cyrilzakka/clinical-trials huggingface dataset:
Clinical Use of an Absorbable Coated Suture Material in Surgery (Safil)

The purpose is to test a coated polyglycolic acid multifilament suture in gastrointestinal surgery as part of a controlled randomized single blinded parallel group trial. The applicability and safety of the strand material used in two suture techniques (2-layer suture technique vs. 1-layer running) are to be tested on the basis of handling characteristics, the operative time consumed for the construction of the 1st anastomosis, the average time of the hospital duration for both patient groups, and the frequency of postoperative complications after discharge, 1 month and a maximum of 3-4 months. The used suture units are counted and the length of sutures determined which will be an indirect measurement of the costs of suture material for the two techniques.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, undergoing a gastrointestinal hand made one-layer running (A) or two-layer (B) anastomotic procedure where the use of synthetic absorbable surgical suture material is indicated.
* Written consent to participate in the study

Exclusion Criteria:

* Emergency patients that cannot be properly informed about the clinical trial and cannot give their written consent
* Pregnancy or lactation period
* Patients suffering from a diffuse purulent peritonitis or generalized diseases, which can have consequences for the healing of the asnastomosis (e.g. ubalanced diabetes, progressed uremia, massive hypoproteinaemia, sever jaundice, generalized intraabdominal tumor metastases, severe tumorous cachexia, severe avitaminosis, chronic liver disease.
* Patients who are undergoing a therapeutic procedure, which can have consequences for the healing of the anastomosis (e.g. treatment with corticosteroids or cytostatics, local radiation in the operating area)
* Laparoscopial Procedures
* Patients who are not willing to cooperate and legally incapacitated people
Tolerability, Safety and Pharmacokinetic Study Of Methosulide in Healthy Adult Subjects

The purpose of this study is to determine the safety and tolerability, and to evaluate the pharmacokinetic characteristics and food effect of Methosulide after oral administration in healthy adult subjects.

1. Dose-escalation study of single oral administration of Methosulide in healthy adults to assess the safety and tolerability.
2. Multiple-dose study of Methosulide in healthy adults to assess the safety and tolerability.
3. Dose-escalation study of single oral administration of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics
4. Multiple-dose study of Methosulide in healthy adults to evaluate the pharmacokinetics characteristics
5. Single dose,and cross-over study of Methosulide in healthy adults to evaluate the pharmacokinetic characteristics and effect of food.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, between 18 and 45 years of age, Body Mass Index (BMI) between 19～25 kg/m2, Weight \> or = 50kg
* In good health as judged by the investigator
* Without history of medication within 2 weeks before the test
* Non-allergic constitution, without known drug allergy
* Without history of major organ diseases
* Without other factors affecting drug metabolism, such as smoking (within 2 weeks), drinking (within 2 weeks), or drug abuse history
* Signed informed consent form and Fully understood the contents, process and possible adverse reactions of the test

Exclusion Criteria:

* History of kinds of food or drug allergy, or suffering from allergic diseases or allergic constitution
* Presence (in screening stage) or history of the acute/chronic organic diseases or clinical manifestations: blood system, renal disease, endocrine system, respiratory system, digestive system, cardiovascular system, nervous system, mental disease, allergic diseases (including drug allergy, but not including non-treatment, asymptomatic, seasonal allergy during the period of oral administration)
* History of abuse of Smoking, alcohol, or other drugs
* Severe hemorrhage factors to affect the venous blood collection
* Severe blood loss or blood donation within 3 months before the test
* Participation in other drug trials within 3 months before the test
* Usage of drugs known to have damage to the main organs within 3 months before the test
* Without good compliance, or unable to match with the test
* with a clinically significant abnormality in routine serological detection: including Hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infected
* For childbearing-aged women only, usage of any hormonal contraceptive methods within 3 months before the drug administration; or unable or unwilling to use non-hormonal contraceptive methods to contraception from the day of dosing until 14 days after dosing
* Be otherwise unsuitable for the study, in the opinion of the Investigator.
The Effects of Low- and High-intensity Resistance Exercise on Force-velocity Characteristics in Older Adults

The purpose of this study is to compare the impact of high- and low-intensity resistance exercise on force-velocity characteristics, muscle mass and inflammatory processes in older adults. As all training protocols are designed to end with maximal effort, effects are expected to be similar between groups.


