cyrilzakka/clinical-trials huggingface dataset:
Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1

The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen.

Alternate-day dosing with the 8mg buprenorphine-naloxone tablet is as safe and effective as daily dosing. Outcomes are improved when the total weekly dose provided during alternate-day dosing is equal to that given during daily dosing.

Eligibility Criteria:
Inclusion Criteria:

Individuals must be currently opioid dependent and meet FDA criteria for narcotic maintenance treatment. Co-morbid substance abuse or dependence disorders may also be present. Individuals must be healthy despite drug dependency.

Exclusion Criteria:

Individuals with evidence of an active Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Axis I psychiatric disorder (e.g. psychosis, manic-depressive illness, organic psychiatric disorders), significant medical illness (e.g. liver or cardiovascular disease) or pregnant female subjects are excluded from study participation.
Clinical Trial on Patient-Specific-Instrumentation Assisted Lapidus Fusion for Hallux Valgus

RCT to compare the effectiveness of PSI assisted Lapidus surgery vs conventional Lapidus surgery in hallux valgus.

Hallux valgus (HV) affects up to 30% of the population. Lapidus surgery, a combination of 1st tarsal-metatarsal joint arthrodesis is one of the most common surgical options for HV. Despite its popularity, the current method alone is not without complications. This will be the world's first Lapidus arthrodesis surgery utilising patient-specific instruments (PSI) as an assistive tool. We hypothesise that PSI will enhance surgical precision, accelerate fusion rates, decrease non-unions, and reduce the need to use bone grafts.

Methods and analysis:

This is a single-blinded, parallel-group, randomised controlled trial comparing the outcome of the 3D-Printed PSI Assisted Lapidus Fusion (n=27) vs Conventional Lapidus Fusion (n=27) for HV deformity. Both groups will receive indentical post-operative rehabilitation of protected weight bearing and splinting. Outcomes measured will include foot function scores, radiological alignment and arthrodesis site assessment with X-ray and High-Resolution Peripheral Quantitative-Computed Tomography, and foot pressure analysis.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic Hallux Valgus
* hallux valgus angle \>20
* 1,2 Inter-metatarsal angle \>9

Exclusion Criteria:

Individuals with (1) disabilities (both physical and mental) which may impair the adherence of the rehabilitation, (2) revision HV surgery, (3) concomitantly undergone additional procedures on the same foot (e.g. claw toe surgery), (4) the use of medications that may influence bone turnover (e.g. chemotherapy, osteoporotic medications) in recent 3 months, (5) medical comorbidity leading to contraindication for surgery, (6) the inability to understand written Chinese/English, (7) who are mentally/physically unable to consent will be excluded.
LMBA02 Protocol for Patients With a Burkitt Lymphoma

To explore in a multicenter international prospective randomized study (phase III) whether rituximab combined with the standard French LMB chemotherapy scheme results in a higher rate of EFS than the LMB chemotherapy scheme alone in patients older than 18 years with Burkitt lymphoma or ALL 3.


Eligibility Criteria:
Inclusion Criteria:

* Age : 18 years or older
* Histologically or cytologically proven Burkitt lymphoma according to the WHO classification
* WHO performance \< 3
* Informed consent

Exclusion Criteria:

* Known HIV positive infection
* Positive serology for HCV and HBV (except after vaccination)
* Patients previously treated for lymphoma
* cardiac disease that contradict anthracycline chemotherapy
* Psychological or psychiatric condition who contradict steroids therapy
* Patients with serious renal failure unrelated to the lymphoma (serum creatinin level higher than 150 mmole/L)
* Cirrhosis or severe hepatic failure unrelated to the lymphoma
* Previous malignant disease except basal cell skin carcinoma or in situ uterine cervix carcinoma
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Primary organ transplant or other immunosuppressive conditions Pregnancy
Morphological Asymmetry in Elite Female Tennis Players

Humans generally develop a preferred upper and lower extremity. Due to repetitive uneven loading, this gradually results in morphological adaptations to the dominant side of the body. The corresponding morphological asymmetry can be further accentuated by (intensively) practicing a unilateral sport such as tennis, which is very popular. Yet, research on this particular topic is scarce, especially in (elite) female players. Furthermore, existing studies only examine the degree of morphological asymmetry of the upper extremity. Therefore, the aim of this study is to explore the morphological differences between the dominant and the non-dominant extremity/side on a whole body level (trunk, upper and lower extremity) in elite female tennis players.


