cyrilzakka/clinical-trials huggingface dataset:
Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh

The intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair.

The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.


Eligibility Criteria:
Inclusion Criteria:

* Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2)
* First repair
* Older than 35 years of age and younger than 75 years of age
* Both genders
* Any BMI
* Only upper abdominal midline incisional hernias (supraumbilical)
* Patients submitted only to elective repair

Exclusion Criteria:

* Recurrent incisional hernia
* Emergency surgery
* Hernias with a diameter higher than 5 cm or more than 25 cm2 of area
* Lower midline abdominal incisional hernias
* Other hernias rather than midline incisional hernias
* Non-incisional hernias
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants

This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of BIIB091 in healthy participants.This study will also determine the effect of food on the single oral dose pharmacokinetic (PK).

Initial protocol recruitment and follow up was completed by 10 Jan 2020 with an optional cohort intended for completion by April 2020. Subsequently, a decision was made not to progress this optional cohort in light of COVID-19 which has resulted in a delay in reporting the actual completion date.

Eligibility Criteria:
Key Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with applicable participant privacy regulations.
* Have a body mass index between 18 and 30 kg/m2, inclusive.
* All male participants must practice highly effective methods of contraception and not donate sperm during the study and for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
* All female participants of childbearing potential must practice highly effective methods of contraception and not donate eggs during the study and for at least 90 days after their last dose of study treatment.
* Must be in good health as by the Investigator, based on medical history and screening evaluations.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic,hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* History of severe allergic or anaphylactic reactions, or of any allergic reactions that in the opinion of the Investigator are likely to be exacerbated by any component of the study treatment.
* History of, or ongoing, malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to Check-in).
* Current enrollment or plan to enroll in any other drug, biological, device, or clinical study, or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Check-in, or 5 half-lives of the drug or therapy, whichever is longer.
* Breastfeeding, pregnant, or planning to become pregnant during study participation.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of an Ascensia Lancing System

The purpose of this study was to determine if untrained subjects with diabetes could perform basic tasks with the Styx lancing device to obtain adequate blood volume from fingerstick and palm lancings for Blood Glucose Meter testing.


Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years of age and older
* People with type 1 or type 2 diabetes
* People who regularly perform self-tests (at least once/day) with their own lancing device
* Able to speak, read, and understand English
* Willing to complete all study procedures

Exclusion Criteria:

* Those with missing tips of the fingers indicated in the protocol or physically unable to lance the palm areas and all the fingers indicated in the protocol.
* Hemophilia or any other bleeding disorder
* Pregnancy
* Physical, visual or neurological impairments that would make the person unable to perform testing
* Persons who have used the Styx device in a previous clinical evaluation
* Working for a competitive medical device company, or having an immediate family member who works for such a company
* A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
Evaluation of the Efficacy and Safety of Insulin Detemir Compared With That of NPH Insulin in Subjects With Type 1 Diabetes.

The aim of this trial is to evaluate the efficacy and safety of insulin detemir using the 2400 nmol/mL formulation to optimise dosing in subjects with type 1 diabetes on a basal (once daily)-bolus regimen.


Eligibility Criteria:
Inclusion Criteria:

* Signed and dated informed consent obtained before any trial-related activities
* Type 1 diabetes diagnosed and classified according to aetiology
* Duration of type 1 diabetes equal to or more than 12 months
* Glycosylated haemoglobin less than or equal to 12 percent based on analysis from central laboratory
* Able and willing to perform self-blood glucose monitoring

Exclusion Criteria:

* Proliferative retinopathy
* Total basal insulin dose of more than 100 IU per day
* Recurrent major hypoglycaemia - that would interfere with trial participation (as judged by the investigator)
* Known unawareness of hypoglycaemia
* Previous treatment with insulin detemir
Dry Needling for Cervicogenic Headache

This is a single-blinded randomized clinical trial. The primary aim of this study is to compare the effectiveness of dry needling of myofascial trigger points in the muscles of the head and cervical spine in addition to an upper extremity strengthening/stretching exercise program compared to a dry needling group alone on pain scores, cervical range of motion, pain sensitivity and changes in severity and frequency of pain symptoms in individuals with cervicogenic headache.

This is a single-blinded randomized clinical trial. Eligible participants who agree to enroll in the study will be asked to attend four testing sessions. Participants in both groups will receive dry needling to the involved head and cervical muscles and the other group, in addition to receiving a dry needling intervention, will be instructed in a standard home exercise program consisting of strengthening and stretching exercises for the upper quarter. All dry needling (using standard clean technique) will be performed by licensed physical therapists board certified in orthopaedic physical therapy and having a minimum of 5 years of experience treating patient populations with dry needling.