Eligibility Criteria:
Inclusion Criteria:

* age 60 to 80 years

Exclusion Criteria:

* Knee or hip prothesis
* Systematic training
* Cardiovascular disease
* Acute lower back pain
* Dementia
The Epidural Anesthesia on the Intra-operative and Post-operative Amount of Bleeding Post Lower Limb Salvage Surgery

Epidural anesthesia is a very useful tool in lower limb salvage surgery, which helps pain control intra and more importantly post-operative pain. It is a well-known effect of epidural injections to cause a sympathetic stimulation and consequently vasodilatation in the lower limb vessels.

Since epidural catheters can cause vasodilatation in lower limb vessels, they can subsequently lead to increased intra and post-operative bleeding from the surgical wound.

The study will involve all patients having a bone tumor in the lower limb and subjected to tumor resection and reconstruction by prosthesis.

The patient will be randomized according to the administration of epidural anesthesia into two arms, an arm in which epidural anesthesia was employed and another arm in which the patient was subjected only to general anesthesia and the amount of intra and postoperative bleeding will be compared in both arms.

Assessment of intra-operative bleeding will be based upon weighing and counting of the blood soaked dressing and the amount of blood transfusion used.

Assessment of post-operative bleeding will be based upon the amount of blood collected from the suction drain and amount of blood transfusion.

All patient subjected to anticoagulant post-operative or another type of surgery other than implantation of prosthesis will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* lower limb bone tumor
* reconstruction by prosthesis

Exclusion Criteria:

* upper limb and pelvic salvage surgery.
* other methods of reconstruction than prosthesis
* use of tourniquet intra-operative.
* post-operative anticoagulation.
Mindfulness for Cognition in Early-stage Alzheimer's Disease

The goal of this clinical trial is to learn if mindfulness meditation can improve outcomes in older adults with and without cognitive impairment. The main questions it aims to answer are:

1. How does mindfulness impact thinking and memory?
2. How does mindfulness influence brain function and structure?
3. How does mindfulness affect daily function and quality of life?

Researchers will compare all outcomes to one other groups. In one group, individuals will participate in a mindfulness class intervention; in the other group, individuals will not engage in any active interventions immediately, but will be placed on a waitlist for the mindfulness intervention. Researchers will compare all outcomes between the groups groups to determine whether the mindfulness interventions leads to greater improvement compared to no intervention (waitlist group).

Participants will:

* Be randomly assigned to participate in the mindfulness intervention, or no immediate intervention (waitlist)
* Complete paper-and-pencil cognitive testing, surveys, computerized tasks, and neuroimaging measures (EEG and MRI) before and after the intervention

Outcomes will be assess at baseline, 2 months, 4 months and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Healthy older adults will show cognitive performance within 1.0 SD for age \& education adjusted norms on a neuropsychological test battery
* Mild cognitive impairment (MCI) participants will show performance on delayed recall or one more or more other cognitive domains worse than 1.5 SD for age \& education adjusted norms, an MMSE score between 25-30, and a MoCA score between 20-30.

Exclusion Criteria:

* Participants without a computer, smart phone and internet access will be excluded
* If they cannot understand the informed consent form or have moderate dementia.
* Mood disorders (e.g., PTSD, depression, anxiety) or alcohol and drug use that either interferes with day-to-day life or required hospitalization within the past 5 years
* Cerebrovascular disease
* Any medical condition whose severity could significantly impair cognition (e.g., stroke, frontotermporal dementia, Parkinson's disease) are exclusionary
The Effect of Insoles in Plantar Fasciitis

It aims to investigate the effect of two personalized insoles made of different materials designed to reduce pain in individuals with plantar fasciitis on muscle activation and gait parameters at 3-month follow-up.

