cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Sutures in Periodontal Surgery

The aims of this study were to evaluate and compare tissue erythema, edema and knot loosening among four types of suture one week after periodontal surgery.

Forty patients participated in this prospective, randomized, double-blind clinical trial. Vertical mattress sutures were used following resective periodontal surgery performed by one operator. Four suture materials were selected for evaluation: 5-0 silk; 5-0 polypropylene; 5-0 polyglycolic acid (PGA), and 4-0 polytetrafluoroethylene (PTFE). Seven days after the surgical procedure, the surgeon assessed suture loosening and removed the sutures. A blind researcher clinically evaluated erythema and edema.

Eligibility Criteria:
Inclusion Criteria:

* Qualification for the study was based on the need for resective periodontal surgery (apically positioned flap and osseous recontouring) at four or more consecutive interproximal sites per quadrant

Exclusion Criteria:

* systemic diseases, such as diabetes, chronic obstructive pulmonary disease, or an immunologic disease that would affect wound healing; allergies to prescribed medication; and/or current pregnancy or breast feeding were excluded from the study
Pain and Quality of Life After Retromuscular Ventral Hernia Repair (RECOVER)

The study aims to explore the difference in outcomes relating to pain and quality of life after open, laparoscopic, and robotic-assisted retromuscular ventral hernia repair.

This is a prospective, multicenter, observational study assessing outcomes relating to pain and quality of life for subjects undergoing open, laparoscopic, or robotic-assisted retromuscular ventral hernia repair. The study will focus on short-term post-operative outcomes through 3 months. The study will also collect recurrence data through 1 year. During the post-operative period through 3 months, pain medication intake, subject reported pain (on post-operative day 7, 14, 21, 28, and 3 months) and quality of life (on day 28, 3 months, and 1 year) and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Subject is between 18 and 89 years of age
* Subject is a candidate for an elective retromuscular ventral hernia repair under general anesthesia
* Subject has access to complete study assessments electronically and agrees to comply with all follow-up requirements
* Ventral hernia is \>= 4cm

Exclusion Criteria:

* Subject who will have an emergent hernia repair
* Subject has a parastomal hernia (i.e. hernia related to ostomy formation)
* Subject with a history of chronic pain and/or taking daily pain medication for \>6 weeks
* Subject wtih a history of substance abuse (excluding marijuana) and/or current (within 30 days) narcotic use
* Subject with a history of MRSA infection
* Subject with HbA1c level \> 8.5%
* Subject undergoing a minimally invasive (MIS) repair who will require the use of Exparel during the surgical procedure
* Subject who will undergo a concomitant hernia repair or any other concomitant procedure
* Subject has cirrhosis
* Current nicotine use (including vaping) within the past 30 days
* Subject is contraindicated for general anesthesia or surgery
* Subject has a known bleeding or clotting disorder
* Pregnant or suspected pregnancy
* Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with the study requirements or ability to provide informed consent
* Subject belonging to other vulnerable population, e.g., prisoner or ward of state
* Subject is currently participating in another interventional research study
Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease

This study is a placebo-controlled, double-blind trial that will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease. The medication will be administered orally as 8 ounces of hydrogen-enriched drinking water twice a day over the course of one year.

This study will investigate the safety and tolerability of molecular hydrogen, a promising antioxidant agent, in patients with early-stage Parkinson's Disease. Subjects will be sequentially randomized in a 1:1 ratio to receive hydrogen-enriched water or the corresponding placebo twice a day, in addition to all standard-of-care treatments. Enrollment goal is 70 subjects. Duration of therapy is 52 weeks.

The primary outcome measures are safety and tolerability of hydrogen-enriched water. Secondary outcome measures include: progression of motor symptoms, health-related quality of life, progression of cognitive decline, and progression of symptom burden.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease
* Modified Hoehn \& Yahr Stage \< III
* Diagnosis of Parkinson's Disease made within past 3 years•
* Ability to complete questionnaires
* Willingness to go off parkinsonian medication for 12 hours prior to baseline and 56-week assessments

Exclusion Criteria:

