cyrilzakka/clinical-trials huggingface dataset:
A Study Comparing Two Different Techniques for Closing the Skin After a Cesarean Delivery

We hypothesize that the use of absorbable staples to close cesarean skin incisions will cause less pain, have better long-term cosmetic results, and result in improved patient satisfaction over standard metal staples. We expect to see no difference in wound complication rates with these two cesarean skin closure techniques.

Type: Randomized controlled trial

Selection of Patients: All pregnant women, undergoing a primary (their first) cesarean delivery at Thomas Jefferson University Hospital will be offered randomization regardless of indication for cesarean delivery. Patients will be excluded from the study if they have a history of a previous cesarean delivery, history of a previous Pfannensteil skin incision for an indication other than for a cesarean delivery (i.e. myomectomy, laparotomy), or a planned vertical skin incision prior to randomization.

Randomization:

Patients will be randomized to skin closure with either the standard staples or the Insorb™ absorbable staple using a computer-generated random number sequence in blocks of six and ten. Allocation will be concealed in opaque, sealed study envelopes that are held on labor and delivery until after consent is obtained. Patients will not be masked as to the type of stapler used however, the investigator obtaining outcome data at six months will be masked.

Procedure:

The cesarean delivery should be performed in the usual fashion according to the surgeon's preference.

We recommend:

* Skin is prepped with a suitable antibacterial agent
* Appropriate prophylactic antibiotics
* Bladder flap should not be routinely created or closed
* Uterus may be closed in 1 or 2 layers
* Peritoneum should not be routinely closed
* Skin wound should be irrigated after fascia closure
* Subcutaneous drains or sutures at surgeon's discretion
* Steri-strips will be placed prior to dressing placement in the OR
* Dressing removal on POD #1
* Metal staple removal prior to discharge from hospital preferred, but ultimately up to surgeon's discretion

Skin incisions will be closed with the assigned stapling device. Addison tissue forceps will be used to evert the skin edges. The recommended distance between staples is 8 to 10mm; however this can be altered at the discretion of the operating physician.

Follow Up:

The subject's age, race, gravidity, parity, reported weight, indication for cesarean delivery, medical co-morbidity, delivery associated complications and findings, charted pain medication and clinic status will be assessed by chart review. Pain, time of placement, patient satisfaction, and cosmetic outcome will be assessed by data sheets filled out by the OR staff, physicians, and patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients at TJUH undergoing primary cesarean delivery via Pfannenstiel incision
* Surgeon willing to adhere to randomized skin staple category

Exclusion Criteria:

* Known allergy to staples or suture
* Vertical skin incision
* Repeat cesarean deliveries
Efficacy of Small Bowel Preparation in Capsule Endoscopy

The best preparation of small bowel is still unknown. The primary aim of this study is to evaluate the polyethylene glycol (PEG) impact of small bowel preparation for unexplained gastrointestinal bleeding exploration. Three different preparations are evaluated in this study.

Now days, the endoscopic video-capsule is the more appropriate exam for unexplained gastrointestinal bleeding exploration. The responsible damage of this unexplained bleeding are frequently small vascular damages, hard to be detected in the bowel or ulcerations or tumors. The exam quality can be limited by food residues, bubbles or bile.

30% of damage are probably undetectable because of a lack of visibility. An efficient preparation will probably increased the quality of the video-capsule exploration.

The bowel exploration by endoscopy video-capsule will be realized in the usual condition. The study included 4 steps:

1. Inclusion
2. Randomization
3. Video-capsule exploration
4. Reading of the video-capsule exam by endoscopist doctors who are in blind.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years old.
* Patients who have an indication for video-capsule endoscopy exploration for unexplained gastrointestinal bleeding associated with anaemia (man : haemoglobin \<13 g/dl and woman haemoglobin \<12g/dl)
* Less than one year Endoscopic assessment by colonoscopy and gastroscopy
* Not participated to an another clinic study.
* Written consent.

