cyrilzakka/clinical-trials huggingface dataset:
Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas)

Synopsis Title of Study A prospective, randomized, single blind multicentre phase III study on organ preservation with Custodiol-N compared with Custodiol solution in organ transplantation (kidney, liver and pancreas)

Protocol number: CL-N-KLP-TX-III/07-AT/17

Trial design The study design is a prospective, randomized, single blind, multicentre, phase III comparison study of organ perfusion intended to demonstrate non-inferiority of Custodiol-N against Custodiol in organ transplantation of kidney, combined kidney-pancreas and liver.

Intended duration of study The overall duration for the trial is expected to be approximately 30 months. The du-ration of the trial for each subject is expected to be 3 months (transplantation and a follow-up period of 90 days).

Purpose of the study

The objective of this investigation is to demonstrate non-inferiority of graft preservation with Custodiol-N compared to Custodiol with respect to both graft function and injury after transplantation of kidney, liver or combined kidney-pancreas.

Patient selection The study population will be selected from patients who will undergo kidney, liver or combined kidney-pancreas transplantation. Patients of each gender will be included in the study.

Planned number of patients (recipients)

In total N=362 including:

Kidney 242 (including approx. 30 combined kidney-pancreas)

Liver 120


Eligibility Criteria:
Inclusion Criteria:

* All organs (kidney, combined kidney - pancreas and liver) Donor criteria

For All patients undergoing deceased donation:

- deceased adult (≥18 years) donors fulfilling the criteria for organ donation

For All patients undergoing living kidney donation:

- adult (≥18 years) living kidney donors fulfilling the criteria for organ donation

Patient (recipient) criteria

* recipients awaiting their transplant
* recipients ≥18 years
* recipients' signed informed consent before the transplantation Kidney / combined kidney - pancreas recipients
* n/a Liver recipient
* full organ transplantation

Exclusion Criteria:

* All organs (kidney, combined kidney - pancreas and liver) Donor criteria (not applicable for living kidney donors)
* - donors whose organs are all allocated out of retrieving study center
* general refusal of organ donation
* donation after cardiac death (DCD) Patient (recipient) criteria
* pregnant or lactating patients
* recipients participating in any interventional study (e.g. another study involving compound/interventions aimed at the reduction of preservation and / or ischemia / reperfusion injury)
* all combined allocations other than pancreas and kidney

Kidney / combined kidney -pancreas recipient

* double kidney transplantation
* pancreas retransplantation
* machine perfusion According to the KDIGO-Guidelines (2009) all patients with PRA \>0% are only included in the living donation setting.

Liver recipient

* retransplantation
* machine perfusion
A Study Of Two Oral Preparations Of 2 Mg Alprazolam In Healthy Volunteers Under Fasting Conditions

The purpose of this study is to compare bioavailability between formulations of alprazolam in tablets to determine their bioequivalence in terms of rate and magnitude of absorption.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (male or female)
* Age between 18-40 years
* body mass index (Quetelet´s index) between 18-27

Exclusion Criteria:

* Unhealthy subjects
* Volunteers who require any medication over the course of the study
* Volunteers who have received investigational drugs within 60 days prior to the study
Transcutaneous Posterior Tibial Nerve Stimulation for Premature Ejaculation

Objective: Evaluate the effectiveness and safety of transcutaneous electrostimulation of the posterior tibial nerve alone and combined with standard pharmacological treatment, in men with primary premature ejaculation, compared to standard pharmacological treatment.

Patients and methods: Randomized controlled clinical trial. Patients diagnosed with premature ejaculation attending Boston Medical Group clinics in Colombia and Spain will be included. Participants will be assigned by randomization to one of three treatment groups:

* Group 1: Tens + placebo drug therapy
* Group 2: Standard treatment (paroxetine 20 mg) + placebo therapy
* Group 3: Tens therapy + standard treatment (paroxetine mg)

The change in intravaginal latency time measured with the couple's sustained stopwatch, the change in the PEDT scale, the perception of the change in their initial condition after treatment (Global Clinical impression of change scale), and the change in different domains of the EP (PEP Scale - Profile Ejaculation Premature) at the end of treatment (week 12) and at three months of follow-up (week 24).


