cyrilzakka/clinical-trials huggingface dataset:
Integrated Case Management for Burns Care in Pakistan

To test whether a culturally adapted multicomponent intervention for improving burns care and patient/family rehabilitation is effective in improving survival among burn victims in Pakistan and is cost-effective. The comparator will be usual care plus brief written self-help advice (enhanced usual care). The study is designed as a multicentre, pragmatic, parallel group, individually randomised trial. Participants in the intervention arm will receive 8 sessions delivered by the case managers (6 low-intensity sessions lasting 30-60 minutes in the hospital/community and 2 follow-up sessions lasting 30 minutes in the community). Assessments will be conducted at baseline, at 3 months, 6 months and at 12-months post-intervention.

The Burns trial will be conducted in six cities of Pakistan; Karachi, Hyderabad, Lahore, Rawalpindi, Peshawar and Quetta to compare integrated intervention with enhanced usual care. Participants will be randomized either to the intervention or enhanced usual care. The intervention consists of multiple culturally adapted components such as psychological bundle, emergency care, surgical and rehab bundle to improve care within burn units, transitional care, and patient and family rehabilitation (known as 'Integrated case management for improved psychosocial and physical rehabilitation of burn survivors and their families'). The comparator will be usual care (emergency, surgical and rehab care ) plus brief written self-help booklets will be given(enhanced usual care).

The intervention will be carried out by case managers (trained allied health professionals such as nurses, physiotherapists, psychologists etc) and will be started during hospital stay to enhance physical health outcomes by educating patients about self-care/ medications and adherence to treatment resources provided to the case managers and upon discharge to the participants and their carers.

Participants in the intervention arm will receive 8 sessions delivered by the case managers (6 low-intensity sessions lasting 30-60 minutes in the hospital/community and 2 follow-up sessions lasting 30 minutes in the community). Assessments will be conducted at baseline, at 3 months, 6 months and at 12-months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and over
* Accidental burn injury and meet the criteria for admission to burn centres
* Clinician judgment for participation readiness
* Ability to provide informed consent

Exclusion Criteria:

No intentional burn injuries

• Lacking capacity to provide informed consent
Assessment of the Uro-C Cystoscope for Use in Diagnostic Cystoscopy Procedures

This is a prospective, multicenter, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of a new cystoscope for direct visualization of the urethra and bladder.

A new cystoscope has been designed for female diagnostic cystoscopy, with a focus on promoting patient comfort, tolerability and safety while improving office efficiency. The cystoscope, named the Uro-C, is light-weight, ergonomic, handheld, battery-operated portable system that integrates a disposable cannula with a reusable handle that contains video electronics, is wireless capable, and has a liquid crystal display (LCD) monitor. Cystoscopy with the new system is performed in a standard manner to cystoscopy with currently available endoscopes, so risks are no different than when currently available endoscopes are used.

This is a prospective, multi-center, single-arm, open-label clinical usability study in subjects who are candidates for office diagnostic cystoscopy. The primary objective of this initial device assessment is to evaluate the performance of the cystoscope for direct visualization of the urethra and bladder.

Eligibility Criteria:
Inclusion Criteria:

1. Otherwise healthy adult (18 years of age or older) women presenting for cystoscopy for diagnostic purposes; and
2. Ambulatory and able to undergo routine cystoscopy in the lithotomy position.

Exclusion Criteria:

1. History of prior bladder/urethral surgery other than TURBT; or
2. History of interstitial cystitis; or
3. Presence of urinary tract infection (UTI); or
4. Gross hematuria; or
5. History of pelvic radiation therapy; or
6. Procidentia; or
7. Unable to read, understand, and/or provide a ranking of pain level during the procedure; or
8. Unable or unwilling to provide consent to participation in the study.
Irbesartan in Type 2 Diabetes

The aim of this multicenter, doubleblind, randomized study was to investigate the renoprotective effect of irbesartan treatment in patients with type 2 diabetes and microalbuminuria (a precursor of diabetic kidney disease). 590 patients were randomized to a median 24 months of treatment with 300 mg irbesartan once daily, 150 mg irbesartan once daily or placebo. Time to development of overt nephropathy, defined by persistent proteinuria, was the primary outcome measure.


