cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Two Types of Meshes Used in Pelvic Organs Prolapse Procedures

Using partially absorbed meshes in pelvic reconstructive surgery will involve fewer postoperative complications especially less pain caused by the mesh mass.

Weakness of pelvic floor support is the cause defects and damage to pelvic organs functioning and urinary control and it has a pretty common occurrence. It was suggested recently that the event is considered a hernia that requires mesh use, which reduces return rates following pelvic floor repair. Mesh use is known to cause complications and unwanted side effects, such as chronic pain, vaginal network exposure and infection. The degree of complications is related directly to the mass of the mesh, and that's why the absorbable meshes were developed.Two months after the surgery with absorbable mesh, the mass left in the patient's body is half of the initial mesh mass and according to our assumption this effect will minimize the extent and intensity of mesh complications compared with conventional ones.

During the study we will examine medical records of women who have had surgery with pelvic floor reconstructive meshes. The cases will be divided according to the mesh type being used.

A polypropylene mesh (single strand and tunneling wide) trade name "Prolift", and similar mesh that contains approximately half of the network mass after being dissolves in two months, a trade name "Prolift +" M.

The number of participants in each group is 120 women. The post-operative follow-up examination will include three points in time. After a month, six months and a year later. In addition to questionnaires in order to quantify the degree of urinary disturbance, pain after surgery and sexual function.

Eligibility Criteria:
Inclusion Criteria:

* Women who had pelvic floor repair surgery wit mesh used to the posterior vaginal wall.

Exclusion Criteria:

* Women with significant pre-operative pain
* Women with collagen diseases
* Women who underwent pelvic floor repair surgery with mesh to the anterior vaginal wall
Effects of Aerobic and Resistance Training on Abdominal Fat Loss

Study the effects of different exercise modes on total and regional adiposity variation in subcutaneous and visceral adipose tissue (VAT and SAT). The investigators hypothesize that total abdominal will improve for all the exercise groups compared to the control group. When comparing intervention groups: 1) no differences on the degree of improvement in total abdominal fat depots (VAT and SAT) 2) different degree of change when comparing specific sections at VAT and SAT are expected.


Eligibility Criteria:
Inclusion Criteria:

* 30 - 39.9 kg/m2 BMI
* White/Caucasian
* Female
* Sedentary

Exclusion Criteria:

* Known cardiovascular, pulmonary, metabolic disease
* Pregnant females
* Any excluded criteria with MRI scans (i.e. certain metal implants, recent tattoos)
* Diabetic
* Hypertension
* Cigarette smoking
* MRI related contraindications (metal, no removable devices, etc.)
Pain Severity in Flapless Dental Implant Placement Using Laser

The goal of this split-mouth randomized clinical trial study was to investigate the effect of using a laser on pain and discomfort following flapless dental implant surgery. It was hypothesized that laser did not have any impact on post-op pain. Therefore, the study aimed to compare pain and discomfort following flapless dental implant surgeries with or without a laser.


Eligibility Criteria:
Inclusion Criteria:

1. Adult human subjects agreed to participate in the study and return on follow-up times
2. Subjects eligible for receiving dental implants
3. Subjects with an edentulous area in the posterior of the mandible bilaterally 3- Subjects with sufficient bone width and height (\>5 mm width, and \>10 mm height) at the implant sites
4. Subjects with sufficient keratinization tissue at the implant sites

Exclusion Criteria:

1. Subjects refused to return for follow-up or refused study enrollment.
2. Subjects with uncontrolled systemic diseases
3. Subjects younger than 18 years
4. Subjects receiving psychotropic drugs
Impact of Mindful Self-Compassion Therapy on Self Harm Behaviors, Emotional Regulation and Quality of Life Among Patients With Borderline Personality Disorder