Eligibility Criteria:
Inclusion Criteria:

* Participants will have to be professional, or elite, female tennis players.
* The players will have to participate in international tournaments in Belgium.

Exclusion Criteria:

* N/A
Comparison of Acute Effects of Traditional and Drop Set Training on Fatigue and Proprioception in Bodybuilding Athletes

To compare the acute effects of traditional and drop set training methods on fatigue levels and proprioceptive sensory mechanisms in bodybuilding athletes.

A total of 28 male bodybuilding athletes with an average age of 25.53 years from Giresun and Ordu provinces participated in the study voluntarily. The participants were randomly divided into two groups as traditional training group (GS) (n=14) and drop set training group (DS) (n=14). Borg CR10 Scale and myotonometric measurements (Myoton Pro muscle palpation device) were used to assess fatigue. Myotonometric measurements were performed on the pectoralis major, triceps brachii and deltoideus muscles. Proprioception characteristics were evaluated in four parameters: shoulder flexion, shoulder abduction, elbow flexion and wrist flexion using laser cursor-assisted angle repetition test.

After the application, fatigue levels in pectoralis major, triceps brachii, Borg CR10 parameters and proprioception errors in shoulder flexion, elbow flexion, wrist flexion parameters were significantly higher in the traditional set group compared to the drop set group.

Eligibility Criteria:
Inclusion Criteria:

* -Being male.
* Being between the ages of 20-30.
* To have been doing bodybuilding for at least the last five years.

Exclusion Criteria:

* -Having undergone a serious surgical operation within the last year,
* Having used a performance enhancing product that affects the neuromuscular mechanism within the last year,
* In addition, individuals who did not meet the inclusion criteria were excluded from the study.
Influence of Pre-operative Back Muscle Exercise on Post-operative Outcomes After Spine Surgery

The purpose of this research study is to gather more information about how improving back muscle function before surgery might influence what happens to the spine and function after surgery. This may assist in developing ways to improve surgical outcomes and determine the benefit of pre-operative exercise, if any.

The investigators intend to enroll patients from UCSD spine clinic. The investigators will include patients who are indicated for a spine surgery. Once participants are identified to be surgical candidates, and have an estimated surgical date that is 4-6 weeks from identification, the participants may undergo pre-operative procedures including a pre-operative evaluation and treatment by a physical therapist, data collection (demographics, medical history, etc.), and filling out relevant questionnaires. Patients will undergo their surgery as scheduled with the spine surgeon as part of their planned standard care unless the surgeon decides that the surgery is no longer necessary. Participation in research does not influence the surgeon's decision. Post-operatively, participants may be asked to undergo a post-operative evaluation and fill out questionnaires.

Upon identification of eligibility, participants may be randomized to one of two study arms using a random number generator. If group characteristics are observed to be unbalanced using this approach, participants may be matched according to demographic or surgical features:

1. Pre-habilitation treatment arm
2. Standard of Care arm Participants in the standard of care arm will undergo all pre-operative activities recommended by their surgeon as per standard care.