Eligibility Criteria:
Inclusion Criteria:

Type 2 diabetes. Hypertension. Persistent microalbuminuria. Serum creatinine concentration of no more than 1.5 mg per deciliter (133 µmol per liter) for men and no more than 1.1 mg per deciliter (97 µmol per liter) for women. -

Exclusion Criteria:

Nondiabetic kidney disease. Cancer. Life-threatening disease with death expected to occur within two years. Indication for angiotensin-converting- enzyme (ACE) inhibitors or angiotensin-II-receptor antagonists. -
Dynamic Proteomics and Integrated Rates of Muscle Protein Synthesis During an Acute Period of Loading and Unloading

Skeletal muscle plays several different roles in the promotion and maintenance of health and well-being. The loss of muscle mass that occurs with aging, chronic muscle wasting diseases, and physical inactivity puts people at an increased risk of frailty and becoming insulin resistant, and therefore imposes a significant burden on health care spending. Resistance exercise participation has proven particularly effective for increasing muscle mass and strength. This effectiveness can be used by health care practitioners in a rehabilitation setting to promote the recovery of individuals who have undergone involuntary periods of muscular unloading (i.e. limb immobilization caused by a sports injury or reconstructive surgery). However, there is large variability in the amount of muscle mass and strength that people gain following participation in resistance exercise. Some individuals fail to increase the size of their muscle (low responders) whereas others show vary large increases in muscle size (high responders) in response to the same resistance training program. People also show differences in the amount of muscle tissue they lose when they have a limb immobilized. To circumvent variability across individuals, the investigators utilized a within-person paired Hypertrophy and Atrophy ('HYPAT') strategy that reduced response heterogeneity by \~40% (Available at: https://ssrn.com/abstract=3445673). Specifically, one leg performed resistance training for 10 weeks to induce hypertrophy, whereas the other leg underwent single-leg immobilization for 2 weeks to induce atrophy. The primary goal of the study will be to gain insight into the molecular responses to an acute period of single-leg immobilization and resistance exercise (8 days). The investigators will use an integrated systems biology approach to monitor the individual rates of over one hundred different muscle proteins.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males, between the ages of 18 and 30 y
* Body Mass Index between 18.5 and 30.0 kg/m2
* Able and willing to provide informed consent

Exclusion Criteria:

* A history of neuromuscular disorders or muscle/bone wasting diseases.
* Any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin-dependent or insulin-independent diabetes, or the presence of any other metabolic disease - all of which will be determined via a medical history screening questionnaire.
* The use of any medications known to affect protein metabolism (glucocorticoids, non-steroidal anti-inflammatory medication, or prescription strength acne medication, etc.).
* A (family) history of thrombosis.
* The use of anticoagulant medications.
* Consumption of tobacco-containing products.
* Excessive alcohol consumption (\>21 units/wk).
* History of bleeding diathesis, platelet or coagulation disorders, or anti-platelet/anticoagulation therapy.
* Exercise participation \>2 days/wk (structured resistance and/or aerobic-type exercise)
Preventing Retaliatory Gun Violence in Violently Injured Adults

The purpose of this research study is to find out if a hospital-based violence intervention (Bridging the Gap) is effective for reducing violence. The researchers think that adults who receive Bridging the Gap will see greater improvements than those who do not receive the intervention. This study will allow them to learn more about the intervention's effectiveness. The study will also help them understand if the violence intervention affects other behaviors, such as firearm use, drug use, aggression, risky behaviors, and rates of violent re-injury.

Approximately 616 patients will enroll in this study. Participants will be asked to complete sessions about behavior, personality, and experiences. Participants will be randomized into a study group (either Bridging the Gap or Treatment as Usual) by drawing a number. If patients agree to the study but do not like the group they are assigned to, they can request to switch groups. Participants assigned to the Treatment as Usual intervention will receive a brief violence awareness brochure during your hospital stay. Participants assigned to the Bridging the Gap intervention will receive an in-hospital intervention and, once released from the hospital, will receive 6-months of community case management services. The study team thinks that adults who receive the Bridging the Gap intervention will see greater improvements than adults who do not receive the intervention. This study will allow them to learn more about the intervention's effectiveness.

During these study sessions participants will complete questionnaires about exposure to traumatic events, symptoms of trauma, history of suicide, aggression and violence, antisocial personality traits, illegal behaviors, substance use, and mental health. Participants will complete several tasks which measure cognitive ability, such as problem-solving, attention/concentration, and decision-making. They will also complete a clinical interview that covers antisocial personality traits and behaviors, including history of aggressive behavior and substance use. These interviews will be video recorded. These recordings will be used to help score the interviews and for training purposes. Information will also be collected from participant's medical records, including demographic information, history and reason for past hospitalizations, mental health history, and substance use reports, as well as a criminal background check.

The surveys take about 2 hours to complete. Participants will complete these questionnaires again 6 and 12 months later. Participation in this study will last up to 12 months.

