cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a Multi-level School Intervention for LGBTQ Youth

Efficacy of a Multi-level School Intervention for LGBTQ Youth

The goal of this R01 grant is to test the efficacy of a theoretically informed, LGBTQ-affirming intervention (Proud \& Empowered; P\&E) alongside a school climate intervention (Make Space).

Sexual and gender minority adolescents (SGMA) experience victimization in schools at much higher rates than their peers, and although SGMA experience disparities in behavioral health outcomes compared to their heterosexual peers, interventions are scarce.

The investigators P\&E intervention aims to allow youth participants to discuss their experiences of bullying and victimization, to build coping skills and to plan stress management strategies, while the investigators Make Space intervention is an indirect, environmental strategy aimed at improving overall school climate. The investigators goal will be achieved by completing three specific aims: 1) Determine participant-level efficacy of the intervention in an RCT with 24 schools (6-10 schools each year over 4 years); 2) Determine the school-wide intervention effects on (a) reporting of minority stress and behavioral health outcomes among all SGMA students and (b) perceptions of school climate (norms, attitudes, beliefs, bullying behaviors toward SGM youth, policies) among all students, and; 3) Examine factors that may affect intervention success (e.g., fidelity of implementation, barriers or facilitators to implementation, school or student characteristics) to prepare the intervention for future dissemination. This intervention has been tested in a previous, smaller, Feasibility study with 4 high schools.

Eligibility Criteria:
Inclusion Criteria:

* LGBTQ student in one of 24 high schools

Exclusion Criteria:

* Not meeting inclusion criteria
The Efficacy of Olfactory Training Intervention on Olfactory and Other Non-motor Symptoms in PD

To explore the efficacy of olfactory training on olfactory and other non-motor symptoms in PD.


Eligibility Criteria:
Inclusion Criteria:

1. PD was diagnosed according to the criteria of Movement Disorders and Parkinson Disease Group of Chinese Society of Neurology of Chinese Medical Association.
2. Olfactory score was 1 standard deviation lower than the corresponding age norm;
3. no medication plan in the past four weeks or no change in medication plan in the past four weeks, which can be maintained until the end of the experiment; 4.40-75 years old, with normal vision, hearing and language understanding and expression ability;

5.Good cooperation of patients

Exclusion Criteria:

1. Parkinson\&#39;s syndrome and Parkinson\&#39;s plus syndrome caused by cerebrovascular disease, encephalitis, trauma, drugs, etc.;
2. Neuropsychiatric diseases that may affect the sense of smell, such as depression, anxiety, schizophrenia, etc.;
3. History of nasal disease or surgery, such as rhinitis, sinusitis, nasal septum deviation, etc. Upper respiratory tract infection in the past 3 weeks;
4. Long-term smoking and occupations that inhale chemical irritants for a long time.
Stem Cell Transplantation With Identical Donors for Patients With Sickle Cell Disease

This protocol studied the effect of administration of a myeloablative pretransplant preparative regimen followed by an infusion of donor stem cells in children with severe sickle cell disease. The donor graft consisted of bone marrow or cord blood derived from a genetically matched sibling.

The primary aim of the study was to evaluate how well the donated cells migrated to the bone marrow and begin producing healthy red blood cells, white blood cells and platelets (engrafted), how well the recipients immune system recovered, and assess any regimen related toxicities including a potentially life-threatening transplant related complication called graft-versus-host-disease or GVHD.

The secondary objectives of this protocol evaluated the effect of this transplant procedure on the subsequent clinical course of patients with severe SCD. Specifically, to determine whether pre-transplant organ dysfunction (brain, heart, lung, kidney, liver, spleen, etc) resultant from sickle hemoglobinopathy can be reversed following this particular transplant procedure.

Eligibility Criteria:
Inclusion criteria:

Diagnosis of severe' disease is denoted by one of the following:

* Previous central nervous system vaso-occlusive episode with or without residual neurologic findings or
* Frequent painful vaso-occlusive episodes with significant interference with normal life activities and which necessitates chronic transfusion therapy or
* Recurrent SCD chest syndrome events which necessitate chronic transfusion therapy.