Eligibility Criteria:
Inclusion Criteria:

* Primary premature ejaculation as defined by the International Society for Sexual Medicine (ISSM-International Society for Sexual Medicine) (30): a) ejaculation occurs always or almost always within the first minute after penetration, b) disability to delay ejaculation in all or almost all penetrations, c) negative personal consequences are generated, such as stress, discomfort, frustration and / or avoidance of sexual intimacy.
* Age equal to or greater than 18 years.
* PEDT score greater than 11.
* Stable heterosexual relationship of at least 6 months with the interest of maintaining it for at least the duration of the study.
* Sexual activity at least once a week.
* Minimum chronicity of PE of 6 months.
* Voluntary participation in the study.
* Signature of informed consent prior to participation in the study.

Exclusion Criteria:

* IIEF-EF score greater than 25.
* Clinically significant comorbidity: cardiovascular, hepatic, thromboembolic, neurological, locomotive, endocrine, oncological, renal or rheumatologic.
* History of retroperitoneal surgery, radiotherapy or multiple sclerosis.
* History of mental illness: depression, anxiety, suicidal behavior, bipolar disorder, agoraphobia, dysthymia, social phobia, obsessive compulsive disorder, post-traumatic stress, psychiatric disorder, referred by the patient or by the use of a medication for one of these terms.
* Consumption of medications that affect ejaculatory control such as psychiatric medications, opioid analgesics, alpha blockers.
* Treatment for PD in the last 3 months.
* Treatment for epileptic syndromes or Parkinson's disease.
* Use of pacemaker or cardiac defibrillator.
* Skin lesions in the electrode placement area.
* Abuse or dependence on piscoactive substances: alcohol, hallucinogenic drugs.
* Couple in a state of pregnancy.
Effectiveness of an Innovative Program in Primary Care for Vulnerable and Precarious Population With Access Barriers to Healthcare System: PASS de Ville

Since the end of 2018, the Care and Orientation Center (CASO)of Marseille corridnated by Medecins du Monde has been investigated an innovative program aimed at direct referrals to primary care for vulnerable and precarious population with access barriers to healthcare system (no being coveraged at time of the study).

Patients consulting at the CASO MDM in Marseille are accompanied and were received, free of charge, by primary care professionals (general practitioners, specialists, pharmacy, analysis laboratory, etc).

This is an observational, comparative study, with two arms: the CASO MDM in Marseille for the intervention site and the CASO MDM in Bordeaux for the control site (where the innovative program does not exist).

A total of 610 patients will be included (305 in the innovative group / 305 in the control group).

The main objective is to evaluate the effectiveness of the innovative programm (PASS de ville) compared to the standard of care by assessing the rate of emergency departement visits at one year in each group.

Duration of inclusion: 12 months; Duration of follow-up: 18 months; Total duration of the study: 36 months.

Both quantitative and qualitative analyses will be conducted to address overall outcomes.

Univariate and multivariate analyzes will be performed on the primary outcome as well as the secondary outcomes in order to highlight significant differences between the two groups and to identify predictive factors for improved effectiveness. The analysis will be conducted in accordance with Good Epidemiological Practices, and the final report will be written according to the CONSORT (Consolidated Standards of Reporting Trials) recommendations. An intention to treat analysis will be conducted.


Eligibility Criteria:
Inclusion Criteria:

* at least 18 years old
* without health coverage
* having medical needs
* not presenting a vital emergency
* not requiring hospital technical platform
* having declared to want to stay in the area at least 18 months afetr inclusion in the study
* having signed the notice of non opposition to the study

Exclusion Criteria:

* less than 18 years old
* having effective health coverage
* in a life-saving emergency
* needing access to the hospital technical platform
* presenting cognitive impairment that limits comprehension
Training for Health Professionals In Tanzania

The goal of this randomized, controlled, single blinded trial is to evaluate the effectiveness of an Afrocentric sexual health curriculum on health professional students' knowledge, attitudes, and clinical skills in providing sexual health care in Tanzania.