* Other major diseases of the central nervous system
* History of stroke
* Use of antipsychotic neuroleptic medication within the last 6 months
* Symptomatic (secondary) parkinsonism
* Atypical parkinsonian variants
* Unstable medical or psychiatric illness
* Known kidney disease
* History of stereotactic brain surgery
* Significant cognitive impairment
* Inability to safely tolerate 8 ounces of water twice daily associated with the study medication
* Unable to avoid regular use of medications containing magnesium
* Treatment with another investigational drug within the last 30 days that may interfere with the study medication
* Pregnancy or nursing
Use of a Mesh to Prevent Parastomal Hernia

Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum,
* Aged over 18,
* Charlson comorbidity index below 7
* Elective surgery
* Radical surgery

Exclusion Criteria:

* Loop colostomies,
* Emergency surgery,
* Body mass index above 35 kg/sq.m.,
* Palliative surgery,
* Hepatic cirrhosis,
* Severe COPD (requiring home oxygen treatment),
* Corticoid treatment
Enhancing Early Care and Education Through Reflective Supervision

The goal of this clinical trial is to test an enhancement to early care and education, which is a professional development series that includes a foundational training and skill development workshops focused on training and supporting early learning supervisors in Reflective Practice and Supervision. Directors and education coordinators within state pre-kindergarten programs, and the teachers they supervise, will be the focus of this research. Hypothesized outcomes include promotion of reflective capacity and supervisory skill in supervisors, more effective supervisor-supervisee interactions, increases in reflective functioning and well-being in supervisees, increases in positive teaching practices and observed classroom quality, and increases in adaptive social-emotional development among children alongside prevention of emotion regulation difficulties. Researchers will compare whether these outcomes differ between participants who are currently receiving the Reflective Supervision enhancement and participants who are in the waitlist control condition.


Eligibility Criteria:
Inclusion Criteria:

* Supervisor in Rhode Island state pre-kindergarten program

Exclusion Criteria:

* Does not meet inclusion criteria above
Caffeinated Chewing Gum on Special Forces Performance

The purpose of this project is to investigate the effects of caffeine chewing gum on the cognitive functions and special operations capabilities of special forces.

Using a randomisation crossover design, 20-40 active-duty special forces members who had undergone leave and special forces reserve training were divided into a caffeine trial (CAF) and a placebo trail (PL). After chewing caffeine-containing gum containing 5 mg/kg (CAF group) or caffeine-free gum (PL group) for 15 minutes, then performed a simple reaction test, a stroop test, a visual search test, a grip strength test, a vertical jump test, a 20-metre sprint test, and a counter-terrorism simulation test. A heart rate monitor was used to measure the heart rate and heart rate variability of the participants. Saliva samples were collected and analysed for α-Amylase, cortisol and caffeine concentrations before the test, after a 15-minute break from chewing gum and at the end of the test. Completion time of cognitive functions, grip strength, vertical jump height, 20 m sprint time, time to completion of the counterterrorism simulation test, and target score will be analysed using paired-sample t-tests.

Eligibility Criteria:
Inclusion Criteria:

* Active Special Warfare Unit members who have passed the Grade A Special Forces Reserve Training
* No cardiovascular and joint diseases
* Adult male over 20 years old

Exclusion Criteria:

* Non-active Special Warfare Unit members
* Have cardiovascular and joint diseases
* Under age
SLAP Repair vs. Biceps Tenodesis in Patients Under 30: A Randomized Clinical Trial

One of the common complaints after SLAP repair is pain and stiffness. However, the more recently-described Biceps Tenodesis for SLAP tears improves upon this by addressing the long head of biceps which is thought to be the pain sources. However, only one small prior RCT has evaluated this, finding minimal difference. Both procedures are currently considered standard of care, and are decided upon based on patient and surgeon preference.

This will be a single-center randomized controlled trial. The study is comparing SLAP repair and biceps tenodesis in patients under 30 undergoing surgery for SLAP tears. The purpose of the proposed study is to evaluate the effect of SLAP repair versus biceps tenodesis in the management of SLAP tears in patients under 30 years old.

Superior-labrum anterior to posterior (SLAP) tears were first described by Andrews et al. in 1985, and have been reported to be present in up to 26% of shoulder arthroscopies. While the exact cause of SLAP tears is unknown, they are often related to traumatic events and sports activity, particularly overhead sports such as baseball. Type II SLAP tears, which are characterized by superior labral fraying with a detached biceps anchor, are the most common subtype, based on the classification by Snyder et al. Treatment options include SLAP repair, biceps tenodesis, biceps tenotomy, and debridement.