Exclusion criteria:

* Patient with SCD chronic lung disease greater than or equal to stage 3
* Patient with severe renal dysfunction defined as creatinine clearance \< 40 ml/min/1.73m2.
* Patient with severe cardiac dysfunction defined as echocardiogram shortening fraction \< 25%.
* Patient with HIV infection.
* Pregnant or lactating.
* Patient with unspecified chronic toxicity that in the opinion of the Principal Investigator is serious enough to detrimentally affect the patient's capacity to tolerate SCT.
* Patient or patient's guardian(s) unable to understand the nature and risks inherent in the BMT process
Clinical Study of Treatment of Acute Spinal Cord Injury by Near Infrared Light Irradiation

The purpose of this study was to observe the therapeutic effect of near-infrared light irradiation on the treatment of acute spinal cord injury in humans, and whether it can promote the recovery of neurological function. Half of the patients underwent laminectomy and decompression surgery, and the other half of the patients were implanted with irradiated fibers for irradiation after surgery.

The annual incidence of spinal cord injury has increased year by year, and there is currently no effective treatment.

Near-infrared light has been widely used in clinical medicine because of its bio-stimulating effect, convenient use, harmless to the body, easy to be accepted by patients, and convenient for clinical promotion. The near-infrared light biostimulation effect can enhance the activity of various enzymes, inhibit inflammatory cells, inhibit neuronal apoptosis, and promote nerve regeneration. It has been widely confirmed and widely used in the rehabilitation of central nervous system and peripheral nerve injury. However, the position of the spinal cord is deep, and the depth of illumination used by laser treatment equipment is generally difficult to reach.

The implantable 360° scattering fiber the investigators developed was implanted in the surgical site together with the drainage tube for irradiation treatment without additional patient damage.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as acute spinal cord injury (ASIA grade A-C) (thoracic segment) requiring surgical laminectomy
* The patient determined by the investigator to be eligible for the illuminating fiber implanted in this clinical trial
* The patient fully understands the content and requirements of this clinical trial and is able to complete the follow-up according to the time specified in the protocol
* Voluntary participation in clinical validation and signing informed consent

Exclusion Criteria:

* The patient has a systemic infection or a local infection at the target surgical site
* The patient has more than 2 segments of spinal cord injury, and the vital signs are unstable
* A patient with a malignant tumor that does not involve the target surgical site
* Patient life expectancy is less than one year
* Pregnant or lactating women
* The patient is too obese, BMI ≥ 40
* Patients with other systemic diseases who are using corticosteroids, or patients with growth factors, or long-term use of non-steroidal anti-inflammatory drugs
* Patients have a history of endocrine diseases affecting bone metabolism (such as diabetes, metabolic bone disease, etc.) or autoimmune diseases (such as multiple sclerosis)
* Alcohol abuse within one year (average daily alcohol consumption \> 40g, equivalent to 50ml alcohol 50ml, or smoking ≥ 40 / day, or drug abusers)
* Participating in other drug or device clinical trials
Use of a Phosphodiesterase Type 5 Inhibitor to Improve Anabolic Resistance in Older Adults

This study will be the first demonstration of the utility and feasibility of Phosphodiesterase Type 5 inhibitor as an effective pharmacological therapy for improving anabolic resistant states.


Eligibility Criteria:
Inclusion Criteria:

* Ages 60-75 yrs
* Recently prescribed 5mg of tadalafil daily for clinical purposes

Exclusion Criteria:

* History of diabetes
* history of hypotension including orthostatic hypotension
* History of malignancy or chemo/radiation therapy in the 6 months prior to enrollment
* History of short gut syndrome, gastrointestinal bypass/reduction surgery (Lap band, gastric sleeve, etc.)
* Subjects who cannot refrain from using protein or amino acid supplements for 7 days prior to Visit 2 and 3.
* Alcohol consumption of ≥ 5 units/servings per day
* Concomitant use of

  * oral or injectable corticosteroids
  * testosterone, insulin like growth factor-1, or similar anabolic agent
  * riociguat (Adempas)
  * nitroglycerin
  * isosorbide dinitrate (Isordil)
  * isosorbide mononitrate (Imdur, Monoket)
  * doxazosin (Cardura)
  * prazosin (Minipress)
  * terazosin (Hytrin)
* Any other disease or condition that would place the subject at increased risk of harm if they were to participate, at the discretion of the study physician
Histological Evaluation in the Efficacy of GentleWave in Root Canal Pulp Tissue Debridement and Disinfection of Difficult to Reach Areas in Mandibular Human Molars II. An In-vivo Study.