The aim of this research study is to compare he effectiveness of dry needling alone with dry needling and a home exercise program on pain, pain sensitivity, cervical range of motion, and changes in the severity and frequency among individuals with headache symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral headache (HA) without side shift
* H/o pain triggered by neck movement
* Limitation in cervical range of motion
* Ispilateral neck, shoulder or arm pain
* Intermittent pain with episodes varying in duration
* Head and neck pain is non-throbbing in nature

Exclusion Criteria:

* Use of anti-coagulation medicine (except low dose aspirin)
* Pregnancy
* Acute or uncontrolled medical illness
* Opioid use within six months
* Fibromyalgia or diffuse painful syndromes in the UE or LE
* Substance abuse
* Presence of fever, vomiting or visual changes
Anti-Inflammatory Milk Matrix

Obesity is pro-inflammatory, impairs metabolism, and physically limiting. Specifically, muscle in obese persons does not synthesize proteins normally. This further increases metabolic and physical dysfunction. As such, obesity programs should not only focus on weight loss, but muscle metabolic health. Dairy nutrients have anti-inflammatory and anabolic properties, but mostly evaluated in isolation and/or pre-clinical designs. Also, it is unknown if the circulating benefits extend to the muscle. We hypothesize that dairy full-fat milk will improve these obesity characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Obese (BMI, body mass index ≥30, \<40 kg•m-2)
* Age 40-59
* Pre-menopausal
* Sedentary/insufficiently active for prior 6 months (mo)
* Weight stable for prior 6 mo

Exclusion Criteria:

* Tobacco, nicotine (patch/gum) use (previous 6 mo)
* Alcohol consumption \>10 drinks per week
* Metabolic disorders (e.g., Metabolic Syndrome, Diabetes, thyroid diseases)
* Cardiovascular disease, arrhythmias
* Hypogonadism
* Asthma
* History of uncontrolled hypertension
* Orthopedic injury/surgery (within 1 yr)
* Hepatorenal, musculoskeletal, autoimmune, or neurological disease
* History of neuromuscular problems
* Previous participation in amino acid tracer studies
* Predisposition to hypertrophic scarring or keloid formation
* Consumption of ergogenic-levels of dietary supplements that may affect muscle mass (e.g., creatine, HMB), insulin-like substances, or anabolic/catabolic pro-hormones (e.g., DHEA) within 6 weeks prior to participation
* Consumption of thyroid, androgenic, or other medications known to affect endocrine function
* Consumption of medications known to affect protein metabolism (e.g., prescription-strength corticosteroids, non-steroidal anti-inflammatories, or acne medication)
* Pregnancy
* Allergy to dairy product or lactose intolerance
* Fasting plasma glucose (FPG) ≥ 126 mg/dL
* Oral glucose tolerance test (OGTT) ≥ 200 mg/dL
Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas

Objective:

The aim of this study is to investigate whether Crohn's Disease patients with peri-anal fistulas will suffer from sexual dysfunction in an attempt to help us identify Crohn's Disease patients that would benefit from sexual health interventions.

Hypothesis:

Crohn's patients with active perianal fistulas will have decreased sexual drive, performance, and satisfaction than those with Crohn's Disease in remission.

Subject Selection:

Inclusion Criteria Patients in a stable sexual relationship between the ages of 19 and 70 of both sexes with Crohn's disease, as diagnosed based on clinical, radiological, endoscopic or histopathological criteria for a minimum of 6 months will be included in this study. Patients included in this study will have been sexually active in the last 4 weeks.

Exclusion Criteria All patients with known depression will be excluded from the study to prevent confounding the findings.

Patients that qualify for the study will be recruited, and be divided into inactive Crohn's Disease group with no peri-anal fistulas as a control group and an active Crohn's Disease with peri-anal fistula as the study group. Inactive Crohn's Disease patients will be defined as patients with Harvey-Bradshaw scores below 5. Fistula patients will be defined as patients with single or multiple draining fistulas, including perianal fistulas and enterocutaneous fistulas, for at least three months (17).

Eligibility Criteria:
Inclusion Criteria:

* patients in a stable sexual relationship between 19-70 years old with Crohn's Disease
* Crohn's disease diagnosis is based on clinical, radiological, endoscopic or histopathological criteria for a minimum of 6 months
* Patients will have been sexually active in the last 4 weeks.

Exclusion Criteria:

* All patients with known depression will be excluded from the study to prevent confounding the findings.
Google Trends of Global Surgery

Introduction Global surgery is a growing movement worldwide, but its expansion has not been quantified. Google Search is the most popular search engine worldwide, and Google Trends analyzes its queries to determine popularity trends. The investigators used Google Trends to analyze the regional and temporal popularity of global surgery (GS). Furthermore, the investigators compared GS with global health (GH) to understand if the two were correlated.