Plantar Fasciitis (PF) occurs after inflammation and thickening of the fascia, which originates from the medial tuberosity of the calcaneus and runs in the medial plantar part of the foot and has a thick fibrous band structure. It aims to investigate the effect of two personalized insoles made of different materials designed to reduce pain in individuals with plantar fasciitis on muscle activation and gait parameters at 3-month follow-up. The participants of the study will consist of male and female individuals between the ages of 18-65 who are diagnosed with plantar fasciitis by a specialist doctor, who apply to the Prosthetic Orthotics Center (POMER) with a personalized insoles prescription, and who volunteer to participate in the study.Participants will be provided with demographic information, foot function assessment, pedobarographic analysis, gait assessment, muscle activity assessment, and satisfaction assessment. The Foot Function Index (FFI) will be used to assess foot function in individuals with plantar fasciitis. Foot plantar pressure distribution analysis will be performed using the Tekscan software of the EsCoSCAN® pedobarographic assessment device. The plantar pressure analysis and physical evaluation of the individual will be performed and produced by Computer Aided Design and Computer Aided Manufacturing (CAD-CAM) method. Muscle activation data will be recorded with BIOSIGNALSPLUX Researcher Kit brand EMG device. Satisfaction Assessment-Orthotic Prosthesis Users Questionnaire (OPKA-M) will be used. Sensory evaluation will be evaluated with Semmes Weinstein monoflaments. All data will be evaluated by statistical analysis methods.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-65,
* Being diagnosed with plantar fasciitis,
* Being prescribed custom insoles,
* Having complaints for at least 3 months,
* Heel pain complaint is at the plantar medial calcaneal tubercle,
* Pain complaint is most evident in the first steps taken in the morning or in the steps after resting,
* Having a Roles and Maudsley score of 3 or 4 in the initial evaluation

Exclusion Criteria:

* Having a body mass index greater than 30 kg/m2,
* Having any cardiopulmonary, dermatological, neurological or orthopedic problems other than plantar fasciitis,
* Having a history of foot or ankle surgery,
* Using an assistive device (walker, canadiens, etc.)
* Not using appropriate shoes,
* Having cognitive, mental and/or psychological problems
* Being pregnant
Smoking Cessation Study

This is a pilot study to determine the feasibility and success of offering smoking cessation counseling for ambulatory patients who present for scheduled cardiac catheterization.

This is a prospective randomized pilot study of feasibility and success of smoking cessation counselling for ambulatory patients who present for scheduled cardiac catheterization. Patients who meet inclusion and exclusion criteria will be eligible for enrollment and receive smoking cessation counseling. Patients will be followed for 6 months post intervention. A Usual care arm will be created using retrospective chart review.

Eligibility Criteria:
Inclusion Criteria:

* Presents to Dartmouth-Hitchcock Medical Center in Lebanon, NH as an ambulatory patient with a scheduled cardiac Catheterization
* smoke one or more cigarettes per day for the past 12 months OR use of electronic-cigarettes containing tobacco at least once during the past 30 days.
* proficient in English

Exclusion Criteria:

* N/A
Italian iTTP Registry

ItaliTTP is an observational, prospective, single-arm, national, multicenter, non-pharmacological cohort study aimed at better defining and understanding the natural history, disease severity, and clinical outcomes of patients with immune-mediated thrombotic thrombocytopenic purpura (iTTP) in Italy.

A minimum of 132 consecutive patients with acute iTTP (first event or relapse) will be enrolled for 3 years, with the possibility of extension, with a follow-up period of 3 years.

Acquired immune-mediated thrombotic thrombocytopenic purpura (iTTP) is a rare, life-threatening thrombotic microangiopathy characterized by episodes of thrombocytopenia, microangiopathic hemolytic anemia, and extensive microvascular thrombosis leading to multiorgan involvement. Despite advances in understanding iTTP etiology and management in the acute phase, significant gaps in knowledge about its progression, particularly during clinical remission and concerning long-term complications, persist.