The purpose of this study is to understand and learn better the efficacy of GentleWave and obtain histological evidence of the efficacy of this new technology done in-vivo


Eligibility Criteria:
Inclusion Criteria:

* Only teeth that patient decided to have the extraction done instead of having any other type of dental treatment and teeth extracted at patient's petition.

Exclusion Criteria:

* Teeth with root fractures or previously root canal treated teeth.
* Teeth with severe loss of structure
* Children
Intrabone Cord Blood Transplantation

The purpose of this study is to evaluate the viability of intrabone administration of umbilical cord blood as allogenic transplantation for the treatment of hematologic malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Hematological malignancies
* Indication of allogenic transplantation
* No suitable donor (related/unrelated)
* No suitable cord blood unit with enough cellularity for standard transplant
* Written informed consent

Exclusion Criteria:

* ECOG \> 2
* Co-morbidities
* HIV positive serology
* Pregnancy or breastfeeding
* Psychiatric illness
Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness

In this study, the investigators aim to determine the effects of age, sex, history of ocular surgery and contact lens use, and ocular surface and meibomian gland parameters on the lipid layer thickness (LLT) in normal subjects and patients with dry eye syndrome. Patients with dry eye syndrome and subjects with a healthy ocular surface will be enrolled. All participant will underwent LLT measurement with a LipiView interferometer, tear meniscus height measurement using optical coherence tomography, tear film break-up time (TBUT) determination, corneal and conjunctival staining, Schirmer's test, examination of the lid margins and meibomian glands, and assessment using the Ocular Surface Disease Index(OSDI) questionnaire.


Eligibility Criteria:
Inclusion Criteria:

1. age over 19 years old, Patients with dry eye syndrome and normal subjects

Exclusion Criteria:

1. patients less than 18 years of age and patients with histories of ocular surgery within 3 months; ocular injury; and ocular diseases such as ocular infection, allergy, and autoimmune disease; and patients with the use of a punctal plug or topical ocular medications other than artificial tears.
2. Patients who used artificial tears were instructed not to apply them for at least 12 hours 99 before the examinations
Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly

122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a night of melatonin, half got a placebo.


Eligibility Criteria:
Inclusion Criteria:

* Age over 65 admitted through the emergency department to an internal medicine service in London, Ontario, Canada.

Exclusion Criteria:

* Life expectancy less than 24 hours,
* Unable to communicate in English,
* Unable to take oral medications,
* Intracranial bleed or known seizure disorder,
* Markedly sub or supra-therapeutic INR while on warfarin, OR
* A known allergy to study tablet ingredients.
A Study of Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Treated With T-cell Redirectors Outside of Clinical Trials

The purpose of this study is to describe the use of teclistamab/talquetamab in the treatment of patients with RRMM outside of clinical trials.


Eligibility Criteria:
Inclusion Criteria:

* Have a documented diagnosis of multiple myeloma
* Received the first dose of teclistamab on or before 31 December 2022, regardless of the duration of teclistamab treatment (REALiTEC cohort 1) OR Received the first dose of teclistamab from 01 January 2023 to 31 December 2024, inclusive, regardless of the duration of teclistamab treatment (REALiTEC cohort 2) OR Received the first dose of talquetamab on or before 31 December 2023, regardless of the duration of talquetamab treatment (REALiTAL cohort). Participants who received both teclistamab \& talquetamab can be included in both REALiTEC and REALiTAL cohorts
* Received at least one dose of teclistamab/talquetamab
* Provision of a patient-signed informed consent form (ICF), or an ICF waiver for deceased patients as applicable based on country/site-specific requirements

Exclusion Criteria:

* To be excluded from REALiTEC cohorts if received teclistamab as part of an interventional clinical trial
* To be excluded from REALiTAL cohort if received talquetamab as part of an interventional clinical trial
* Participants who have received teclistamab as part of a Janssen pre-approval access program are excluded from the REALiTEC Cohort 2
Pilot Study of Ketamine in Adults With Obsessive-Compulsive Disorder (OCD)

In this study investigators are studying the effects of a drug called ketamine on the symptoms of Obsessive-compulsive disorder (OCD).

