cyrilzakka/clinical-trials huggingface dataset:
Risk Reduction Intervention for Vulnerable Young Adult Males

The primary aim of this study is to test a brief 4-session risk reduction intervention, based on Motivational Enhancement Therapy (MET) to reduce the co-occurrence of club drug use and sexual risk taking behaviors among non-treatment seeking young men who have sex with men (YMSM) in NYC.

This study is a randomized clinical trial. A sample of 300 non-treatment seeking YMSM (ages 18-24) who report risky sex and club drug use in the past 90 days are being enrolled using active and passive community-based recruitment strategies in NYC. After baseline assessment, participants are being randomly assigned to one of two study arms: a Brief Risk Reduction Intervention Condition - a four session MET intervention piloted for feasibility and acceptability among YMSM, designed to increase readiness to change club drug use and unprotected sex; or an Education Comparison Condition - four sessions of facilitated education regarding the effects of club drugs and unprotected sex. Participants undergo follow-up assessments 3, 6, 9, and 12 months after baseline.

Eligibility Criteria:
Inclusion Criteria:

* At least 5 days of drug use (cocaine, ketamine, ecstasy, methamphetamine, or GHB) in the past 90 days;
* At least 1 instance of unprotected anal sex in the past 90 days;
* Biological male;
* HIV-negative;
* Residential stability;
* Ability to communicate in written English.

Exclusion Criteria:

* Unstable, serious psychiatric symptoms;
* Currently suicidal/homicidal;
* Evidence of gross cognitive impairment;
* Reports current enrollment in a drug or HIV related intervention or research study.
Testing the Effects of a Text Message Caregiver Support Intervention for Latinos

The goal of this randomized clinical trial it to test the efficacy of CuidaTEXT, the first Alzheimer's disease and Related Dementias (ADRD) caregiver support intervention to capitalize on text messaging, among Latinos.

Researchers will compare those who receive the CuidaTEXT intervention to those who do not receive the intervention to see if CuidaTEXT effects Latino caregiver stressors and their negative consequences .

Participants will receive a variety of text messages, from automatic to keyword-drive, regarding ADRD education, social support, self-care, ADRD care management, and behavioral symptoms. Participants will also complete measures regarding depressive symptoms, coping, behavioral symptoms, and preparedness for caregiving.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Spanish and English-speaking people who identify as Latino
* Reports providing hands-on care for a relative who has been given a clinical or research ADRD diagnosis and has an Eight-item Informant Interview to Differentiate Aging and Dementia (AD-8) screening score ≥2, indicating cognitive impairment
* Has a score of 7 or higher on the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10)
* Self-reports being able to read and write
* Owns a cell phone with a flat fee, and uses it at least weekly for texting.

Exclusion Criteria:

* Participation in another wellbeing-related clinical trial
* Cohabitation with another participant in the CuidaTEXT R01 Study
* Participants who provide care for a person with ADRD already cared for by another participant in the CuidaTEXT R01 study
* Participant plans to move to another country within seven months
Novel Energy Metabolic Signaling Molecule With Therapeutic Potential

Altogether a 25-day study. First 4 days non-blinded with water before 0-control blood samples (Day0). Thereafter blinded for 21 days (3 weeks). Study group was apparently healthy 50-60 -year-old males and females (N=27).

Blinded 21-day period was divided into two sub-periods (7 days and 14 days) and it included 3 measurement days. All measurements were on the same day of each week to facilitate maximal comparability (Day0, Day7 and Day21). Additionally on Day0 and Day7 there were acute measurements 45 minutes after morning "non-acute" resting and fasting blood samples. (In a "non-acute" measurement last dose of Panavital or placebo was taken 12 hours before the "non-acute" blood sample collected next morning .)

First week started with Day0 baseline measurements and immediately thereafter a strenuous VO2max test with 2 recovery days thereafter. After full recovery a 4-day blinded Panavital regimen. Last "non-acute" dose on Day6 was taken 12 hours before Day7 morning blood sample. At Day7 an acute 45 min placebo comparison was conducted.