Methods The investigators searched the terms "global surgery" and "global health" on Google Trends (Google Inc., CA, USA) from January 2004 to May 2021. The investigators identified time trends and compared the two search terms using SPSS v26 (IBM, WA, USA) to run summary descriptive analyses and Wilcoxon rank-sum tests.


Eligibility Criteria:
Inclusion Criteria:

* Data point from Google Trends concerning Global Surgery
* Data point from Google Trends concerning Global Health
* Data point from Google Trends between January 2004 and May 2021

Exclusion Criteria:

* Data point from Google Trends before January 2004
* Data point from Google Trends after May 2021
* Data point from Google Trends outside the scope of Global Surgery or Global Health
Evaluation of the Relationship Between Mediterranean Diet and Menopausal Symptoms in Postmenopausal Women

This cross-sectional study aimed to evaluate the relationship between the frequency and severity of postmenopausal symptoms in women aged 45-65 years and the level of compliance with the Mediterranean diet, and the main question it aimed to answer is: Do women with higher compliance with the Mediterranean diet have milder symptoms?

This cross-sectional study was conducted between 01.01.2024 and 01.06.2024 with women aged 45-65 who were registered at Tuzla E-ASM affiliated with Marmara University Pendik Hospital and who had been in menopause for at least 1 year. The sample size was calculated as 272 and the target number was determined as 305. After obtaining written consent from the participants who agreed to participate in the study and met the inclusion criteria, a questionnaire form was applied to these individuals, which questioned their sociodemographic characteristics, age of menstruation onset, pregnancy history, smoking and alcohol use, use of supplements, Mediterranean Diet Adherence Scale (MEDAS) and Menopause Rating Scale (MRS). The presence, type and severity of menopausal symptoms with the Mediterranean diet were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Those who volunteered to participate in the study,

Exclusion Criteria:

* Those with a diagnosed eating disorder,
* Those using medication for obesity,
* Those with a chronic metabolic disease that is not receiving treatment and whose values related to the disease are not regulated (pronounced hypo/hyperthyroidism, uncontrolled diabetes, etc.),
* Those with a mental or physical condition that prevents communication (some neuropsychiatric diseases and mental retardation),
* Those who do not understand and/or speak Turkish,
* Those who do not give consent to participate in the study, •-Those who are currently using any hormonal supplements to prevent or reduce menopausal symptoms were excluded from the study.
Steno Tech Explore: A Study of Insulin Pump Users With Type 1 Diabetes

The present study is part of an overarching study being conducted in Denmark at Steno Diabetes Center Copenhagen (SDCC) and Nordsjællands Hospital Hillerød (NOH), Steno Tech, that aims to develop and ultimately, in a randomized controlled trial (RCT), test approaches that can assist people with type 1 diabetes in obtaining optimal outcomes using CSII. Through a large-scale, questionnaire-based online survey enriched with data from national registers, this sub-study contributes to this overarching aim by exploring the importance of individual differences across a wide range of factors, including demographic, socioeconomic, health status, psychosocial and preference structures, for optimal use of CSII in people with type 1 diabetes.

See attached protocol for a detailed description.

Eligibility Criteria:
The Steno Tech Survey Repondents group:

* Adult (18+ years)
* Type 1 diabetes
* Insulin pump user
* Danish-speaking

The General Type 1 Population group:

* Adult (18+ years)
* Type 1 diabetes
Clinical and Radiographic Success of Nusmile Bioflex Versus Stainless-Steel Crowns in Restoring Decayed Primary Molars with Modified Hall Technique

This pilot study aims to compare the clinical and radiographic success of Bioflex (Nusmile) crowns Versus Stainless-steel crowns in restoring decayed primary molars.

Decayed primary teeth must be treated promptly because they are crucial for chewing, speaking, and holding the space for permanent teeth. Losing primary teeth too early can cause various issues, including psychological problems. Hence, restoring decayed primary teeth is an essential aspect of pediatric dentistry Preformed metal crowns are a popular and affordable option as a treatment for dental caries. They offer full crown coverage and help to prevent recurrent caries. However, their aesthetic limitation is a notable drawback Parents are increasingly concerned about the appearance of dental restorations for their children and prefer tooth-colored options. To overcome this issue, Nusmile has introduced a new type of crown called "Bioflex". These crowns combine the best qualities of both stainless steel and zirconia crowns, as they are flexible, adaptable, and durable

Eligibility Criteria:
Inclusion Criteria:

* Clinical Criteria:

  1. Children from age 4-7.
  2. Cooperative children and willing for follow-up visits.
  3. Mandibular second Primary molars with multi-surface caries
* Radiographic criteria:

  1. Mandibular second Primary molars with at least two-thirds of the root remaining.

     Exclusion Criteria:
     * • General Criteria:

  <!-- -->

  1. •Unable to attend follow-up visits
  2. •Refuse to participate in the study
  3. •Uncooperative child
* Clinical Criteria:

  1. • Tooth with grade II or grade III mobility
  2. •Children with bruxism
  3. • Pulpally involved teeth
* Radiographic Criteria:

  1. •Tooth with pathological root resorption
  2. •Teeth with root caries
Effects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease.