Exclusion Criteria:

* Age\<18 years old.
* General physical health deterioration such as dehydration or cardiac insufficiency.
* Clinical or radiological suspicion of digestive stenosis.
* Oral iron taking in the 4 days before video-capsule exploration.
* Functional or organic disorders of the gulp
* Pregnant women.
* Sensibility known about the polyethylene glycol.
* No signed consent.
Study Comparing Test to Aczone 7.5% and Both to a Placebo Control in the Treatment of Acne Vulgaris

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

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

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 years with a clinical diagnosis of acne vulgaris.

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
Hand-Foot Exercises on Peripheral Neuropathy

This study will be conducted to compare the effects of hand and foot exercises on peripheral neuropathy and quality of life in breast cancer patients taking taxanes

İntroduction: New evaluation and care strategies for symptom control are gaining importance due to the increasing prevalence of cancer, expansion of chemotherapy indications, and the development of new chemotherapeutic agents with side effects such as peripheral neuropathy and pain. In the literature review, although there are studies evaluating the effects of neuropathic pain, neuropathy on quality of life and daily living activities, it was determined that there are a very limited number of studies on reducing chemotherapy-induced neuropathy. Simple, at-home exercises to prevent neuropathy can be done daily in a short period of time and do not require special equipment. These exercises may serve as an alternative therapy to improve quality of life by reducing pain in people with neuropathy.

Purpose: This study will be conducted to compare the effects of hand and foot exercises on peripheral neuropathy and quality of life in breast cancer patients taking taxanes.

Method: This study will be conducted using a randomized controlled research design. The research sample will consist of 84 women with breast cancer receiving chemotherapy in the chemotherapy unit of a training and research hospital. Research data will be collected using the Introductory Information Form, Visual Analog Questionnaire (VAS), National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) -Peripheral Neuropathy, EORTC QLQ-CIPN 20. The exercise program will start the week the first neuropathy symptom appears and continue for 8 weeks. Data will be collected in two time periods: the week of starting exercise (T1) and the 8th week after exercise (T2).

Conclusion: It is thought that home-based, simple exercise practices will reduce neuropathy symptoms and improve the quality of life in women with breast cancer receiving neurotoxic chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* The age of 18-80 years
* Clinical diagnosis of breast cancer
* Must be able to read and speak Turkish
* Must be the first time the taxane group receives chemotherapy
* Must be have at least grade 1 neuropathy according to CTCAE
* Must agree to participate in the study

Exclusion Criteria:

* Presence of peripheral neuropathy conditions not caused by chemotherapy \[tumor compression, nutritional disorders, infections, neurological diseases such as stroke, diabetes, etc.\]
* Skin infection, scar tissue, inflammation, or cuts on the hands or feet
* Neuropsychiatric disease
Comparison of the Cuff Pressure of a Taper-guard Cuffed Tube Between Ipsilateral and Contralateral Rotation of Head

This study evaluates the endotracheal tube cuff pressure of a taper-guard cuffed tube during tympanoplasty with ipsilateral rotation of head, compared to the contralateral rotation of head.

The investigators will performed the ipsilateral rotation of head against the fixed tube in half of participants or the contralateral rotation of head in the other half.

The inflation of the endotracheal tube cuff is very useful to prevent aspiration of contaminated substances into lung past endotracheal tube and leakage of gas during positive pressure ventilation. However, excessive inflation of endotracheal tube cuff frequently causes tracheal mucosal damage, which can increase the incidence of sore throat, hoarseness, and coughing after surgery.

Taper-guard cuffed tube was newly developed. Taper-guard endotracheal tube is more effective in providing a sealing effect than a cylindrical endotracheal tube in an in vitro study. However, recently, it was reported that the cuff pressure of a Taper-guard endotracheal tube significantly increased after a positional change from the supine to the lateral flank position, compared to that of a cylindrical endotracheal tube. However, during tympanoplasty, the investigators need to rotate head for proper position.

