapeutic hypothermia in patients who have had cardiac arrest and remain in coma after return of spontaneous circulation. This is recommended essentially to limit the cerebral injury caused by cardiac arrest and possibly amplified upon reperfusion. At times, although a spontaneous circulation has returned, cerebral oxygenation may remain inadequate due to inadequate perfusion pressure, and hypothermia, by reducing cardiac output and cerebral blood flow could actually aggravate this phenomenon. The rewarming period is thought to be at greatest risk of inadequate oxygenation for the increase in metabolic demand. With this study we aim to understand what happens to cerebral oxygenation and metabolism during therapeutic hypothermia for cardiac arrest through cerebrovenous oxygen saturation monitoring and in particular, to see whether through this type of monitoring we could recognize otherwise unnoticed periods of inadequate cerebral oxygenation.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients in coma after cardiac arrest undergoing therapeutic hypothermia

Exclusion Criteria:

* Age \< 18
* Pregnancy
* Traumatic brain injury
* Contraindications to cannulation as severe coagulopathy