Eligibility Criteria:
Inclusion Criteria:

* - Individuals undergoing spinal surgery
* Individuals who have been deemed medically safe to participate in an exercise-based physical therapy program

Exclusion Criteria:

* - Individuals with comorbid conditions or spinal injury inappropriate for participating in an exercise-based physical therapy program as determined by the surgeon (e.g. unstable vertebral fracture)
* Individuals that do not have the ability to commit to the therapy schedule either in-clinic or using the web-based interface
* Non-english speaking individuals (some questionnaires are validated only in English)
Hybrid Ablation of Persistent and Long-standing Persistent Stand-alone Atrial Fibrillation

This study evaluates in detail efficacy and safety (including neurological safety) of hybrid ablation of stand-alone, persistent and long-standing persistent atrial fibrillation (AF). An implantable ECG monitor will be implanted to all patients for rhythm monitoring. Neurological safety will be assessed by cerebral magnetic resonance, neuropsychological examination and periprocedural transcranial Doppler measurement.

Hybrid ablation (i.e. surgical thoracoscopic ablation, followed by catheter endocardial ablation) represent a new treatment option for patients with atrial fibrillation.

60 patients will undergo a two-stage, hybrid ablation, all of them will have an ECG monitoring device implanted and will be followed for up to three years. Neurological safety of both surgical and catheter procedures will be assessed by three examinations. Magnetic resonance will be performed before surgery, 5 days after surgery and at the 180 days visit to search for (subclinical) cerebral ischemia. Complex neuropsychological examination will be performed before surgery, afer 1 month after surgery and at 180 days visit to search for changes in cognitive functions, behavioral functions etc. Transcranial Doppler will be performed during surgical and catheter ablation to detect microembolic signals.

Eligibility Criteria:
Inclusion Criteria:

* Patients age \> 18 years
* Patients with persistent/long-standing persistent AF according to the standard EHRA definition.
* Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication.
* Absence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)
* Ability to sign an informed consent

Exclusion Criteria:

* Paroxysmal AF
* AF secondary to a reversible cause (i.e., thyreopathy, etc.)
* Indication for open-heart surgery (coronary artery bypass grafting, valve surgery, etc.)
* Severe left ventricle dysfunction that is clearly caused by some other cardiac disease (dilated cardiomyopathy, ischaemic heart disease, etc.) where the AF is clearly of secondary etiology
* Known severe pericardial and pleural adhesions (e.g., history of cardiac surgery)
Salpingectomy at the Time of Elective Laparoscopic Cholecystectomy (SaLCHE)

Prophylactic salpingectomy (also called opportunistic, risk-reducing or incidental salpingectomy) has been advocated at the time of gynecologic surgery to reduce the risk of serous ovarian cancer. This study explores the acceptability and feasibility of opportunistic salpingectomy at the time of elective laparoscopic cholecystectomy (LCHE).

Many serous ovarian cancers are now thought to originate in the fimbria of the fallopian tubes. This has led a number of professional societies worldwide to recommend consideration of prophylactic salpingectomy at the time of elective gynecologic surgery or tubal sterilization.

This study explores the acceptability and feasibility of incidental (opportunistic, risk-reducing, prophylactic) salpingectomy at the time of a common nongynecologic procedure in women, i.e. elective laparoscopic cholecystectomy (LCHE). The study addresses whether women ≥45 years would accept opportunistic salpingectomy and the technical feasibility (time, port placement, complications) in women who consented to salpingectomy.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled (elective) laparoscopic cholecystectomy for a benign indication
* Age \>45 years
* Consent

Exclusion Criteria:

* Age \<45 years
* Desire to preserve fertility
* Cholecystectomy for malignant disease
* Extensive previous abdominal surgery
Postoperative Analgesia Following Wisdom Teeth Removal: Ropivacaine Versus Placebo

The main objective of this study is to demonstrate the superiority of local analgesia with ropivacaine versus placebo on postoperative pain during the first 24 hours following bilateral surgery of all four third molars under general anesthesia.