In this study, therefore, the investigators investigate the difference of the endotracheal tube cuff pressure of a taper-guard cuffed tube between ipsilateral and contralateral rotation of head against the fixed tube during tympanoplasty.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status classification I-III for a tympanoplasty under general anesthesia

Exclusion Criteria:

* history of difficult intubation, limited neck movement, respiratory diseases, and body mass index \>35kg/m2
Accelerated Theta Burst in Chronic Pain: A Biomarker Study

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for chronic pain. In this double blind, randomized control study, participants will be randomized to the treatment group to receive accelerated theta-burst stimulation or to a control group. All participants will be offered the open-label, active treatment 4 week prior to completing the initial 5 days of treatment.

Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression and has been utilized to treat persons suffering from chronic pain. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been very successful in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Patients need to meet at least a 4/10 on a clinical pain rating scale and/or fulfill fibromyalgia diagnostic criteria on the 2010 Fibromyalgia Diagnostic Criteria (Wolfe et al., 2010)
2. Age 18 - 70
3. Right-handed
4. Agree to having fMRI scans as well as rTMS sessions
5. Proficiency in English sufficient to complete questionnaires / follow instructions during fMRI assessments and treatment
6. Women of childbearing potential must agree to use adequate contraception prior to study entry and continue this for the duration of the study
7. Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. Antidepressant must be of the SSRI class only (if currently on a different antidepressant, patients will be switched to an SSRI). They must maintain that same antidepressant regimen throughout the study duration.

Exclusion Criteria:

1. History of MI, CABG, CHF, or other cardiac history.
2. Any condition that would contraindicate MRI (such as ferromagnetic metal in the body)
3. Pregnancy or breastfeeding
4. Any neurological condition, history of epilepsy, history of rTMS failure with FDA approved rTMS parameters, history of any implanted device or psychosurgery for depression, history of receiving ECT. OCD, narcolepsy or any additional significant neurological disorder as determined by the PI.
5. Autism spectrum disorder
6. Inability to stop taking medication contraindicated with treatment
7. Any significant psychiatric disorder as identified on the Mini International Neuropsychiatric Interview and determined by the PI
8. A positive urine toxicology screen
Noninvasive Neuromodulation to Reserve Diastolic Dysfunction

This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS, but the sequence will be randomized. Patients will be randomly assigned (1:1) to active/sham or sham/active LLTS. LLTS will be performed using a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to the tragus of the ear, which is innervated by auricular branch of the vagus nerve. Echocardiography will be performed after 30 minutes of LLTS or sham stimulation to assess diastolic function. Five-minute ECGs will be obtained for HRV analysis every 15 minutes of stimulation (total of 4 recordings).


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients older than 18 year old
2. Evidence of diastolic dysfunction on echocardiogram within 24 months of study enrollment

Exclusion Criteria:

1. Left ventricular dysfunction (Left ventricular ejection fraction \<40%)
2. Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases)
3. Recent (\<6 months) stroke or myocardial infarction
4. Severe heart failure (NYHA class III or IV)
5. Recurrent vaso-vagal syncopal episodes
6. Unilateral or bilateral vagotomy
7. Pregnancy or breast feeding
8. Sick sinus syndrome (without a pacemaker), 2nd or 3rd degree AV block, bifascicular block or prolonged (PR\>300ms) 1st degree AV block
Clinical Study on the Effect of Improving Sleep Quality on Cognitive Function in Patients With Epilepsy