Eligibility Criteria:
Inclusion Criteria:

* They receive treatment in the hospital for a violence-related injury (e.g., gunshot wound)
* They are 18 years or older
* They are English speaking
* They are eligible for BTG services (which includes living within the BTG catchment area for the hospital; Richmond City and neighboring counties)

Exclusion Criteria:

* Non-English speaking
* Age \<18
* Prisoners
Evaluation of Xueshuantong in Patients With AcutE IschemiC STroke

The aim is to assess the effects and harms of Xueshuantong lyophilized powder versus placebo in patients with acute ischemic stroke when initiated within 72 hours of symptom onset.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of acute ischemic stroke.
2. Patients that can be treated with study drug within 72 hours of symptoms onset defined by the "last see normal" principle.
3. 4 ≤ NIHSS score ≤ 16 (total score of upper and lower limbs on motor deficits ≥ 2) at the randomization time.
4. Female or male aged ≥ 18 years and ≤ 80 years.
5. Provision of signed informed consent prior to any study-specific procedure.

Exclusion Criteria:

1. Patients who have received intravenous/intra-arterial thrombolysis or mechanical thrombectomy prior to randomization.
2. Secondary stroke caused by tumor, traumatic brain Injury, hematological disease or other diseases with the explicit diagnosis.
3. mRS grade ≥ 2 pre-morbid historical assessment.
4. Other conditions that lead to motor dysfunction (e.g. claudication, severe osteoarthrosis, rheumatoid arthritis, gouty arthritis or other diseases).
5. Known severe impairment of liver function or renal function.
6. Known hypersensitivity to study drugs.
7. Known severe comorbidity with life expectancy \< 3 months.
8. Known massive cerebral infarction combined with disturbance of consciousness (1a ≥ 2 in NIHSS), dementia, mental impairment, or unsuitable for participation, in the opinion of the investigator.
9. Pregnancy or breastfeeding.
10. Participation in another clinical study with an investigational product at any time during the 3 months prior to randomization (regardless of when treatment with the investigational product was discontinued).
Treatment of the Cholesterol Defect in Smith-Lemli-Opitz Syndrome

The purpose of this study is to determine whether supplementation with an oil-based cholesterol suspension will correct the biochemical abnormalities in cholesterol and its precursors in individuals with the Smith-Lemli-Opitz syndrome.

This study involves treating individuals with the Smith-Lemli-Opitz syndrome, a rare inborn error of cholesterol metabolism, with supplemental cholesterol to determine it effects on biochemical sterol metabolites, growth, neuropsychological development, ophthalmologic and auditory function, ERG (electroretinogram) parameters, and CNS metabolites as determined by brain MRS-imaging. Safety of the supplemental cholesterol suspension is monitored by tests of hematologic, renal, and liver function at periodic intervals. There is also a substudy that is investigating potential genotype-phenotype correlations, as well as another that studies biochemical parameters of light sensitivity in cultured skin fibroblasts from affected patients.

Eligibility Criteria:
Inclusion Criteria:

* Biochemical confirmation of sterol defect associated with Smith-Lemli-Opitz syndrome

Exclusion Criteria:

* Inability to tolerate crystalline cholesterol
* Inability to travel to Boston 3-4 times/year based on age
EN3835 for the Treatment of Edematous Fibrosclerotic Panniculopathy (Commonly Known as Cellulite)

The study will evaluate the safety, effectiveness, and immunogenicity of EN3835 in the treatment of adult women with Edematous Fibrosclerotic Panniculopathy (Commonly known as Cellulite).


Eligibility Criteria:
Inclusion Criteria:

* Be a female ≥18 years of age
* At Screening visit, have at least 1 quadrant with:

  * a score of 3 or 4 (moderate or severe) as reported by the subject (PR- PCSS), and
  * a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and
  * a Hexsel CSS score no greater than 13
* At Day 1 visit, have an assigned quadrant with:

  * a score of 3 or 4 (moderate or severe) as reported by the subject (PR-PCSS), and
  * a score of 3 or 4 (moderate or severe) as reported by the Investigator (CR-PCSS), and
  * a Hexsel CSS score no greater than 13
* Be willing to apply sunscreen to the selected treatment quadrant before each exposure to the sun while participating in the study (ie, screening through end of study).
* Be judged to be in good health, based upon the results of a medical history, physical examination, and laboratory profile at screening
* Have a negative urine pregnancy test at screening and be using an effective contraception method (eg, abstinence, intrauterine device \[IUD\], hormonal \[estrogen/progestin\] contraceptives, or double barrier method) for at least 1 menstrual cycle prior to study enrollment and for the duration of the study; or be menopausal defined as 12 months of amenorrhea in the absence of other biological or physiological causes, as determined by the investigator; or post-menopausal for at least 1 year; or be surgically sterile.
* Be willing and able to cooperate with the requirements of the study
* Voluntarily sign and date an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).
* Be able to read, complete and understand the Patient Reported Outcomes rating instruments in English