ItaliTTP, a national, multicenter, observational, prospective, non-pharmacological cohort study, aims to elucidate the natural history, severity, and outcomes of iTTP in Italy. The study will enroll hospitalized iTTP patients (experiencing either initial or recurrent episodes) and follow them in outpatient settings across participating Italian centers. The study plans to include at least 132 patients of any gender, aged 12 to 99, over a three-year period, with an option for extension, and a three-year follow-up. During hospitalization and subsequent outpatient visits, participants will undergo routine clinical assessments and laboratory tests. In addition to these data, peripheral blood samples will be collected for ADAMTS13 analysis and potential future research.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an acute iTTP episode (first event or relapse), defined by thrombocytopenia and microangiopathic hemolytic anemia, in the absence of alternative causes, and the presence of severe deficiency of ADAMTS13 activity (\< 10 IU/dL or \<10% of normal value) and anti-ADAMTS13 autoantibodies
* Both male and female patients, aged 12 years or older
* Patients who have signed the informed consent for the participation to the study

Exclusion Criteria:

* Patients who have not signed the informed consent for the participation to the study
Prospective Randomized Clinical Trial of Intravenous Lipids and Cholestasis

The Investigators hypothesize that increased cumulative amount of lipid intake causes PNAC in late preterm and term neonates with major GI surgical disorders


Eligibility Criteria:
Inclusion Criteria:

All neonates ≥ 34 weeks gestational age with major GI surgical disorders (Gastroschisis, omphalocele, volvulus, trachea-esophageal fistula, duodenal atresia, jejunal atresia, ileal atresia, hirschsprung's disease, anorectal malformation, intestinal obstruction, and GI perforations) requiring surgery admitted to our NICU within first 72 hours will be eligible for this study

Exclusion Criteria:

1. If does not need TPN by 72 hours;
2. Direct hyperbilirubinemia within the first 72 hours after birth;
3. TORCH infections (Toxoplasmosis, CMV, Herpes, Rubella, HIV, etc);
4. Biliary tract disorders leading to direct hyperbilirubinemia;
5. Known metabolic disorders that may be associated with direct hyperbilirubinemia- such as Galactosemia, α-1 antitrypsin deficiency, etc
The Effect of Fish Oil in Major Depressive Disorder

The whole study was divided into two major parts: (A) the 12-week, double-blind, randomized controlled, parallel omega-3 fatty acid monotherapy study in 60 patients with mild to moderate major depressive disorder. (B) The double-blind, randomized controlled, parallel omega-3 fatty acid add-on prevention study in 60 patients with major depressive disorder in recovery status.

The goals of this study were to examine the therapeutic and recurrence prevention effects of omega-3 fatty acids on major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

1. DSM-IV criteria for major depressive disorder.
2. Age being age 18-65.
3. Capacity and willingness to give written informed consent.

Exclusion Criteria:

1. Any major medical illnesses.
2. A recent or past history of any Axis-I diagnoses besides major depressive disorder, including psychotic disorders; cognitively impaired mental disorders; impulse control disorders; substance use disorder or substance abuse (last 6 months prior to the studies); primary anxiety disorders, including post-traumatic stress disorder and panic disorder; and bipolar disorders; or Axis-II diagnoses, i.e. borderline and antisocial personality disorder.
Cognitive Training for Post Traumatic Stress Disorder: Effects on Cognitive, Emotional, and Brain Function

The purpose of this pilot study is to determine the effects of computer-based training in executive functioning compared to word games on cognitive and emotional aspects of combat-related PTSD.

Many posttraumatic stress disorder (PTSD) patients either choose not to complete or do not achieve optimal response to current first-line behavioral and pharmacologic treatments. Neurocognitive research points to the potential of novel treatments targeting dorsal prefrontal function and inhibition, attention, and working memory processes. This study investigates effects of computer-based training in executive functions compared to word games on cognitive and emotional aspects of combat-related PTSD. Paper-and-pencil questionnaires, interviews, computer-administered testing, and magnetic resonance imaging will be complete before and after the intervention. Results from this pilot study will provide information concerning feasibility and treatment potential of cognitive training for PTSD.