There were 563 students recruited for the study that met the eligibility requirement. A total of 412 students gave consent and were randomized into intervention and control groups. At baseline, participants took a survey covering demographic information, educational background, sexual health knowledge, and attitudes toward sexual health topics. After completing the survey, participants participated in two standardized patient interviews involving actors role playing sexual health-related patient scenarios.

Those who were in the intervention arm participated in a 4-day sexual health curriculum followed by a post-test survey measuring sexual health knowledge, attitudes, and evaluation of sexual health training.

Three to four months later, intervention and waitlist control participants completed a follow-up survey assessing sexual health knowledge and attitudes toward sexual health topics and standardized patients scenarios.

Multiple linear regression was used to assess the overall effectiveness of the sexual health curriculum on the attitudes, knowledge, and skills of health professionals after it has been implemented.

Eligibility Criteria:
Inclusion Criteria:

1. current student at MUHAS in midwifery, nursing, or medicine.
2. 3rd or 4th year for medical students or 2nd or 3rd year for nursing and midwifery students.
3. able to attend the full 4-day training during the first week of student vacation.
4. fluent in English (the language of instruction at MUHAS) and Kiswahili (the lingua franca in Tanzania).
5. willing to volunteer and complete all evaluation procedures.

Exclusion Criteria:

1. students who will not be able to attend MUHAS all days of the seminar or be on the MUHAS campus for the follow-up dates.
2. students who express severe reservations about attending (e.g., due to religious objections).
3. Students who express fear of violence due to attending (e.g., from a spouse or relative).
Electronic Health Record Strategies to Promote Diverse Participation in Research AIM 2

Based on the outcomes of the initial study (NCT05348603), this optimization study will employ the most effective interventions (letters and messages) and distribute these communications to underrepresented minorities to further promote interest in research. Optimized language will be distributed in English, Spanish, Portuguese, Chinese, Arabic, or Haitian Creole, based on preferred language identified in the patient profile in an electronic medical records system.

The primary objective of the optimization study is to examine the effectiveness on increasing interest in research of an optimized letter versus a generic letter; an optimized message versus a generic message; and an optimized letter and an optimized message versus a generic letter and a generic message.

The secondary objective of the optimization study is to examine the effectiveness on increasing participation in research of an optimized letter versus a generic letter, an optimized message versus a generic message, an optimized letter and an optimized message versus a generic letter and a generic message.

Eligibility Criteria:
Inclusion Criteria:

* Has an account with the online patient portal
* Has logged into the online patient portal at least once in the past year
* Has not set up a research profile

Exclusion Criteria:

* Currently enrolled in a clinical trial
* Opted out of research
* On active cancer treatment
* Active member of the study team
Comparison of Postoperative Delirium in Elders Anaesthetised With Midazolam and Without Midazolam

This research project is an observational cohort study by prospective chart review of patients that underwent surgery in multi-centers, China, in the years 2020-2022. The purpose of this study is to compare the occurrence of postoperative delirium With Midazolam and Without Midazolam During Non-cardiac Surgery in Elders.

Post operative delirium will be diagnosed using the 3D- CAM(Confusion Assessment Method) which tests for four features with a series of questions. The features include 1) acute onset and fluctuating course,2) inattention,3) disorganized thinking and 4) altered level of consciousness. Diagnosis of delirium is made if features 1 and 2 and either 3 or 4 are present.

The demographic data of the patients,type and site of surgery will be noted. Preoperative hemoglobin, serum electrolytes and blood urea will be recorded. The intraoperative factors like duration of surgery and anaesthesia,use of intravenous fluids ,blood loss, number blood units transfused and opioid use will be studied at the time of surgery. The time to emergence and extubation following the completion of surgery will be noted.

The postoperative factors like postoperative pain, nausea and vomiting, fever,hemoglobin,serum electrolytes and blood urea will be noted.

Preoperative and postoperative pain will be assessed using the numerical rating score on a scale of one to ten.

The association of various preoperative,intraoperative and postoperative factors with POD will be determined.