Obsessive-compulsive disorder (OCD) is a common psychiatric illness that affects up to 2-3% of the population. People with OCD experience anxiety-provoking, intrusive thoughts, known as obsessions, and feel compelled to perform repetitive behaviors, or compulsions. The only medications proven effective for OCD are serotonin reuptake inhibitors (SRIs), but even with SRI treatment, most patients continue to experience significant OCD symptoms, impaired functioning, and diminished quality of life. Recent evidence suggest that a different neurotransmitter, glutamate, may contribute to the symptoms in OCD. Medications that target glutamate hold promise for ameliorating symptoms for those patients continuing to suffer from OCD. In this study the investigators are recruiting patients to receive the drug ketamine, which is thought to modulate the neurotransmitter glutamate through the N-methyl-D-aspartate (NMDA), in a 2-week placebo controlled study.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-55
* Physically healthy and not currently pregnant
* Primary Diagnosis of OCD
* Sufficient severity of symptoms
* Able to provide consent

Exclusion Criteria:

* Psychiatric conditions that make participation unsafe
* Currently on psychotropic medication
* Medical conditions that make participation unsafe
* Allergy to ketamine
* Any metal in the body
Transcranial Doppler (TCD) Ultrasound and Cognition in Cerebral Vascular Disease. (SUNRISE)

This study aims to contribute to the identification of factors that may be predictive of cognitive function and to provide data on cerebral hemodynamic in ischemic and haemorrhagic stroke. This study will prospectively study cerebral autoregulation, neurovascular coupling and microembolic signs in cerebrovascular patients with ischemic and haemorrhagic stroke and its relationship with cognitive function and functional recovery


Eligibility Criteria:
Inclusion Criteria:

* Minimum age limit: 18 years
* Patients with intracerebral haemorrhages; Patients with ischemic stroke of atherosclerotic, cardioembolic and embolic etiology from an unknown source;
* Previous mRS equal or more than 4;
* National Institutes of Health Stroke Scale (NIHSS)≤20 at admission;
* IQCODE final score\&amp;amp;lt;3.0

Exclusion Criteria:

* History of dementia or other central nervous system disease associated with cognitive impairment;
* Absence of adequate temporal bone window for Transcranial Doppler monitoring;
* Patients with a large cerebral infarct (greater than on third of the middle cerebral artery territory) or a strategic infarct (paramedian thalamus, medial frontal cortex, or hippocampus) evaluated in the 24 hours-CT;
* Average life expectancy less than 1 year for a different cause of cardiovascular disease;
* Patients with intracranial vascular malformation, intracranial venous thrombosis, head trauma or tumour and haemorrhagic transformation within an infarct;
* Serious kidney and systemic diseases;
* Active cancer patients;
Effects of an Exercise Program for Nursing Home Patients With Dementia

The purpose of this study is to investigate the effect of an exercise program on nursing home patients with dementia.

The intervention group will be exercising one hour twice a week for 12 weeks. The participants will be doing intensive strength exercises and challenging balance exercises in groups of 4-6. Two physical therapists will be leading the intervention group. The control group will be meeting at the same frequency. Groups of 4-6 will be lead by an occupational therapist. The participants will be doing relaxation exercises, listen to music and social activities such as board games or indoor bowling.

The investigators will carry out three test periods:

* Baseline testing before intervention start
* Post test after 12 weeks of intervention
* Follow-up 12 weeks after post test.

The testing will comprise:

* Physical tests carried out by physiotherapists
* Questionnaires concerning mental health and ADL (activities of daily living)
* Cognition tests
* Cortisol in saliva

Eligibility Criteria:
Inclusion Criteria:

* \>55 years old
* Living in nursing home
* Able to stand with help from max 1
* Able to walk 6 meters with or without walking aid

Exclusion Criteria:

* Medically unstable
* Longterm psychotic
* Severe communication problems
Early and Intermittent Antiretroviral Therapy in Naive HIV Infected Adults

The primary objective of the trial is to assess the ability of an early and intermittent antiretroviral therapy in maintaining an immunological stability in antiretroviral naive HIV infected adults, to offer a potential alternative strategy to differed and continuous antiretroviral treatment.This is a 2-year phase II, open-label, multicentric "proof of concept" trial. The patients included are treated following a pulse-therapy scheme, i.e. 6-month periods with once daily boosted-PI based therapy in alternance with 6-month periods without antiretroviral therapy. The preferentially recommended treatment of the study is atazanavir boosted with ritonavir, associated with a fixed combination of abacavir and lamivudine or emtricitabine + tenofovir.The patients are closely followed to assess the efficacy and the tolerance of the strategy, with clinical, biochemical, immunological, virological and pharmacokinetic evaluations.