The primary purpose of the study is to investigate whether Mindful Self-Compassion (MSC) therapy can significantly reduce self-harm behaviors, improve emotional regulation, and enhance the quality of life in individuals diagnosed with Borderline Personality Disorder (BPD). The study aims to contribute to the existing literature by providing robust evidence on the efficacy of MSC therapy for BPD, which could inform clinical practices and improve treatment outcomes

The current quantitative study will be carried out in two phases. A cross-sectional survey will assess quality of life, emotional regulation, psychological distress, self-harm behaviors, social support, and state of mindfulness during the first phase. A randomized controlled trial (RCT) will be done during the second phase where patients with Borderline Personality Disorder who are identified with psychological distress, low level of social support, and quality of life, will be categorized into two groups i.e. waitlist control group and intervention group through the process of randomization. Then Mindful Self Compassion therapy would be applied to participants in the intervention group. The control group is the waitlist control group so initially no intervention will be given to participants in the control group but the intervention will be given to the control group participants once the study is completed. The Mindful Self Compassion therapy would be implemented on participants using individual and in-person modes. The pre-and post-assessment will be done at Times 1 and 2 within and between control and interventional groups. After doing post-assessment the difference between pre and post-assessment will be compared to explore the efficacy of Mindful Self Compassion Therapy in patients with borderline personality.

Eligibility Criteria:
Inclusion Criteria:

* 1. First time diagnosed non-hospitalized patients of Borderline Personality Disorder.

  2. Patients of Borderline Personality Disorder experiencing psychological distress,low level of quality of life, social support, emotional dysregulation would be included.

  3. Borderline Personality Disorder patients with age 18 years and above (both gender) from outpatient department (OPD) 4. Borderline personality patients who would be able to understand Urdu language and can give the informed consent
* Exclusion criteria

The study would have the following exclusion criteria:

1. Hospitalized patients of Borderline Personality
2. Patients with Borderline Personality having other chronic co-morbid diseases such as cancer, cognitive deficits, and other chronic psychological disorders.
3. Patients with Borderline Personality younger than 18 years of age
A Long-term Safety Study of Infliximab (Remicade)

This is a study evaluating the long-term safety of infliximab (Remicade)

The purpose of this study is to collect long-term safety information on infliximab (Remicade) from patients who participate in research studies using those drugs. All patients in these studies are being asked to participate in this long-term safety follow-up study which will provide important information about the study drug. The long-term effect of the study drug on survival, serious infections, new malignancies and new autoimmune diseases will be measured from data collected over a 5-year period. Additional information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if you received infliximab (Remicade) after the end of the primary study. Study participation in this research study is 5 years after the end of the primary study. Questionnaires will be completed about patient's health and the occurrence of these safety events at intervals of 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after patients complete participation in the primary study.

Eligibility Criteria:
Inclusion Criteria:

* All patients enrolled in ongoing and future Centocor sponsored infliximab clinical studies that require long-term safety follow-up (ie, primary studies). Patients must have received at least 1 dose of study agent to be eligible for participation in the study

Exclusion Criteria:

- Did not previously participate in Centocor sponsored infliximab clinical studies.
Assess the Impact of Lip Rejuvenation on Projected First Impressions and Mood Perceptions

20 subjects with mild to severe oral commissures or none to severe perioral lines will be enrolled and injected with Restylane® Silk. Photographs will be taken prior to and 14 days after Optimal Cosmetic Results has been achieved, as judged by the investigator.

Changes in the projected first impression will be assessed by a total of 200 blinded evaluators rating the photographs of subjects from the baseline and from 14 days post achieving the Optimal Cosmetic Results. Changes in subjects' mood will be self-assessed through Subjective Happiness Scale and Happiness Measures questionnaires. Aesthetic alterations will be assessed by the investigator via the Global Aesthetic Improvement Scale, Oral Commissure Severity Scale, and the Perioral Lines Severity Scale as well as by the self-assessment of subjects using the Global Aesthetic Improvement Scale.