One of the common complaints after SLAP repair is pain and stiffness. However, the more recently-described Biceps Tenodesis for SLAP tears improves upon this by addressing the long head of biceps which is thought to be the pain sources. However, only one small prior RCT has evaluated this, finding minimal difference. Both procedures are currently considered standard of care, and are decided upon based on patient and surgeon preference.

This will be a single-center randomized controlled trial. The study is comparing SLAP repair and biceps tenodesis in patients under 30 undergoing surgery for SLAP tears. The purpose of the proposed study is to evaluate the effect of SLAP repair versus biceps tenodesis in the management of SLAP tears in patients under 30 years old.

Eligibility Criteria:
Inclusion Criteria:

* Primary indication is for SLAP tear
* Age 18-30
* Willing and able to provide consent

Exclusion Criteria:

* Associated rotator cuff tear requiring arthroscopic repair
* Pregnant patient
* Previous shoulder surgery
* Age \> 30, or \< 18
Non-invasive Venous Air Plethysmography Assessment of Venous Hemodynamics in Patients Suspected Deep Venous Obstruction Used in Conjunction with Intermittent Pneumatic Compression.

The purpose of this research is to measure changes in venous blood flow with an air-filled bladder under an intermittent pneumatic compression device cuff (used to prevent deep venous thrombosis) or venous diagnostic device cuff (used to detect deep venous thrombosis). The devices being used in the study are investigational and not FDA-cleared.


Eligibility Criteria:
Inclusion Criteria:

* Venous ultrasound study to evaluate for lower extremity DVT unilateral and/or bilateral within previous 72 hours.

Exclusion Criteria:

* Patients with inaccessible target limb (ultrasound limb) due to bandages (wound, burn, lesion, etc) or cast.
* Patients with leg trauma, fracture, above or below knee amputation, or other condition in which compressing on the calf is medically inappropriate or not possible.
* Patients unable to provide informed written consent.
Somatostatin Receptors Imaging in Relapsing and Refractory Multiple Myeloma Patients

This study wil assess somatostatin receptor (SSTR) expression via the uptake of Gallium-68 labelled DOTA-conjugated SSTR targeting peptide using PET/CT imaging in multiple myeloma lesions pre-identified on 18F-FDG PET/CT in order to evaluate the feasibility of molecular radionuclide therapy in refractory and relapsing mutiple myeloma using the Lutetium-177 radiolabelled targeting peptide.


Eligibility Criteria:
Inclusion Criteria:

* Age above or equal to 18 years
* Written informed consent in accordance with institutional guidelines and obtained prior to any study procedures
* Confirmed diagnosis of multiple myeloma according to the Salmon and Durie criteria
* Has received at least 3 lines of treatment, exposed and refractory (or non-eligible) to the 5 major drugs (lenalidomid, pomalidomid, bortezomib, carfilzomib, daratumumab)
* Life expectancy above 3 months
* Active (relapsing or refractory) and measurable disease (on 18F-FDG PET/CT (performed within 4 weeks prior SSTR PET/CT) and biologically)
* Adequate renal function with GFR above or equal to 30mL/min/1.73m²
* Bone marrow aspiration and biopsy sample available within 30 days prior study enrolment with positive SSTR2 IHC

Exclusion Criteria:

* Pregnant or lactating patients
* Other active neoplastic disease
* Treatment by another molecule that is object of investigation within 30 days prior SSTR PET/CT
* Eastern Cooperative Oncology Group Performance Status above or equal to 3
* Corticoids administration at a therapeutic level (total dose of 160 mg of dexamethasone or equivalent) two weeks prior enrolment
Primary Care Intervention for PTSD in Ethiopia

Mixed methods (qualitative and quantitative) cluster randomized pilot feasibility trial (n=40) to refine the the Brief Relaxation, Education and Trauma Healing (BREATHE) Ethiopia intervention and explore effectiveness and implementation. Fifty patients will be enrolled across the pre-pilot and the pilot to account for potential treatment dropout. Eight health care centers will be randomized to Treatment or Waitlist conditions.