Eligibility Criteria:
Inclusion Criteria:

* combat veterans who served in Operation Iraqi Freedom, Operation Enduring Freedom, or Operation New Dawn

Exclusion Criteria:

* enrolled in other active treatment protocols
* current substance abuse or dependence
* current suicidal ideation
* diagnosis of a neurological disorder
* history of moderate to severe traumatic brain injury
The Impact of Chiropractic on Long COVID-19

The purpose of this waitlist-controlled, single-blind, one-way crossover, pilot trial is to evaluate the potential effects of \~8 weeks of chiropractic care on patient-reported fatigue and the autonomic nervous system in adults with long COVID. This study will allow us to estimate the standard deviation of the primary endpoint in our population with which a formal power calculation for a future randomized, controlled trial can be performed.

After providing informed consent, participants will be placed on an 8-week waitlist followed by 8 weeks of chiropractic care. In-person assessments will occur 5 times: Day 1, following 2-3 weeks on waitlist, following 8 weeks on waitlist, following 2-3 weeks of chiropractic care, and following 8 weeks of chiropractic care. Patient-reported outcomes will additionally be sent prior to the first in-person assessment (Day 0).

Assessments will include the following:

1. Seated resting recording
2. Sit-to-stand test
3. Patient-reported outcome surveys

Each assessment will consist of the following recordings:

1. Electroencephalography \[EEG\]
2. Impedance cardiography \[ICG\]
3. Electrocardiogram \[ECG\]

Eligibility Criteria:
Participants will be individuals between the age of 18 and 65 who have tested positive for a COVID-19 viral infection, or SARS-CoV-2 antibodies, not less than 120 days prior to their enrollment in the study. Participants may also qualify if they have been medically diagnosed with long-COVID by their medical provider, regardless of a positive test result. They must have a T score greater than or equal to 55 on the FACIT Fatigue survey. They must also present with at least 1 of the following symptoms that cannot be explained by an alternative diagnosis, with symptom onset or exacerbation after contraction of COVID-19.

* Body aches/joint pain
* Shortness of breath or difficulty breathing
* Persistent chest pain or pressure
* Recurrent fever, chills or night sweats
* Headache or dizziness
* Difficulty concentrating or focusing
* Memory problems
* Sleep problems
* Anxiety or depression
* Heart palpitations or tachycardia
Psoriatic Inflammation Markers Predictive of Response to Adalimumab

The objective is to compare the initial skin inflammatory transcriptomic profile of psoriatic patient responder to Adalimumab therapy (defined as the achievement of a Psoriasis Area and Severity Index 75 response at 16 weeks) with the transcriptomic profile of patient non-responder to Adalimumab therapy (defined as the non-achievement of a Psoriasis Area and Severity Index 50 response at 16 weeks) to identify differentially expressed genes in order to define predictive markers of response to the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Chronic plaque psoriasis involving at least 10% of body surface area, with a PASI score \>10,
* Negative pregnancy test for women of childbearing potential, and use of an effective method of contraception,
* Pretreatment assessment to identify contraindications to anti-tumor necrosis factor-alpha therapy (chest x-ray and Intradermal reaction (detection of latent tuberculosis),
* Anti-tumor necrosis factor-alpha treatment with adalimumab has been prescribed

Exclusion Criteria:

* Classical exclusion criteria for adalimumab therapy (hypersensitivity to the product, severe heart failure, abscess, tuberculosis or other opportunistic infection),
* History of demyelinating disease, any unstable medical condition, patients with recurrent serious infections , history of cardiovascular or cerebrovascular disease , history of cancer
* Patients not having tuberculosis prophylaxis as per local guidelines for latent tuberculosis, or patients non-treated active tuberculosis
* Ongoing pregnancy or breastfeeding
* Absence of written consent,
* Prior treatment with one of the following anti-psoriatic treatments: biologics during the 3 months prior baseline visit, other systemic treatment during the 4 weeks prior baseline visit or topical therapy during the 2 weeks prior baseline visit.