Eligibility Criteria:
Inclusion Criteria:

* Subject is an adult of at least 21 years of age;
* Subject has mild to severe oral commissures or none to severe perioral lines, as assessed by the treating investigator;
* Subject is willing and able to provide written informed consent prior to the performance of any study related procedure;
* Subject is willing and able to comply with the protocol requirements; and
* Subject is willing and able to provide written photo consent and adhere to the photography and video procedures such as removal of jewelry and makeup

Exclusion Criteria:

* Subjects who have received lip filler treatments in the past 12 months or neurotoxin injections in the past 6 months;
* Subjects who plan to undergo neurotoxin treatments, ablative skin treatments, facial cosmetic surgery, or other injectable filler treatments during the course of the study;
* Subjects with a known allergy or sensitivity to any component of the study ingredients;
* Subjects with a history of bleeding disorders;
* Female subjects who are pregnant or nursing as well as those who are of childbearing potential but do not employ adequate birth control methods;
* Subjects with severe allergies manifested by a history of anaphylaxis or presence of multiple severe allergies;
* Subjects with previous history of sensitivity to amide type local anesthetics;
* Current history of chronic drug or alcohol abuse;
* Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study product;
* Subjects who, in the investigator's opinion, have a history of poor cooperation, non-compliance with medical treatment, or unreliability; and
* Enrollment in any active study involving the use of investigational devices or drugs.
Virtual Walking Intervention for Neuropathic Pain in Spinal Cord Injury

The purpose of this study is to determine if playing a virtual reality walking game can help improve neuropathic pain in adults with chronic spinal cord injury.

Many people with SCI experience neuropathic pain. Neuropathic pain is often described as sharp, burning, or electric. 'Traditional' treatments often do not do a good job of reducing neuropathic pain. Therefore, it is important to see if 'non-traditional' treatments might work. Scientists think that neuropathic pain occurs in SCI because the sensations coming from the eyes and up the spinal cord to the brain do not match what the brain thinks it told the body to do. This 'mis-match' may result in changes in the brain that make neuropathic pain possible. Virtual reality walking reduces this 'mis-match.' It does this by creating the 'illusion' that the person is walking. The brain then thinks it is telling the body to walk AND the information coming from the eyes matches its instructions. This 'matching' may reverse the brain changes that made neuropathic pain possible. The current study is specifically focused on individuals whose SCI has been classified as complete (ASIA A).

Eligibility Criteria:
Inclusion Criteria:

The study will recruit individuals with complete injury (American Spinal Injury Association \[ASIA\] classification A) with lumbar, paraplegic, or low tetraplegic (C5-C7) injury. Additional criteria will include:

1. Must have persistent NP symptoms that are of daily severity of at least 4/10 for 3 or more months
2. Must endorse more than 2 items on a 7-item Spinal Cord Injury Pain Instrument, SCIPI
3. Must be 18 years of age or older
4. Must be more than one year post-injury to begin study (can be screened at an earlier time for eligibility)
5. Must have mobile connectivity with usable service
6. Must be stable on pain medication for 1 or more months
7. Must be cleared on the VRWalk physical activity clearance scale
8. Must not have motion sickness that interferes with daily life

Exclusion Criteria:

1. Individuals with Injury levels between C1 and C4
2. Individuals under the age of 18
3. Individuals who were injured within the past year
4. Individuals who cannot comprehend spoken English
5. Individuals who are in prison
6. Individuals who are blind
7. Individuals who experience severe motion sickness
Increasing Donor Designation Rates in Teenagers: Effectiveness of a Driver's Education Intervention

Four aims were pursued: (1) Evaluate the effectiveness of video messaging on adolescent donor designations in comparison to a regionally-matched historical comparison group of adolescents; (2) Compare the differential effectiveness of three commonly-used donation messaging strategies (informational, testimonial, and blended) on donor designations; (3) Examine the impact of donation messaging on changes in secondary outcomes (donation engagement, knowledge, attitudes, beliefs, likelihood of donor designation, discussion with a parent) before and after video intervention; and (4) Assess the commitment of parents to follow their adolescent's donation wishes in the event of death. Our central hypotheses were that integrating donation video messaging into driver education classes would generate a higher proportion of donor designations compared to a historical comparison group and that blended video messaging (informational + testimonials) would yield a higher proportion of donor designations and more change in secondary outcomes.