Epilepsy is one of the common chronic diseases of the central nervous system. 30% to 40% of patients with epilepsy have varying degrees of cognitive impairment, which affects their quality of life. At present, the treatment of cognitive impairment in patients with epilepsy is relatively scarce, and the therapeutic effect is still not ideal. Recent studies have shown that sleep disorder is also an important factor causing cognitive dysfunction, and improving sleep quality has a prospect to become a new way to treat cognitive impairment in patients with epilepsy. The purpose of this study is to observe the relationship between sleep and cognitive function in patients with epilepsy, and to improve the sleep quality of patients with epilepsy, so as to provide new ideas for improving cognitive impairment in patients with epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* 1. In accordance with the diagnostic criteria of epilepsy; 2. History of epilepsy ≥ 1 year; 3. Epilepsy with cognitive impairment; 4. Age 7-65 years old; 5. There was no change in the type and dose of antiepileptic drugs during the experiment; 6. Patients and their families were aware of this study and signed an informed consent form.

Exclusion Criteria:

* 1. Status epilepticus; 2. Complicated with severe infection, cerebrovascular diseases, malignant tumors, other nervous system diseases, and systemic diseases that can involve the nervous system (such as immune diseases, etc.), serious dysfunction of heart, liver, kidney and other organs; 3. Non-epileptic seizures such as syncope and hysteria; 4. Women during lactation or pregnancy; 5. Combined use of sleeping and sedative drugs; 6. There are contraindications of melatonin and percutaneous vagal nerve stimulation (tVNS).
Early Mobilisation Following Discectomy

After lumbar discectomy 1st postoperative day high intensity exercise training reduced hospital stay, pain and sick leave without side effects in the two year follow-up period.

Postoperative pain is a major cause of delayed convalescence after discectomy. Different analgesic treatments with the use of local analgesics and steroid can reduce the immediate postoperative pain and convalescence after surgery. In orthopaedic and abdominal surgery accelerated stay programs with early mobilisation have reduced pain in the early postoperative periode. The late convalescence after discectomy for herniated disc disease can be reduced with the use of epidural steroids.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary lumbar herniated disc disease who have received and performed a standardized conservative treatment program with intensive exercises.
* Oral and written acceptance.
* Age 18 and above.

Exclusion Criteria:

* Patients with central or lateral spinal stenosis due to spondylosis or disc degeneration who needed bilateral decompression, laminectomy or fusion.
* Patients with cauda equina syndrome who needed acute operative treatment.
Mesenchymal Stem Cells and Amniotic Membrane Composite for Supraspinatus Tendon Repair Augmentation

This is a non-randomized clinical trial conducted in a single tertiary hospital which investigates the efficacy of allogeneic adipose-derived mesenchymal stem cells and human amniotic membrane (AAdMSC-HAM) composite for supraspinatus tendon repair augmentation

Supraspinatus tendon tear is the most common factor causing shoulder pain, mainly resulting in discomfort and functional deficit in individuals over the age of 35. Supraspinatus tendon repair surgery represents one of the most widely performed types of orthopedic operation. Nevertheless, concerns persist regarding tendon-to-bone healing during the postoperative period. Despite advancements in surgical technique, re-tear of a previously repaired supraspinatus tendon is a fairly common complication, especially in a larger size tear. Such repair technique employing suture anchor devices alone has not yet produced functional results demonstrating both anatomical and biomechanical properties. Therefore, tendon tissue engineering using a combination of scaffolds, cells, and growth factors stimulation offers a potential solution as a biological augmentation in tendon repair.

Human amniotic membrane (HAM) has been widely used as a natural scaffold in tissue engineering due to many of its unique properties such as providing growth factors, cytokines and tissue inhibitors of metalloproteinases, adequate mechanical strength, and biocompatibility. Whereas, mesenchymal stem cells (MSCs) constitute one of the adult stem cells that promote replacement and repair of damaged tissue along with normal tissue turnover. These MSCs are seeded to the HAM scaffolds to biologically augment tendon repair, with MSCs acting as cytokines/growth factors to stimulate tissue repair. This approach serves as the foundation to conduct the present study. The investigators aim to investigate the efficacy of using allogeneic adipose-derived MSCs and human amniotic membrane (AAdMSC-HAM) composite for supraspinatus tendon repair augmentation.