Thereafter a 14-day follow-up period with halved Panavital dose or Placebo. Altogether 5 arterial blood samples were withdrawn. Three fasting and resting "non-acute" samples were taken in the morning before any treatments at Day0, Day7 and Day21. Two acute samples were collected after the VO2max (Day1) and after acute Panavital or placebo doses (Day7).

Additionally 5 fingertip blood samples for glucose (and lactate) were taken at the same time as arterial samples (Day0 and Day7) and one fingertip sample was taken immediately at the end of VO2max.

Eligibility Criteria:
Inclusion Criteria:

* healthy 50-60 year-old females and males

Exclusion Criteria:

* history of cardiovascular diseases, overweight (BMI \>32)
Phase 3 Study of Futuximab/Modotuximab in Combination With Trifluridine/Tipiracil Versus Trifluridine/Tipiracil Single Agent in Participants With Previously Treated Metastatic Colorectal Cancer

This is a randomized phase III study with a safety lead-in part in patients with KRAS/ NRAS and BRAF Wild Type metastatic colorectal cancer who have previously received treatment with oxaliplatin, irinotecan, fluoropyrimidines, anti-VEGF agents and anti-EGFR antibodies. The main objective of the safety lead-in part is to assess safety and tolerability of futuximab/modotuximab in combination with trifluridine/tipiracil. The primary objective of the phase III part is to compare Overall Survival of futuximab/modotuximab in combination with trifluridine/tipiracil vs trifluridine/tipiracil monotherapy in patients with tumours that are KRAS/NRAS and BRAF wild-type (WT).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of metastatic colorectal cancer (mCRC), not amenable to surgical intervention due to either medical contraindications or non-resectability of the tumour without RAS (KRAS and NRAS) and BRAF V600E mutations based on Circulating tumour DNA (ctDNA) screening blood test analysis
* Participants with measurable or non-measurable lesion
* Participants must have received at least 2 prior regimens of standard chemotherapy for mCRC and had demonstrated progressive disease or intolerance to their last regimen
* Participants should have received previous treatment with commercially available anti-EGFR mAbs for ≥ 4 months
* Estimated life expectancy ≥ 12 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Adequate haematological, renal and hepatic function

Exclusion Criteria:

* Pregnancy, possibility of becoming pregnant during the study, breastfeeding woman
* Patients currently receiving or having received anticancer therapies within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part).
* Major surgery within 4 weeks prior to the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part) or participants who have not recovered from side effects of the surgery
* Participants with serious/active/uncontrolled infection
* Known clinically significant cardiovascular disease or condition
* Significant gastrointestinal abnormality
* Skin rash of Grade \> 1 from prior anti-EGFR at the time of inclusion (Safety Lead-in part) or randomization (Phase 3 part), or any other skin toxicity precluding participation in the study according to investigator's discretion.
* Treatment with systemic immunosuppressive therapy within 4 weeks prior to inclusion (Safety Lead-in part) or randomization (Phase 3 part)
* Prior radiotherapy if completed less than 4 weeks before the inclusion visit (Safety Lead-in part) or randomization visit (Phase 3 part)
* Patients with other malignancies
Valvuloplasty Scoring Balloon Catheter First-in-Man Study

The Valvuloplasty Scoring Balloon First-in-Man study is a prospective, single arm, two phase, observational registry to demonstrate the safety and efficacy of the Valvuloplasty Scoring Balloon Catheter for the treatment of critical aortic valve stenosis.

Phase 1 will enroll patient who are scheduled to undergo open surgical aortic valve replacement and will have the Valvuloplasty Scoring Balloon delivered to their stenotic aortic valve through a standard aortotomy and deployed immediately prior to valve replacement.

Phase 2 will enroll patients with aortic valve stenosis who are deemed to not be suitable candidates for elective surgical aortic valve replacement and in whom the investigational Valvuloplasty Scoring Balloon will be used as a stand-alone Valvuloplasty procedure or "bridge" to trans-catheter aortic valve implantation (TAVI) or surgery.