1. Primary outcomes: Change in hypothesized treatment mechanisms: (1) increased knowledge about PTSD; reductions in (2) PTSD-related stigma; (3) trauma-related cognitions; and (4) self-reported arousal; (5) increased use of stress management strategies; and (6) reductions in physiological arousal as measured by increased heart rate variability.
2. Secondary outcomes: Change in symptoms and functional impairment. Reductions in (1) PTSD (2) depression and anxiety symptoms, and (3) functional impairment.
3. Process evaluation: Mixed methods multi-stakeholder process evaluation of the implementation of the intervention as measured by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance). We will collect qualitative data on Adoption and Implementation (e.g. facilitators and barriers to intervention delivery) and quantitative assessment of patient and provider participation and retention (Reach), satisfaction (Adoption) and fidelity (Implementation).


Eligibility Criteria:
Inclusion Criteria:

1. For all participants: Being 18 years of age or older
2. For all participants: Being able and willing to provide informed consent to participate in the study
3. For all participants: Being able to complete procedures in Amharic or English.
4. For patients: Treatment at a Sodo district primary care clinic for Severe Mental Illness (SMI)
5. For patients: Identified as having:

   1. Experienced a traumatic event,
   2. Associated PTSD symptoms defined as scores on the PTSD Checklist DSM-5 (PCL-5), AND
   3. any associated functional impairment on the WHODAS-2.
6. For health care providers: Providers working at the target health centers who administer, provider care for, or supervise the care of patients with mental health concerns.
7. For caregivers: Being identified by the patient as a close family member or friend whom the patient gives permission to be involved in the study

Exclusion Criteria:

1. Current high risk of suicide as measured by the Composite International Diagnostic Interview (CIDI) Suicide module
2. Inability to participate in the treatment, as determined by the psychiatric nurse.
MAX-10181 in Patients With Advanced Solid Tumor

This is a multi-center, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumor.

This is a multi-center, first-in-human, non-randomized, open-label, single-arm, dose-escalation Phase I study to evaluate the safety and tolerability of MAX-10181 in patients with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

* Males and/or females over age 18.
* Histologically or cytologically confirmed advanced or metastatic solid tumor for -which no established standard therapy is available.
* At least one measurable lesion by CT or MRI according to RECIST1.1, which is not in irradiated area (only for expansion phase).
* Recovered from toxicities of prior anti-cancer treatment to Grade 1 or less (in case of alopecia, Grade 2 is acceptable).
* Life expectancy of at least 3 months.
* Female participants of child bearing potential agree not to be pregnant or lactating during the study and for three months following the last dose of study drug. Both men and women of reproductive potential must agree to use a highly effective method of birth control during the study and for three months following the last dose of study drug. A highly effective method of contraception is defined as one that results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly.

Exclusion Criteria:

* Laboratory values not within the Protocol-defined range.
* Cardiac disease with New York Heart Association (NYHA) Class III or IV, including congestive heart failure, myocardial infarction within 6 months prior to the trial entry, unstable arrhythmia, or symptomatic peripheral arterial vascular disease.
* Previously treated malignancies other than the current disease, except for adequately treated non-melanoma skin cancer, in situ cancer, or other cancer from which the subject has been disease-free for at least 5 years at the trial entry.
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.

Major surgery, other than diagnostic surgery, within 4 weeks prior to the trial entry, without complete recovery.

* Medical history of difficulty swallowing, malabsorption or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested product.
* Anti-cancer treatment with radiation therapy, surgery, chemotherapy, targeted therapies (erlotinib, lapatinib, etc.), hormone therapy, or immunotherapy within 4 weeks (6 weeks for nitrosoureas or Mitomycin C) prior to trial entry.
* Known infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
* History of upper gastrointestinal hemorrhage, peptic ulcer disease, or bleeding diathesis.
* History of organ allograft, autologous stem cell transplantation, or allogeneic stem cell transplantation.
* Concomitant disease or condition that could interfere with the conduct of the trial, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this trial.
Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections

The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.

A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 to 90 years of age, inclusive,
* Female patients can participate if they are surgically sterilized or postmenopausal for at least 1 year or her sexual partner has had a vasectomy
* Female of childbearing potential has had normal menstrual periods for 3 months and negative serum pregnancy test and agree to practice highly effective methods of birth control during treatment and for at least 7 days after last dose
* Intraoperative/postoperative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
* Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory indicators; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections

Exclusion Criteria:

* Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious
* Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
* Patients whose surgery will include staged abdominal repair, or "open abdomen" technique, or marsupialization
* Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis
* Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality