cyrilzakka/clinical-trials huggingface dataset:
Chemsex Health Evaluation With Extended Release System for HIV Treatment

CHEERS is an observational cohort for people living with HIV who are actively practicing chemsex and who are switching to CAB + RPV LA after being virologically suppressed on a stable oral ART regimen. This study aim to assess the impact of increased patient engagement associated with this LA regimen on linkage to psychosocial care and on global health outcomes, such as quality of life, substance use, treatment satisfaction and virological control.

Eligible participants will need to be currently out of care for psychosocial counselling and will need to express the wish to switch to CAB + RPV LA. The participants will be followed in this study for 11 months from their first LA administration, according to the schedule of injections. In addition to standard of care procedures, such as blood draw and physical exam, patient reported outcome questionnaires will be administered at certain visits and a semi-directed interview will be conducted at the beginning and at the end of the study. CAB + RPV LA will be used in line with the Canadian monography.


Eligibility Criteria:
Inclusion Criteria

1. Man, trans-woman or gender diverse person who was assigned male at birth and is over 18 y.o.
2. Actively practices chemsex, as assessed by self-reported use of substances (methamphetamine, GHB/GBL, ketamine and mephedrone) as a mean of prolonging sexual relations, intensifying sexual pleasure and/or exploring one's sexual subjectivity at least once in the last month prior to screening\*.
3. Living with HIV-1 and virologically suppressed (plasma HIV RNA \< 50 c/ml) on stable oral ART regimen for at least one month prior to screening.
4. Not currently receiving psychosocial support, either on site or outside of the clinic, as evaluated by an absence of self- reported psychosocial consultation in the last 3 months prior to screening.
5. Participant is capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
6. Participant is able to locally source Cabenuva, as this product is not provided in the context of this study.

   * If a patient only tried it once and it occurred in the last month prior to screening, we will consider that they meet the inclusion criteria, although we will focus on enrolling patients with a documented history of regular substance use, as pre-identified by chart review.

Exclusion Criteria

1. History or presence of allergy, resistance or intolerance to Cabotegravir or Rilpivirine, or drugs of their class.
2. Exposure to an experimental drug or experimental vaccine within 30 days prior to first dose of study treatment.
3. Alanine aminotransferase (ALT) 5 times the upper limit of normal (ULN); or ALT 3xULN and bilirubin 1.5xULN (with \>35% direct bilirubin).
4. Participant has estimated creatine clearance \<30mL/min per 1.73 m2
5. Any concomitant condition or medication prohibited by local prescribing information.
6. Any condition judged by the investigator that may interfere with the study or the patient's well being if they were being enrolled.
Effect of Ranolazine on Gastrointestinal Motor Function and Pain in Patients With IBS-D

Will Ranolazine improve bowel function and abdominal pain in human subjects with IBS-D?

This is a randomized double-blind placebo-controlled pilot study that will use validated bowel questionnaires to evaluate the effects of ranolazine administered orally twice daily in patients with diarrhea predominant IBS (IBS-D). The study will consist of a 2 week run in period, followed by 4 weeks of treatment period with oral ranolazine 1000 mg twice daily. Primary endpoint of the study will be the average Bowel Symptom Scale (BSS) scores for diarrhea and adequate relief of IBS pain and discomfort are secondary end points.

Eligibility Criteria:
Inclusion Criteria

* Males and non-pregnant, non-breastfeeding females with established diagnosis of IBS-D by modified Rome III criteria (Abdominal Pain Intensity: weekly average of worst daily score of \>3.0 on a 0 to 10 point scale and Stool Consistency: at least one stool with a consistency of Type 5, 6 or 7 Bristol stool score on at least 2 days per week)
* 18-70 years old
* U.S. resident
* English-speaking (to provide consent and complete questionnaires)

Exclusion Criteria

* Structural or metabolic diseases/conditions that affect the gastrointestinal system
* Unable to withdraw the following medications 48 hours prior to the study:

  * Drugs that alter GI transit including Lomotil, and bile acid binders such as cholestyramine, prokinetics (e.g. metoclopramide, cisapride and erythromycin), narcotics (e.g. oxycodone, morphine) and anticholinergics (dicyclomine, hyoscyamine).
  * Analgesic drugs including narcotics, NSAID, cyclooxygenase-2 ( COX2) inhibitors (celecoxib, rofecoxib, and valdecoxib)
  * GABAergic agents (baclofen)
  * Benzodiazepines (e.g. lorazepam, alprazolam, and diazepam). Low stable doses of thyroid replacement, estrogen replacement, and low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.
* Unable to withdraw the following medications, which are contraindications of ranolazine:

  * Strong Cytochrome P450, Family 3, Subfamily A (CYP3A) inhibitors (e.g. ketoconazole, clarithromycin, and nelfinavir)
  * CYP3A inducers (e.g. rifampin, phenobarbital, St. John's wort)
* Female subjects who are pregnant or breastfeeding.
* Current symptoms of severe depression, as measured by Hospital Anxiety And Depression Scale ( HADS) score greater than 15.
* Clinical evidence (including physical exam, ECG, laboratory studies and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
* The Corrected QT Interval (QTc) \> 490 msec.
* Active alcoholics not in remission or known substance abusers.
* Liver cirrhosis
* Patients with clinically significant hepatic disease.
* Major cardiovascular events in the last 6 months.
* Participation in another clinical trial (within 30 days).
* Incarcerated.
Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at University of Virginia (UVa)

The purpose of this study is to demonstrate the feasibility of using the transnasal endomicroscopy (TNE) platform, using intestinal potential difference (IPD) and microbiome brush to evaluate the intestine of unsedated infants.

A total of fifteen (15) subjects, infants 6 months of age to 48 months of age will be enrolled in this study.

While the subject is awake and unseated, a catheter with optical coherence tomography (OCT) imaging technology will be introduced transnasally. Images will be acquired while the tube is moved through the subject's GI tract. After imaging is complete, accessory device(s) may be threaded through the catheter to collect samples of the gut microbiome and/or measure intestinal potential difference.

Eligibility Criteria:
Inclusion Criteria:

* 6 to 48 month old infants that can follow fasting requirements

Exclusion Criteria:

* Any infant under 6kg of weight since this is the minimum weight for 6.5 F nasogastric (NG) tube
* Any infant whose nasal passage cannot reasonably accommodate a 6.5 French nasoduodenal catheter.
* Any infants with absolute or relative contraindications to transnasal tubes:

  1. severe midface trauma and recent nasal, throat, or esophageal surgery.
  2. Esophageal varices, esophageal stricture, and alkaline ingestion
  3. Congenital anatomical defects affecting the gastrointestinal tract, most specifically cleft lip and/or cleft palate.
* Any infant with absolute or relative contraindication to a duodenal biopsy:

  1. post bone marrow transplant
  2. coagulation abnormalities
Clinical Performance of MTA Cavity Lining in the Treatment of Deep Caries Lesions

Aim of this clinical study is to compare the clinical success of two lining materials regarding the maintenance of pulp vitality in the treatment of deep caries lesions over 4- years.

A hundred permanent premolar and molars with deep caries lesions without pulp involvement (aged between 18 and 30 years) in 73 patients were randomly divided into the following groups: calcium hydroxide cement (Ca(OH)2) (Dycal, Dentsply/Caulk, Dentsply International Inc, Milford, DE, USA) group and mineral trioxide aggregate (MTA) (Dentsplay, Tulsa Dental, Johnson city, USA) group. Final restoration with a resin-based composite (Gradia Direct Posterior, GC, Tokyo, Japan) in a single session was performed. The following-up period was 6-, 12-, 24-, 36- and 48-months. Two calibrated examiners performed the clinical examination of the pulpal symptoms

Aim of this clinical study is to compare the clinical outcomes of mineral trioxide aggregate (MTA) cavity lining with calcium hydroxide (Ca(OH)2) regarding the maintenance of pulp vitality in the treatment of deep caries lesions over 4- years.

Materials and Methods: A hundred permanent premolar and molars with deep caries lesions without pulp involvement (aged between 18 and 30 years) in 73 patients were randomly divided into the following groups: calcium hydroxide cement (Ca(OH)2) (Dycal, Dentsply/Caulk, Dentsply International Inc, Milford, DE, USA) group and mineral trioxide aggregate (MTA) (Dentsplay, Tulsa Dental, Johnson city, USA) group. Final restoration with a resin-based composite (Gradia Direct Posterior, GC, Tokyo, Japan) in a single session was performed. The following-up period was 6-, 12-, 24-, 36- and 48-months. Two calibrated examiners performed the clinical examination of the pulpal symptoms. The data will be analyzed with Pearson chi-square, Fisher exact and logrank statistics tests (p \< 0.05). The Kaplan-Meier survival analysis will be conducted to reveal the survival rate.

Eligibility Criteria:
Inclusion Criteria:

1. Primary deep caries lesion with risk of pulp exposure (radiograph depth reaching 3/4 of the dentin).
2. Restorable by direct restoration and functional permanent posterior teeth,
3. Positive response to electric pulp testing and negative response to thermal testing.

Exclusion Criteria:

1. Two or more cuspal loss 2. Caries beneath the gingival margin 3. Spontaneous pain history 4. Presence of any periapical pathology 5. Immature teeth with open apex 6. Pathologic mobility

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A Multi-center Registry Study: The Follow-up the Complications for Trans-vaginal Mesh Surgery

This is a multi-center, prospective, observational, hospital-based registry of pelvic organ prolapse(POP) patients who having trans-vaginal mesh implantation with 12 month and 36 month follow-up.To investigate the incidence of postoperative complications according to the International Urogynecological Association/International Continence Society (IUGA/ICS) complication classification system(the Category- Time-Site(CTS) coding).

Patients who undergo pelvic floor reconstructive surgery with trans-vaginal mesh for the cure of pelvic organ prolapse (POP) between June 2019 and December 2022 from 41 centers across the country are going to be prospectively collected. The study is designed to report the clinical data，outcomes and complications of transvaginal mesh surgery in China. The information gathered will identify the incidence rate of complications, especially mesh exposure/erosion, in Chinese women and whether published, professional guidelines on POP surgical treatment as well as mesh complications management are being applied appropriately. Findings from this registry may help in knowing the current status of transvaginal mesh use in China as well as identify issues that may affect the surgical outcome and complications occurrence. Based on the registry study, clinical practice on the management of transvaginal mesh implantation including selection patients, pre- and post-operative evaluation and complications surgical database will be established.

The follow-up process starts after patients have completed the operation; thus, our study does not affect patients' choice of surgical method.

Eligibility Criteria:
Inclusion Criteria:

1） Patients who undergo the pelvic reconstruction surgery with trans-vaginal mesh; 2) Patient is mentally able to understand the nature, aims, or possible consequences of the clinical investigation; 3）Willing to participate in 36 months of longitudinal follow-up and able to provide written informed consent. Willing to provide an email address and complete questionnaires on we-chat, either in clinic or elsewhere when they have access to the internet.

Exclusion Criteria:

* 1) Currently pregnant at enrollment;
* 2) Physically or mentally unable to participate in up to 36 months of follow-up;
* 3) Desires other surgical management of POP other than trans-vaginal mesh.
Venous Thrombosis After Removal of Central Venous Catheter

Insertion of intravenous catheter is a very common operation in patients in the general intensive care unit. These catheters are used for a variety of purposes - administration of inotropics/pressors, intravenous nutrition, concentrated electrolytes and performing dialysis.There are several known complications of central venous catheter insertion, such as thrombosis and pulmonary embolism. In a literature review, there are no clear data regarding the rate of intravenous thrombosis in patients after removal of a central venous catheter. These findings are often discovered randomly, when the patient undergoes imaging for a different indication. There is no recommendation for an active search for intravenous thrombi at the catheter insertion sites in these patients, and it is not entirely clear whether it is mandatory to administer anticoagulant treatment in these patients if thrombi are randomly discovered at the catheter insertion sites.

In this study, we aim to check the proportion of patients who developed thrombosis at the central catheter insertion sites after its removal, to check whether there are catheter insertion sites that are at a higher risk of developing thrombosis than other sites, and to check whether there are predictive characteristics for the development of this type of thrombosis.


Eligibility Criteria:
Inclusion Criteria: Patients who were admitted to the intensive care unit and had a central catheter inserted during their stay in the unit for any reason, and whose central catheter was removed during their stay in the general intensive care unit.

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Exclusion Criteria:Patients whose insertion or removal of the central catheter did not occur during the hospitalization in the intensive care unit, patients who were treated with full anticoagulation in the intensive care unit.

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Induction of Puberty With 17-beta Estradiol in Girls With Turner Syndrome

This trial is conducted in Europe. The aim of the trial is to induce normal pubertal development in girls with Turner Syndrome in accordance with that of their peers and their individual state psychosocial maturation.


Eligibility Criteria:
Inclusion Criteria:

* Turner Syndrome
* Treatment with growth hormone
* Bone age minimum 12 years and maximum 14 years
* Clear signs of ovarian insufficiency
* Well documented growth rate during the last 12 months

Exclusion Criteria:

* Signs of spontaneous puberty
* Known or suspected hypersensitivity to trial product
* Acute or chronic liver disease
* Previous treatment with estrogen
* Undiagnosed abnormal genital bleeding
* Known thyroid diseases not adeadequately treated
* Porphyria
Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19

In the context of the COVID-19 pandemic, concerns of the risk of infection may lead to fear, anxiety or psychological disorders that may become generalised and long-lasting, corresponding to post-traumatic stress disorder (PTSD). PTSD generally occurs in circumstances such as terrorist attacks, hostage-taking, bombings, aggression, accidents... The current health crisis also represents an increased risk of PTSD.

After the first moments of stress, the illness becomes more diffuse: personality change (introverted/extraverted), sleep disorders, heart problems, hypervigilance reaction, agoraphobia, symptoms of reminiscence, irritability, decreased concentration, memory loss... In some people, PTSD can lead to more disabling problems such as (crowd) avoidance.

In order to help patients with PTSD, clinical psychology offers therapeutic approaches which, starting from a debriefing with the patient, provide supportive therapy which (i) reassures by providing information on the symptomatology, in order to play down the present state of mind, (ii) allows for the expression of what was experienced during the event, (iii) initiates a process of elaboration of the trauma through transference.

A study initiated at the François Baclesse Centre during the first confinement, which included 735 patients from April to June 2020, made it possible to assess the impact of the pandemic linked to COVID-19 on the care of cancer patients treated in day hospitals, but also to evaluate the PTSD experienced by patients, sleep difficulties, quality of life, cognitive complaints and confinement conditions using validated questionnaires. This study showed that 21% of patients had proven PTSD and 23% had insomnia problem.