Eligibility Criteria:
Inclusion Criteria:

* Native, degenerative-calcific, tricuspid, aortic valve stenosis with echocardiographic derived criteria: mean gradient of \>40 mm Hg or Doppler peak systolic velocity greater than 4.0 m/s or an initial aortic valve area \< 0.8 cm2.
* Symptomatic aortic valve disease as demonstrated by CCS Functional Class II or greater
* Aortic valve annulus of greater than or equal to 18 mm and less than or equal to 28 mm measured on pre-procedure TTE.
* Phase 1 patients must be scheduled for a surgical aortic valve replacement.
* Phase 2 patients must not be suitable candidates for elective surgical aortic valve replacement.

Exclusion Criteria:

* Recent myocardial infarction (\<30days)
* Unicuspid or bicuspid aortic valve or non-calcific aortic valve stenosis
* Any sepsis, including active endocarditis
* Concomitant 2+ or greater aortic valve valve regurgitation
* LVEF \< 20%
* CVA or TIA within the previous 6 months
* Previous aortic valve replacement (bioprosthetic or mechanical)
Comparison Between a Two Person Insertion With Lateral Rotation Technique of LMA and the Classic Technique

The laryngeal Mask Airway was developed by Brain in 1981 and was available for clinical use in the United States by 1992 and has become very popular in routine medicine practice during 10 past years . LMA would serve as a choice to be used in the emergency situations even by the inexperienced users . Nowadays due to the increasing number of outpatient anesthesia and use of short-acting anesthetics almost without the use of any muscle relaxants requires an appropriate way for safe LMA insertion. As LMA insertion is generally performed blindly, clinicians are always in search of how to place and maintain the LMA in appropriate position.

The standard method of insertion described by Dr. Brain is relatively easy, but sometimes it is impossible to insert the LMA with the standard method. However ease and time of airway management may be of special importance in emergent situations. Since its inception the LMA has undergone various modifications in type and material, which have made other methods of insertion possible, quicker and easier than the standard method. Intraoral manipulation can put the operator at risk of finger trauma and infection. However it is not possible to avoid intraoral manipulation when the standard technique or the classic LMA is used.

Therefore, many studies were seeking to find new methods to improve this technique. Hwang et al. first described The 90° rotation technique in adults that involves the following steps: the entire cuff of the LMA is inserted inside the mouth, rotated counter-clockwise through 90° and advanced until the resistance of the hypopharynx is felt . The use of this method is known to increase the success rate of insertion and decrease the incidence of blood staining of the LMA and sore throat compared to standard technique . Ghai et al. showed that rotational technique may be considered as the first technique of choice for classical laryngeal mask airway insertion in children . Lopez-Gil and colleagues reported a decrease in complications with the increase in the skill of the anaesthetist . PARVIZ et al. described a two person technique which performed by the technician who performs mouth opening and jaw thrust and the anesthesiologist who inserts the laryngeal mask. They considered it as a safe and effective method to establish a secure airway in anesthetized patients.. other studies have shown that LMA insertion with partially inflated cuff is easier than deflated cuff .

Current study will combine two methods of LMA insertion including two-persons and lateral rotational techniques and compare them with the standard insertion method regarding the success rate and incidence of complications.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status grade I-II,
* Age between 20-55 years old
* undergoing minor surgeries under general anaesthesia using LMA

Exclusion Criteria:

* patients at Risk of aspiration,
* Mouth opening ˂ 2.5 cm,
* BMI ≥ 35 kg/m2,
* dental problems,
* recent history of upper airway infection,
* gastro-oesophageal reflux disease and
* limited extension of the neck.
Effects of Routine Physical Therapy With and Without Proprioceptive Neuromuscular Facilitation on Balance, Gait and Function in Patients With Parkinson's Disease

Objective of this study is to compare the effectiveness of routine physical therapy with and without Proprioceptive Neuromuscular Facilitation on Balance, gait and function in patients with Parkinson's disease.