Eligibility Criteria:
Criteria for Classrooms:

Classroom eligibility criteria included: (a) driver education conducted in English, and (b) instructor agreement not to provide or discuss donation information beyond the study video.

Criteria for Adolescent Participants:

Inclusion Criteria:

* Enrolled in driving school class
* English speaking
* Adolescent assent
* Parental permission to participate

Exclusion Criteria:

* Prior participation in a driver's education class in which organ donation education was provided
* Parent permission form not signed
TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma

The goal of this clinical trial is to learn if immune microenvironment modification could improve the effect of chemoradiotherapy for patients with local advanced esophageal squamous cell carcinoma. The main questions it aims to answer are:

1. Does immune microenvironment could be modified by medium dose of three drugs (paclitaxel, cisplatin, 5-FU), PD1 checkpoint inhibitor, probiotics, and thymosin α1？
2. Does induction and consolidation of PD1 checkpoint inhibitor improve the effect of chemoradiotherapy for patients with esophageal cancer?

This is a single arm study. Participants will:

1. Take one cycle of induction chemotherapy (paclitaxel, cisplatin, 5-FU) and immunotherapy (Sintilimab), two cycle of concurrent chemoradiotherapy, one cycle of consolidation chemo-immunotherapy, and then 1 year of immunotherapy.
2. Take probiotics (Clostridium Butyricum) for 1 year and thymosin alpha-1 daily during radiotherapy.

Concurrent chemoradiotherapy is the standard treatment for patients with inoperable local advanced esophageal squamous cell carcinoma. However, over half of patients will relapse. How to improve effects? We focus on tumor microenvironment transformation by three drug chemotherapy, PD1 inhibitor, probiotics, and thymosin α1，and intent to improve radiosensitivity and reduce recurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Sign written informed consent before implementing any trial related procedures;
2. Age range from 18 to 80 years old;
3. Stage II-III and stage IV esophageal squamous cell carcinoma with only extraregional lymph node metastasis determined by histopathology;
4. Inability to undergo surgical resection or patient refusal to undergo surgery;
5. ECOG PS 0-1;
6. Expected survival time\>3 months;
7. Sufficient organ function is required for the subject to meet laboratory indicators

Exclusion Criteria:

1. After esophageal or tracheal stent implantation surgery;
2. Due to the obvious invasion of tumors into adjacent organs (arteries or trachea) of the esophageal lesion, there is a higher risk of Patients at risk of bleeding or perforation, or those who have formed fistulas;
3. Diagnosed as malignant diseases other than esophageal cancer within 3 years prior to initial administration (excluding those that have undergone curative treatment)
4. Currently participating in intervention clinical research treatment, or having received other treatments within 4 weeks prior to initial administration Researching drugs or using research instruments for treatment;
5. Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or targeting another stimulus or synergistic inhibition of T cell receptors (such as CTLA-4, OX-40, CD137) Medications;
Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.

Participants after first-stage of knee infection reimplantation will be assign to one of two groups: with stem vs. with sleeve. Investigators will check participants on clinical, laboratory and reinfection signs. The main hypothesis is that better mechanical stability of endoprosthesis with sleeves will support infection treatment.

All participants will be treated because of periprosthetic joint infection of the knee, after primary arthroplasty. All participants will be treated with two-stage protocol. In first stage debridement and spacer implantation will be performed. After 6-week antibiotics, when will be absent clinical or laboratory signs of reinfection, second stage will be performed. All participants upon fulfillment all inclusion and exclusion criteria will sign informed consent. With computer software patients will be randomized to one of two groups: with stem vs. with sleeve. After operation all patients will get target antibiotics for 3 weeks. Pre-operation and after on periodic controls will checked the Knee Society Score, The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC), Visual Analogue Scale. After 2-year observation evaluation of reinfection rate will be performed in both groups.