This RCT study is designed to examine the extent to which L. plantarum PS128 can improve symptoms in PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with PD will receive PS128 or placebo intervention for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.

This RCT study is designed to examine the extent to which L. plantarum PS128 can improve symptoms in PD patients. L. plantarum PS128 is a psychobiotic that regulates the level of dopamine in specific brain regions. Patients with PD will receive PS128 or placebo intervention for 12 weeks. Symptoms of PD will be clinically evaluated before and after the treatment, and the results will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Modified Hoehn \&Yahr stage, MHY 1-3
* 45-80 years old
* at least 9 years education

Exclusion Criteria:

* Patients on antibiotics within the preceding one month
* Patients using of other probiotic products (sachet, capsule or tablet) within the preceding two weeks
* Have undergone surgery of liver, bladder, or gastrointestinal tract
* Have current or history of inflammatory bowel disease
* Have history of cancer
* Known allergy to probiotics
* Patients with comorbid dementia (Mini-Mental State Examination score ≤ 26) or major depression (The Beck Depression Inventory-II score ≥ 29)
* Have received deep brain stimulation
* Patients receiving artificial enteral or intravenous nutrition
* Diagnosed before 40 years old
* Poor control of other chronic diseases
* Not eligible judged by PI
Pembrolizumab Combined With Double Platinum Based Chemotherapy for Potentially Resectable NSCLC

This study aims to explore the efficacy and safety of Pembrolizumab Combined With Double Platinum-Based Chemotherapy for Potentially Resectable Non-driver Gene Mutation Non-small Cell Lung Cancer

Inclusion criteria:

diagnosed with Non-small cell lung cancer EGFR and ALK and ROS1 negative Treatment naive Potentially Resectable identified by MDT

Eligibility Criteria:
Inclusion Criteria:

* ≥18，Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
* Potentially Resectable NSCLC
* Treatment Plan is Crizotinb or Standard Chemotherapy

Exclusion Criteria:

* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women
ChitoCare Medical Wound Healing Gel PMCF Study on Healing of Chronic Wounds

We are testing a gel intended for the protection and healing of chronic wounds as a support for standard therapy. The main component of the gel is chitosan, a natural polymer that has the ability to stop bleeding, has a positive effect on wound healing, and has antimicrobial properties.

The purpose of this PMCF study is to evaluate the safety and efficacy of ChitoCare medical Wound Healing Gel for the healing of chronic wounds. The study will enroll patients with diabetic foot ulcer, venous ulcer or pressure ulcer. Patients will be randomly assigned to an active or control group. The active group will apply the gel to the wound, in addition to the standard of care, while the control group will receive only standard care. The study will last from 3 to 18 months for an individual patient (15-month recruitment period and 3 months of follow-up after the last patient is enrolled) or until event occurrence (complete wound healing/exclusion from the study). The study envisages four visits: Visit 1 - Screening and Inclusion visit, Visit 2 (after 4 weeks), Visit 3 (after 12 weeks) and Visit 4 - End of Study Visit: The final visit will take place when the event occurs (complete healing/exclusion from study). On each visit, the patients will have their wound photographed and assessed after debridement. Adverse events will be followed throughout the whole study.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be given
2. Patient ≥ 18 years old
3. Presence of chronic wound (Wagner grade I and II diabetic foot ulcer, venous leg ulcer or pressure ulcer) that meets the following criteria:

   * Size of the wound ≥ 0.5 cm2
   * Wound is not infected at the time of randomization
   * Wound is present for at least 4 weeks
4. Able to understand and comply with the requirements of the study

Exclusion Criteria:

1. Patients with serious concomitant disease (cancer, heart failure (NYHA class IV), severe anaemia (Hb\<100 g/L), neoplasia)
2. Any significant condition that may preclude the participant from the study (e.g. severe depression or psychiatric illness)
3. Patients that will require surgical procedure to treat their ischemic condition on the limb where the wound is present as assessed by the investigator
4. Patients diagnosed with autoimmune connective tissue diseases
5. Previous treatment under this clinical protocol
6. Participation in another clinical trial
7. Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
8. Allergy to shellfish (for active study group)
9. Medical condition likely to require systemic corticosteroids during the study period
10. Pregnant and lactating women