The secondary objectives of this study are to compare regional anesthesia by ropivacaine versus placebo for the bilateral resection of all four third molars under general anesthesia, in terms of:

A. intraoperative use of propofol and remifentanil B. postoperative pain (EVN) at different time points C. in-hospital analgesic consumption D. time to first rescue analgesic request E. time spent in the post interventional treatment room F. length of hospital stay G. side effects H. analgesic consumption at home I. analgesic consumption (total) J. patient satisfaction K. Chronic pain after surgery

Eligibility Criteria:
Inclusion Criteria:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient is available for 3 months of follow-up
* American Society of Anesthesiology (ASA) score of 1, 2 or 3
* Patient programmed for surgical removal of all 4 wisdom teeth, excluding all other teeth, under general anesthesia

Exclusion Criteria:

* The patient is participating in another study
* The patient is in an exclusion period determined by a previous study
* The patient is over 18 years old and under judicial protection, under tutorship or curatorship
* The patient (or legal representative)refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* Ineffective contraceptive
* Addiction or chronic pain treated with morphine
* Contra-indication for regional anesthesia (eg congenital or acquired coagulopathy, infection, allergy)
* Contra-indication to local anesthetics, general anesthetics and analgesics used in the protocol.
* Difficult cooperation, psychiatric disorders that could interfere with assessments
* Hypersensitivity to ropivacaine or other local anesthetics with amide links
* Contra-indication for the use of NaCl 0.9%: all states of sodium and water retention (especially heart failure, edema and ascites syndrome associated with cirrhosis)
Study to Detect Changes in Urinary and Gut Microbiome During Androgen Deprivation Therapy and Radiation Therapy in Patients With Prostate Cancer

This study collects urine and stool samples to determine the ability to identify changes in the microbiome (bacteria, fungi, and viruses that live in the gut and urine) of patients with prostate cancer during androgen deprivation therapy and radiation therapy. Radiation therapy has the potential to harm the genitourinary area or the bowel, causing a feeling of urgency or increased inflammation in the area. The radiation therapy is designed to not irradiate the bowel and bladder areas, but there is still some radiation exposure. The gut microbiome has been associated with differences in inflammation as well as producing molecules that influence healing. The purpose of this study is to see whether the microbiome may contribute to the healing of the organs exposed to radiation. Information learned from this study may help researchers discover a new risk factor that could be manipulated to improve the quality of life in patients with prostate cancer.

PRIMARY OBJECTIVE:

I. To determine the feasibility of identifying changes in urine and gut microbiomes during androgen deprivation therapy and radiation therapy for prostate cancer.

SECONDARY OBJECTIVE:

I. To explore associations between baseline microbiomes and urinary or gastrointestinal radiation toxicity by Common Terminology Criteria for Adverse Events (CTCAE) and Patient Reported Outcomes (PRO).

OUTLINE:

Patients undergo collection of stool and urine samples within 2 weeks before hormone therapy or radiation therapy, after hormone therapy but before start of radiation therapy, and after completion of radiation therapy. Patients also complete a series of questionnaires prior to starting radiation therapy, mid-way through radiation therapy, and after completion of radiation therapy (within 1-3 weeks, at 3 months, and then every 6 months until 3 years from radiation completion). Patients' medical records are also reviewed.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed prostate cancer, with a plan to receive radiation therapy for either definitive (cohort A) or salvage (cohort B) therapy. Patients without planned androgen deprivation therapy (ADT) will be accrued to cohort C

  * Cohort A will be restricted to Gleason grade group 3 or higher (4+3 or 8-10) so that androgen deprivation will be indicated
  * Cohort B will not be restricted by Gleason grade but will require rising prostate-specific antigen (PSA) and a plan for ADT with salvage radiation
  * Cohort C will be prostate cancer patients in whom definitive or salvage radiation is planned without ADT
* Patients must be age 18 or older
* Willing to provide urine and stool samples at specified time points

Exclusion Criteria:

* Men with inflammatory bowel disease or pre-existing cystitis will be excluded
Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV

This prospective study was conducted at Ain Shams University Hospital, Internal Medicine, Hepatology and Gastroenterology Department, and Tropical Medicine Department.