Alternate hypothesis:

There will be a difference in the effects of routine physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait and function in patients with Parkinson's disease.

Null hypothesis:

There will be no difference in the effects of routine physical therapy with and without proprioceptive neuromuscular facilitation on balance, gait and function in patients with Parkinson's disease.

It will be a prospectively registered, parallel designed, single blinded randomized controlled trial with concealed allocation, conducted in University of Lahore Teaching Hospital and Sir Ganga Raam hospital, Lahore, Pakistan. Patients who met eligibility criteria will be informed about the aim of study.consent form will be signed by all eligible participants. Eligibility of participants will be confirmed by the physiotherapist of research team before randomization. After baseline assessment, eligible patients will be randomly allocated(in a 1:! ratio) in two groups( group A and group B). Fish bowl method of randomization will be used and will be done by one of the research team members who will not involve in patient recruitment or assessment or data analysis.

Randomization assignments will be kept in opaque, sealed envelopes for concealment of group allocation and will be unsealed by researcher after baseline testing. Researchers who assess outcomes or will do data analyses will be masked to group allocation.The calculated sample size is 32 (16 in each group), after adding 20% dropout the sample size will be 32+6=38, 19 patients in each group.(statistical power 80% and alpha level of 5%).

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients of age between 60 and 85 years, diagnosed with Parkinson's disease by a neurologist.
* Patients with Hoehn and Yahr stages 1-3.
* Patients with a stable drug program and acclimated to their current medication use for at least 2 weeks.

Exclusion Criteria:

* Cognitive deficits (scores of \<26 on the Mini-Mental State Examination).
* Moderate or severe depression (scores of \>17 on the Beck Depression Inventory).
* Patients with neurological diseases, arthrosis, or total hip joint replacement.
the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC83518 Tablets

Multiple Dose Safety, Tolerability, PK ，PD and Food Effect Study of HEC83518 in Healthy Subjects


Eligibility Criteria:
Inclusion Criteria:

1. Subjects who are willing and are able to provide a written informed consent to participate in the study.
2. Without Plan for pregnancy or pregnant within 3 months after enrollment throughout the trial.
3. Subjects aged between 18 and 45 (both inclusive) years old.
4. Healthy volunteers have a body weight ≥50 kg (for male) or ≥ 45kg (for female) and body mass index ≥18 and ≤28 kg/m2 at screening.
5. Subjects, who are healthy, as having no clinically significant abnormalities in vital signs, physical examination, clinical laboratory test results, Chest X-ray and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

1. Subjects with a heart rate ≥100 beats per minute or ≤ 60 beats per minute at screening or baseline.
2. Subjects with a positive serology for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies and/or TP antibodies at screening.
3. Subjects with history of digestive system,urinary system, liver,central nervous system, blood system, endocrine system,respiratory system,immune system,cardiovascular system,and/or malignant tumor or others medical conditions (such as history of mental illness, etc.) that are not suitable for clinical trial participation;Subjects with history of stroke, epilepsy, bipolar disorder/mania, high intraocular pressure, or acute angular-closure glaucoma.
4. Subjects with history of sleep-related illness.
5. Subjects with history of severe involuntary hypoglycemia
6. Known allergic reactions or hypersensitivity to any excipient of the drug formulation(s) ,or anaphylaxis physique.
7. Use of any prescription or non-prescription medications within 14 days prior to initial dosing,or Use of any medications known to inhibit or induce cytochrome P enzyme drug metabolism within 28 days prior to initial dosing.
8. Consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing.
9. Positive results from urine drug screen test.
10. History of alcoholism or drink regularly within 3 months prior to the study(defined as Alcohol consumption of \> 21 units/week), or positive results from alcohol breath test.
11. Regular smoking of more than 10 cigarettes per day within 3 months before administration of study drug.
12. Donate blood or lose blood 400 mL or more within 1 month prior to initial dosing.
13. Subjects who plan to receive or have had organ transplants.
14. Females who are lactating/breastfeeding, or positive result from pregnancy test for women of child-bearing potential. 15 Subjects who participated in another clinical trial within 3 months prior to initial dosing.