Eligibility Criteria:
Inclusion Criteria:

Geriatric surgical patients ≥65 years old Underwent elective non-cardiac surgery

Exclusion Criteria:

History of neuropsychiatric diseases including delirium, mental disorders, Parkinson, dementia, etc.; The operation was cancelled due to various reasons after the patient was enrolled; severe liver disease; severe renal dysfunction defined as either having creatinine clearance \< 30 ml/min or being dialysis-dependent; Patients who undergo second operation in a short period; Refused to participate in the study.
A Pilot Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Treatment of Acne Scarring

This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Acne Scarring. The study is being conducted at 2 centers in India. The primary endpoint is change in the Global Acne scarring classification scores from screening to end of the study. The secondary endpoints are Photographic Assessment, Physicians assessment score and Patients self assessment score.


Eligibility Criteria:
Inclusion Criteria:

* Subjects (male and female), aged 18 to 40 years (both inclusive).
* Subject willing to refrain from any other treatment of Acne Scarring during entire study duration.
* Non-pregnant, non-lactating females who agree to use adequate and acceptable methods of contraception from screening and throughout the course of the study.
* Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria:

* Subjects with active infection or active acne.
* Subjects receiving treatment: NSAIDs treatment within the last 7 days prior to the study.
* Subjects with history of connective tissue disease.
* Subjects with metabolic or hematopoietic disorders.
* Subjects with known bleeding disorders such as platelet dysfunction syndrome, thrombocytopenia, hypofibrinogenemia.
* Subjects who have received prior chemotherapy and radiotherapy
* Subjects unwilling to or unable to comply with the study protocol.
* Subjects taking concomitant therapy that might interfere with the study results in the investigator's opinion or participating in another trial in the past 30days
Expanded Access to Provide Selitrectinib for the Treatment of Cancers With a NTRK Gene Fusion

Selitrectinib expanded access is for minor and adult patients with cancer having a change in a particular gene (NTRK1, NTRK2, or NTRK3 gene fusion). The patients are ineligible for an ongoing selitrectinib clinical trial or have other considerations that prevent access to selitrectinib through an existing clinical trial. Expanded access is intended to treat individual patients with different types of cancers with a NTRK gene fusion, including blood cancers, who have previously received tropomyosin receptor kinase (TRK) inhibitor therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cancer with a NTRK1, NTRK2, and NTRK3 gene fusion
* Previous treatment with a kinase inhibitor with known activity on TRK inhibition
* Unable to participate in an ongoing selitrectinib clinical trial
* Medically suitable for treatment with selitrectinib

Exclusion Criteria:

* Currently enrolled in an ongoing clinical study with a TRK inhibitor
Selective Avoidance of Sentinel Lymph Node Biopsy After Neoadjuvant Chemotherapy In HER-2 Positive/Triple Negative Breast Cancer Patients With Excellent Radiologic Response to the Breast and Axilla, Prospective, Multi-center, Single-arm (ASLAN) Study

The aims of this study is to evaluate 5 year recurrence free survival when omit sentinel lymph node biopsy after neoadjuvant chemotherapy in triple negative or HER-2 positive breast cancer patients when physical examination expected complete remission. And radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm.


Eligibility Criteria:
Inclusion criteria

1. 20≤Age\<70
2. undergone neoadjuvant chemotherapy
3. HER-2 or triple negative breast cancer
4. clinical stage T1-3, N0-1, M0 (AJCC 8th)
5. not Inflammatory breast cancer
6. neoadjuvant chemotherapy should be done before surgery(sandwich method is not allowed)

   * least four times anthacycline or taxane-based regimens
   * no axilla lesion progression during chemotherapy
   * no period of adverse response during chemotherapy
7. undergone anti HER-2 therapy in HER-2 positive patient
8. no preoperative anti hormonal therapy
9. no preoperative radiation therapy
10. did not axillary lymph node biopsy before neoadjuvant chemotherapy
11. physical examination expected complete remission. And radiological expected Tumor size ≤ 2cm or non-mass enhancement ≤ 4cm
12. no previous axilla surgery
13. no previous ipsilateral breast surgery for invasive cancer
14. no Pregnancy-associated breast cancer
15. ECOG performance status 0-1
16. Serum or urine b-HCG negative
17. agree to the consent form