This study proposes to evaluate the value of adapted psychological care for patients with PTSD in relation to the pandemic on the improvement of PTSD, as well as on resilience, quality of life and sleep.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Patient treated or followed up for a solid tumour at the François Baclesse Centre
* Patient with a score suggesting moderate or high posttraumatic stress symptoms (IES-R score ≥ 24) related to the COVID-19 epidemic
* The patient's state of health is compatible with the programme: psychological care for 6 months.
* Information note signed by the patient
* Any associated geographical, social or psychopathological conditions that might compromise the patient's ability to participate in the study

Exclusion Criteria:

* Patient with no symptoms suggestive of moderate or high post-traumatic stress (IES-R score \<24)
* Patient deprived of liberty or under guardianship
* Patient already receiving psychological care
* Patient whose diagnosis of the disease was made within one month prior to the proposal for participation
Tacrolimus Exposure in Kidney Transplantation

Using CDW data from 5 tertiary hospitals in Korea, this study identify the optimal range of trough level that can prevent adverse outcome in the early periods after transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Renal transplant recipients between January 1, 2005 through December 31, 2014 in one of the five participating centers
* Patients receiving oral tacrolimus as one of the main immunosuppressant at the start of the defined cohort time (i.e. at post-transplant 2 months for the analysis of 1-year outcomes and at post-transplant 12 months for the analysis of 6-year outcomes)

Exclusion Criteria:

* Graft failure occurring within the first 2 month of transplantation
* Mortality of any cause occurring within the first 2 month of transplantation
* Patients moving centers during the study period
* Patients who have received other organ transplantation(s) besides renal transplantation in the defined period
Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Chinese Healthy Volunteers

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects.

This is an open-label study that will be conducted at a single site in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. The total duration of study participation is up to 6 weeks for each subject. Subjects will complete a follow-up visit at Day 28 after the dosing.

Eligibility Criteria:
Inclusion Criteria:

* Must be healthy males or females between 18 to 45 years old, inclusive
* Must have a body mass index (BMI) of 19 to 25 kg/m2, inclusive, and a minimum body weight of 50.0 kg

Exclusion Criteria:

* History of any clinically significant laboratory abnormalities, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
* Female subjects who are pregnant or breastfeeding
* Any previous treatment with Human Albumin Interferon fusion protein
Prolonged Exposure to Doxorubicin in Patients With Glioblastoma Multiforme and Diffuse Intrinsic Pontine Glioma

The standard therapy of glioblastoma (GBM) consists of gross total resection followed by focal irradiation to the tumor bed with concomitant and adjuvant temozolomide (TMZ). The association of valproic acid and TMZ during radiotherapy improves survival of GBM. Preclinical studies suggested that doxorubicin had a strong antineoplastic activity against human gliomas. Moreover, some studies showed that the continuous infusion of anthracyclines in patients with solid tumor ensured a better safety profile compared with bolus administration.

Based on these findings, the purpose of this study is to evaluate safety and efficacy of prolonged administration of doxorubicin in combination with radiotherapy, temozolomide and valproic acid in pediatric and adult patients with newly diagnosed GBM and diffuse intrinsic pontine glioma (DIPG).


Eligibility Criteria:
Inclusion Criteria:

* Males and females patients, aged \>3 years and \< 30 years;
* Newly diagnosed of GBM, DIPG, diffuse brainstem glioma, diffuse spinal glioma, bilateral thalamic glioma, gliomatosis cerebri, anaplastic astrocytoma;
* Patients undergone either surgery or biopsy only;
* No prior chemotherapy and/or radiotherapy;
* Life expectancy ≥ 4 weeks;
* Karnofsky/Lansky ≥ 40 %;
* Written informed consent obtained from the patient/parents or legal representative;
* Adequate hematological function (leucocyte ≥ 2.0 x 10\^9/l -Hemoglobin ≥ 10 g/dl - platelet ≥ 50 x 10\^9 /l);
* Adequate liver function (total bilirubin ≤ 2.5 x ULN - ALT/AST ≤ 5.0 x ULN);
* Adequate renal function (serum creatinine ≤ 1.5 x ULN);
* Adherence to trial treatment and compliance with the protocol

Exclusion Criteria:

* Any disease or condition that contraindicates the use of the study drug (es. serious mental retardation, brain palsy, congenital syndrome, cardiomyopathy)
* Prior anti-cancer therapy
* Pregnancy or breastfeeding
* Non adequate contraception