Eligibility Criteria:
Inclusion Criteria:

* Suffering from complete/total tear of supraspinatus tendon for a duration of fewer than 12 months
* Diagnosis is established based on clinical condition and ultrasonography or MRI examination

Exclusion Criteria:

* Patients with comorbid diseases: Diabetes Mellitus, Rheumatoid Arthritis, and other inflammatory diseases.
* Patients presenting with other related injuries, such as fractures or dislocation around the shoulder joint.
The Effect of Lifestyle Intervention Versus Gastric Bypass on Various Comorbidities in Morbidly Obese Subjects

This follow up study (\>1 year) aims to compare the effects of lifestyle intervention and gastric by pass surgery on various comorbidities associated with morbid obesity.

Not addressed

Eligibility Criteria:
Inclusion Criteria:

* Morbidly obese patients

Exclusion Criteria:

-
Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects

This study will investigate the bioequivalence and compare the safety profiles following inhalation of Vantobra to TOBI nebulizer solution in healthy subjects.

Bioequivalence will be investigated based on the pharmacokinetic plasma profiles of Vantobra nebulizer solution compared to TOBI nebulizer solution.


Eligibility Criteria:
Inclusion Criteria:

* Male or female healthy subjects of any ethnic origin
* Aged between 18 and 50 years of age
* Body weight of ≥50 kg and body mass index (BMI) between 18.5 and 29 kg/m2
* FEV1 \> 90% of predicted
* Able to demonstrate correct inhaler use
* Written informed consent

Exclusion Criteria:

* History of clinically relevant allergies or idiosyncrasies to tobramycin or any other inactive ingredient(s) of the IMP
* Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis.
* Any evidence of cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric or other diseases at screening
* Surgery of the gastrointestinal or respiratory tract which might interfere with drug absorption
* History of malignancy within the past 5 years
* History of orthostatic hypotension, faintings or blackouts
* Acute or chronic viral, bacterial or fungal airway infections, including laryngeal infections, mouth and throat infections, and hoarseness;
* Other clinically relevant chronic or acute infectious illnesses
* Clinical chemical, hematological or any other laboratory parameters clinically relevant outside the normal range
Diet Quality and Coronary Artery Calcification in Adults With Heterozygous Familial Hypercholesterolemia

The overarching objective is to evaluate the relationship between diet and coronary artery calcification in patients with heterozygous familial hypercholesterolemia (HeFH). We will recruit adults with HeFH. They will have to complete questionnaires on diet, medication and lifestyle. Coronary artery calcification will be measured in each patient using a CT scan. Physiological and biochemical data will be collected.

The proposed research will deploy as cross-sectional study including treated adults with genetically-defined HeFH. Once recruited, participants will be asked to complete web-based questionnaires on diet, medication and lifestyle. They will thereafter complete a clinical assessment at the Clinical Investigation Unit of the NUTRISS-INAF Research Centre. Study staff will measure participants' height, weight, and waist circumference. Participants' blood pressure will be measured using an automatic blood pressure monitor (BP Thru, Omron) after sitting quietly for 10 minutes. Three sequential readings will be taken with three minutes between readings. Fasting blood samples (10 mL) will be collected from an antecubital vein. Body composition will be assessed with dual-energy X-ray absorptiometry (DEXA). Finally, participants will be asked to provide the full list of medication they are using, including type, dose and duration of use. Later on the same day, participants will undergo the non-contrast CT scan at the Quebec Heart and Lung Institute. Multidetector CT scans without contrast will be performed using a 256 slices helical scanner (Brilliance iCT, Philips).

Eligibility Criteria:
Inclusion Criteria:

- Genetically-defined heterozygous familial hypercholesterolemia

Exclusion criteria:

* Homozygous FH
* Personal history of cardiovascular disease
* Personal history of cancer