Exclusion criteria

1. During pregnancy
2. major depression or taking psychiatric medication
3. significant psychiatric disorder or history of taking antipsychotic drugs
4. any other lymph node metastasis than axillary lesion
5. undergoing total mastectomy
6. do not agree to the consent form
How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units

The purpose of this study is to study the effect of two standard of care sedative medications on sleep stages and total sleep time. The investigators hypothesize that the α2 agonist, dexmedetomidine, will improve sleep quality by increasing N2 and N3 sleep as well as total sleep time when compared to GABA agonists.

This is a single center randomized pilot study comparing the effects of an α2 agonist (dexmedetomidine) versus GABA agonists (propofol or a benzodiazepine) on total sleep time and sleep quality. For the purposes of enrollment and analysis all benzodiazepines used for sedation (mainly midazolam and lorazepam) will be considered equivalent. Patients who are mechanically ventilated and sedated will be enrolled. The initial sedative will be determined by the managing medical team and the medication will be active at the time of enrollment. The patients will then be randomized to either continue their current sedative or be switched to either propofol or dexmedetomidine. PSG data will be collected for up to 96 hours, beginning at enrollment for all patients. The analysis of PSG will not begin until after a 8 hour "washout" period has completed to minimize carryover effect of prior sedatives.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to the medical intensive care unit who require mechanical ventilation and are sedated with a GABA agonist with the expectation of being mechanically ventilated for greater than 24 hours.

Exclusion Criteria:

* Subjects who are less than 18 years
* Subjects who are pregnant (a pregnancy test will be performed on all women of child bearing age)
* Inability to obtain informed consent from the patient or his/her surrogate
* Subjects who are physiologically benzodiazepine dependent, and at risk of withdrawal syndromes
* Subjects with anoxic brain injuries, strokes, or neurotrauma
* Medical team following patient unwilling to change sedation regimen
* Subjects who are moribund and not expected to survive 24 hours or actively withdrawing medical support
* Documented allergy to study medications
* Subjects with advanced heart block at time of screening
* Prisoners
* RASS target of less than or equal to -4 at the time of screening
* PSG equipment unavailable
The Mechanism of Action of Unite Biomatrix in Venous Leg Ulcers

The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, compression therapy alone for the treatment of venous leg ulcers.


Eligibility Criteria:
Inclusion Criteria:

* venous ulcer confirmed w/ duplex ultrasound
* ulcer greater than 6 months duration
* post-debridement, the ulcer size must be \>5cm2
* at least 18 years old
* ABI is between 0.7 to 1.2 and/or one of the following:

  * TcPO2 \> 30mmHg at the ankle
  * Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic)
* able and willing to provide a voluntary written informed consent
* three or fewer ulcers separated by \>3.0 cm distance
* able and willing to attend scheduled follow-up visits and study related exams

Exclusion Criteria:

* greater than 20% reduction in wound size during the first 2 weeks of observation with the investigator
* ulcer with exposed bone or tendon
* clinical infection at the studied ulcer site including cellulitis and osteomyelitis
* ulcer of a non-venous insufficiency etiology
* phlebitis or deep leg vein thrombosis in past 30 days
* arterial bypass in previous 30 days
* severe anemia (Hgb\<8)
* serum albumin \<3.0
* uncompensated congestive heart failure
* renal failure with Creatinine \>2.5mg/dl
* rheumatoid arthritis (and other collagen vascular disease), vasculitis, sickle cell disease, HIV
* severe liver disease as defined by treating physician
* uncontrolled diabetes mellitus determined by treating physician
* malignancy at or near the ulcer site
* any condition judged by the PI that would cause the study to be detrimental to the patient
* known allergy to equine derived tissue
* received another investigational device or drug within 30 days of Day 0
* radiation therapy at the wound site
* chemotherapy or immunosuppressive therapy within 30 days of enrollment
* received another allograft, autograft, xenograft within 30 days of the study
* pregnant or nursing women