16.Any other condition with in the opinion of the investigator would render the patient unsuitable for inclusion in the study.
Exploratory Study of Predictive Markers of the Therapeutic Response in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy Treated With Intravenous Immunoglobulin

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) is an acquired neuropathy characterized by an inflammatory multifocal segmental demyelination. Due to the clinical heterogeneity of this condition and the lack of specific marker that can reliably identify all patients, the diagnosis of CIDP remains difficult. Similarly, there are no clear factors predicting the evolution or the prognosis of the disease. Current treatments are the intravenous immunoglobulin (IVIg), corticoids and plasma exchange; IVIg therapy being the most commonly used. Responses of the patients to the treatments are variable. Thus, it is necessary to identify predictive markers of the therapeutic response of CIDP patients treated by IVIg.

Several potential biomarkers have been proposed recently, but none of them has yet been validated as a predictive criterion for therapeutic response. It is therefore necessary to continue to investigate several biological parameters to identify a reliable biological marker.

In electromyography, the Motor Unit Number Index (MUNIX) technique allows measuring the axonal loss by a precise count of functional motor units. This method, more sensitive than the measure of the Compound Muscle Action Potential (CMAP), is rarely used in CIDP. MUNIX might be a good tool to better characterize the patients and to follow the course of CIDP. It also might be a new sensitive and reliable marker predictive of the therapeutic response.

Magnetic resonance Imaging (MRI) is increasingly used for the assessment of neuromuscular diseases. A recent study on CIDP patients reported a significant decrease of the muscle Magnetisation Transfer Ratio (MTR) compared to healthy subjects, correlated to clinical parameters. The use of advances MRI techniques could allow characterizing the structure and composition of muscle and nerve tissues of CIDP patients. It could also be a mean for identifying potential new markers, largely unexplored until now, that might be sensitive to disease course and/or IVIg response.

The objective of this study is to identify predictive markers of the treatment response of CIDP patients receiving IVIg.

This is a prospective observational exploratory study of a cohort of 30 CIDP patients treated with IVIg and followed-up during one year.


Eligibility Criteria:
Inclusion Criteria:

* Suffering from CIDP
* Fulfilling the EFNS/PNS (European Federation of Neurological Societies / Peripheral nerve Society) 2010 revised criteria
* Treated with IVIg or needed to be treated with IVIg

Exclusion Criteria:

* Patients with a known hypersensitivity to the normal human Ig or one of the constituents of the preparation
* Patients with a known IgA deficiency or with anti-IgA circulating antibodies
* Patients with a change in their immunosuppressive or immunomodulatory treatment in the last 6 months
* Patients with a contraindication for MRI explorations
Stem Cells Predicting Orthopedic Outcomes

This is a pilot study to provide preliminary data of the association between bone mineral denity adjacent to acetabular implants, as measured by quanitative computed tomography (QCT), at least 2 years post Total Hip Arthoplasty (THA) surgery with Mesechymal stem cell assays, obtained at time of surgery, and to begin to evaluate if stem cells can predict orthopaedic surgical outcomes.

Subjects who have undergone a THA and who previously consented to "Stem Cell Quality Assays: Correlation with Aging/Health" study which used excess bone marrow and blood samples to complete stem cell assay labs will be invited back at least 2 years post THA to complete bilateral hip x-rays, if not already completed as part of routine medical follow up plus a QCT bone density testing and to complete a questionnaire regarding smoking, alcohol and exercise history along with recording BMIs.

This ability to identify older individuals with compromised stem cell function could offer opportunities to develop and test new preventative and therapeutic strategies to improve outcomes.

Eligibility Criteria:
Inclusion Criteria:

* subjects who previously had a total hip arthroplasty and had stem cell assays completed on excess bone marrow

Exclusion Criteria:

* Subjects who do not wish to participate.