Eligibility Criteria:
Inclusion Criteria:

* second-stage of knee reimplantation
* primary knee replacement in primary knee osteoarthritis
* fulfillment of International Consensus Meeting 2018 infection criteria

Exclusion Criteria:

* intraoperative bone defects Anderson Orthopedic Research Institute score \>II
* autoimmune disease
* diabetes
* peripheral vascular disease
* congenital or acquired immunodeficiencies
* lack of pathogens after first-stage
* multi-bacterial infection
* multidirectional instability
* lack of patient consent
Head Start Classroom-based Approaches and Resources for Emotion and Social Skill Promotion (Head Start CARES)

The purpose of this study was to deepen the evidence base for interventions that support the social-emotional skills that underlie children's engagement and attention to learning tasks by schools (learning behaviors) and their social interactions with teachers and peers (social behaviors). The study tested three theoretically-distinct approaches to enhancing children's social-emotional development, along with a comprehensive coaching and training model, on a large scale within the Head Start system.


Eligibility Criteria:
Inclusion Criteria:

* Grantees had to have at least 4 centers with a similar racial/ethnic composition
* An equal number of classrooms with full-day or part-day programs
* And a similar mix of four-year-old-only and mixed-age (three-and four-year-old) classrooms.
* Children had to speak English and Spanish.

Exclusion Criteria:

* A grantee was excluded from the sample if it: only ran early Head Start programs
* Only served migrant children
* Was located in a U.S. territory
* Only or mostly provided family child care or home services
* Was more than 100 miles from a "primary airport,"
* Operated fewer than 4 centers with two classrooms each
* Had been in operation for less than 2 years
* Was not in compliance with Head Start Standards
* They were already systematically implementing a social-emotional curriculum or participating in another evaluation study.
Interest of Using the Sevoflurane in the Prevention of Newborns Pain

The objective of this randomized and controlled study is to compare the sedation with sevoflurane inhalation versus non-nutritive sucking and sucrose administration to facilitate peripheral inserted central catheter insertion in a pediatric and neonatal intensive care. Main measurements concern success or failure of insertion, duration of procedure, movements of the baby, tolerance of treatments evaluated by, mean arterial pressure, heart rate, respiratory frequency and oxygen saturation.


Eligibility Criteria:
Inclusion Criteria:

* Infants born between the 28th and 41th weeks of gestation admitted in intensive care unit
* Patient requiring a mechanical ventilation or CPAP
* Patient requiring a KTEC
* Given consent

Exclusion Criteria:

* Contraindication to sévoflurane
* Patient already sedated with morphin and/or hypnotics
* Patient presenting neurologic troubles
* Patient enrolled in other study\*
* Infant without legacy representant
A Fast-track Versus Conventional Recovery Protocol in Laparoscopic Hysterctomy

Factors affecting to length of hospital stay after fast-track recovery program in laparoscopic hysterectomy compared to conventional recovery program

Factors affecting to length of hospital stay after laparoscopic hysterectomy in fast-track recovery program group compared to conventional recovery group.

The pimary outcome is time to discharge from the end of operation to discharge.

The second outcomes are amount of opioid used and NSAID, postoperative paine, nousea and vomiting, patients satisfaction, anxiety and stress-coping test, operative bleeding, operative time, postoperative complications, the cost of the laparoscopic hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* uterine size less than uterine size at 14 weeks of pregnancy
* at list one friend or family available to care to care after discharge.

Exclusion criteria:

* endometriosis
* contraindications to any of medications used in the study (oxycodone, ketoprofen, or paracetamol)
* language difficulties (inability to understand and speak Finnish or Swedish)
* age older that 70 years
* mental health disability that limit autonomy