Eligibility Criteria:
Inclusion Criteria:

* adult confirmed HIV-1 infection
* no previous treatment with antiretroviral drugs or interleukin-2
* CD4 count ≥ 500/mm3
* no active opportunistic infection
* written informed consent

Exclusion Criteria:

* non barrier contraception in women of child bearing potential, pregnant or breastfeeding woman, pregnancy project within the next 2 years
* HIV-2 infection (with or without HIV-1), recent HIV primary infection, resistance to trial drugs at study entry, Ag HBs+, HCV requiring specific therapy
* previous history of cerebrovascular accident or coronary heart disease, splenectomy
* previous CD4 count \< 400/mm3
* CD4 percentage \< 15%
* hemoglobin \< 8 g/dl, neutrophils \< 750/mm3, platelets \< 100.000/mm3, creatinine clearance \< 50 ml/mn, AST or ALT or total bilirubin \> 3 ULN
Effects of Tribulus Terrestris in Postmenopausal Women With Hypoactive Sexual Desire Disorder

Hypoactive Sexual Desire Disorder ( HSDD ) is very common in postmenopausal women due to a reduction in circulating androgen levels. The aim of this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with HSDD.

Hypoactive Sexual Desire Disorder ( HSDD ) is the most prevalent female sexual dysfunction in society mainly in postmenopausal women, and is strongly linked to the quality of life of women . The androgen hormones decline over age in the premenopausal period, more sharply after menopause. Tribulus terrestris is a plant native to India , recommended in the treatment of infertility , low libido and impotence . Its main active ingredient is the protodioscin , which has been attributed to an increase in testosterone levels and improved sexual function . The aim of this study is to evaluate the effects of Tribulus Terrestris in premenopausal women with HSDD .

Eligibility Criteria:
Inclusion Criteria:

* at least one year after last menstrual period
* with no use of hormonal replacement therapy within the last 3 months
* without any medication, drugs or alcohol.
* Healthy patients without systemic or psychiatric disease

Exclusion Criteria:

* Patient smoker (10 cigarettes per day).
* Patients with blood pressure \> 160/90 mm Hg.
* Patient with breast or endometrial carcinoma.
* Patients with a history of myocardial infarction.
* Patient with Diabetes.
* Patient with vaginal bleeding from any source.
* Patients with hepatic injury.
* Patients with active thrombophlebitis or thromboembolic disorders recent
* Patients with interpersonal relationship problems with your relationship or partner
* Patients with sexual problems from your partner
Measuring Quality of Life of Poly-amide Complete Dentures

Polymethyl methacrylate have been used since 1937 as a gold standard for a denture base material because of its several advantages as; good esthetics, adequate strength, easy repair and simple processing techniques. As any material it has some problems as polymerization shrinkage, low impact and flexural properties and low fatigue resistance2. So polyamide was introduced into dentistry to be used as a denture base material in order to solve these problems. Polyamide denture base materials have some superior properties than PMMA as; High impact \& flexural strength, excellent esthetics and less release of residual monomers4. Although being an advantage from the point of patient satisfaction, flexural property considered to be a contraindication for a denture base material.

The invistigators' trial is done in order to improve rigidity of a polyamide material as well as to improve oral health related quality of life in comparison to heat cured polymethyl methacrylate.


Eligibility Criteria:
Inclusion Criteria:

- i. Male or female patient with age range (45-55) and in good medical condition ii. All patients have skeletal Angle's class I maxillo-mandibular relationship and have sufficient inter-arch distance.

iii. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles.

iv. Free from any tempro-mandibular joint disorder. v. The patients have good oral hygiene.

Exclusion Criteria:

- i. Patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included.

ii. Patient with xerostomia or excessive salivation. iii. Patient with abnormal tongue behavior and/or size. iv. No intraoral soft and hard tissue pathosis