To compare the efficacy of the combination of sofosbuvir and simeprevir for 12 weeks with the combination of sofosbuvir and ribavirin for 24 weeks in Egyptian patients with HCV-related Child A cirrhosis.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic HCV infection with a positive HCV RNA level by PCR.

Exclusion Criteria:

* Total bilirubin \> 2 mg/dl.
* serum albumin \< 2.8 g/dl.
* INR \> 1.7.
* platelet count \< 50000/mm3.
* serum creatinine \> 2.5 mg/dl.
* patients presented by ascites or hepatic encephalopathy.
* patients with evidence of other causes of liver diseases, including hepatitis A, hepatitis B, autoimmune hepatitis, alcoholic liver disease, drug-induced hepatitis, haemochromatosis, Wilson disease or alpha-1 antitrypsin deficiency.
* patients with any advanced systemic disease.
* pregnancy or inability to use effective contraception in females.
Autologous Stem Cell Transplantation and Maintenance Therapy for Multiple Myeloma

This trial will determine the feasibility and efficacy of lenalidomide as maintenance therapy in Multiple Myeloma patients treated with dose intensive chemotherapy (Melphalan 200 mg/m2) with autologous PBSC transplant.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 to 75 years of age.
* ECOG performance status of 0, 1 or 2.
* Patients who have a history of another malignant disorder are eligible, provided that they have not received active therapy for 5 years. Patients with basal cell and squamous cell skin cancers are eligible.
* Patients who are pregnant are ineligible.
* Patients must furnish written informed consent and HIPAA authorization for release of personal health information.
* Patients must be able to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments.
* Patients must be HIV and HTLV-I,-II antibody sero-negative.
* Patients must have adequate visceral organ function

Exclusion Criteria:

* Patients are ineligible if they have received cumulative chemotherapy doses in excess of: carmustine (BCNU) 400 mg/m2, or a cumulative anthracycline exposure in excess of 550 mg/m2 Adriamycin (doxorubicin) unless the gated-pool radionuclide cardiac scan shows greater than/equal to 45% ejection fraction.
* Patients are ineligible if they are receiving any other investigational agents.
Phase 3 Study to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022

The purpose of this study is to Evaluate the Efficacy and Safety of Co-administrated AD-2021 and AD-2022

Condition or disease : Primary Hypercholesterolemia and Essential Hypertension Intervention/treatment Drug : AD-2021 Drug : AD-2022 Drug : AD-2021 Placebo Drug : AD-2022 Placebo Phase : Phase 3

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Subjects with hypertension and hyperlipidemia

Exclusion Criteria:

* Patient with known or suspected secondary hypertension
* Other exclusions applied
Safety Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in Indian Participants With Breast Cancer

This is a Phase 4, single-arm, open-label, multicenter study to assess the safety and efficacy of pertuzumab in combination with trastuzumab and docetaxel for the treatment of participants with human epidermal growth factor receptor 2 (HER2)-positive advanced (locally recurrent, unresectable, or metastatic) breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the participant and/or partner
* Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection; participants with measurable and/or non-measurable disease are eligible
* Known and documented HER2-positive
* Known and documented LVEF of at least 50 percent (%)
* Adequate organ function
* A negative serum beta-human chorionic gonadotropin (beta-HCG) test for women of childbearing potential (premenopausal, or less than \[\<\] 12 months of amenorrhea post-menopause, and women who have not undergone surgical sterilization \[absence of ovaries and/or uterus\]) within 7 days prior to the first dose of study treatment with the result available prior to first dosing

Exclusion Criteria:

* Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally recurrent disease
* Pregnant or lactating women
* Current clinical or radiographic evidence of central nervous system (CNS) metastases
* Disease progression while receiving or within 12 months of completion of trastuzumab and/or lapatinib treatment in the adjuvant or neo-adjuvant setting
* History of LVEF decline to below 50% during or after prior trastuzumab adjuvant or neo-adjuvant therapy