Exclusion Criteria:

* Has any of the following conditions:

  * Thyroid disease, unless controlled with medication for ≥6 months
  * Uncontrolled diabetes mellitus, as determined by the Investigator
  * Uncontrolled hypertension, as determined by the Investigator
  * Vascular disorder (eg, phlebitis or varicose veins) in area to be treated
  * Cushing's disease and/or use of systemic corticosteroids at a total daily dose greater than 5 mg prednisone (or equivalent)
  * History of lower extremity thrombosis or post-thrombosis syndrome
  * Documented autoimmune disorder such as lupus erythematosus, rheumatoid arthritis
  * Inflammation or active infection in area to be treated
  * Active cutaneous alteration in area to be treated including rash, eczema, psoriasis or skin cancer
  * History of keloidal scarring or abnormal wound healing
  * Coagulation disorder
  * Taking a medication for chronic anticoagulation (except for ≤150 mg aspirin daily)
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.


Eligibility Criteria:
Inclusion Criteria:

* Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
* Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
* Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
* Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
* ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
* ECOG performance status 0-1.
* Adequate bone marrow, kidney and liver function.

Exclusion Criteria:

* Prior treatment with PARP inhibitor.
* Patients with HER2 positive disease.
* More than 2 prior lines of chemotherapy for metastatic breast cancer.
* Untreated and/or uncontrolled brain metastases.
* Prior malignancy unless curatively treated and disease-free for \> 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.
* Known HIV (Human Immunodeficiency Virus) infection.
* Pregnant or breast-feeding women.
Basal Ganglia Local Field Potentials in Gait and Speech

Electrid activity of the basal ganglia will be recorded with an implantable deep brain stimulation device (supplied by Medtronic Inc).

Study hypothesis is that these activities differ according to what the patient does, i.e. are different during gait and speech.


Eligibility Criteria:
Inclusion Criteria:

* good levodopa response

Exclusion Criteria:

* dementia
Assessment of Intracerebral Hematoma

The study will assess acute intracerebral hematoma expansion within the first 48 hours from the onset using transcranial duplex sonography in patients who have acute intracerebral hematoma , and will also assess the correlation between the transcranial duplex sonography measurements and the clinical outcome of these patients .


Eligibility Criteria:
Inclusion Criteria:

1. first ever non traumatic supratentorial primary intracerebral haemorrhage on non contrast CT brain
2. admitted within 24 hours of symptom onset

Exclusion Criteria:

1. blood diseases, decompansated hepatic or renal impairment, or encephalopathy caused by electrolyte disturbance
2. on anticoagulant treatment
3. if devolped major complications during hospitalization ( e.g sever chest infection, hypoxia, or deep venous thrombosis )
4. comorbid neurological or psychiatric disorders
Median Nerve Excursion During Neurodynamic Mobilization

This study will compare changes in longitudinal median nerve excursion when neck flexion and ipsilateral rotation are added to the standard Median neurodynamic test1 (MNT1) position in patients with carpal tunnel syndrome (CTS) and normal controls.

Median nerve excursion will be assessed by ultrasonography during three positions: standard MNT1, neck flexion with MNT1, and ipsilateral rotation combined with MNT1. Both arms will be tested.

Arm will be held in abduction to 90° - 110° and external rotation to 90°, forearm supination, elbow extension and wrist and fingers extension using a custom made splint.

The standard MNT1 includes neck contralateral side flexion. Then, the researcher will move the neck passively into rotation and flexion. Passive range limit will be determined prior to testing using a goniometer and passive end feel. Movement order will be randomized using an excel random function.

Every position will be tested three times. A single researcher will do all movements passively. Nerve excursion will be measured in real time by the same ultrasonographer who is blinded to patients grouping.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of mild to moderate CTS.
* Must be able to tolerate the entire standard MNT1 position.

Exclusion Criteria:

* Severe CTS.
* Symptoms referred to the neck.
* Limited neck flexion, rotation, and side bending ranges (\>10%).
* History of upper quadrant trauma, dysfunction or surgery.
* History of peripheral neuropathy or cervical radiculopathy.
* History of systemic disease associated with neuropathies such as diabetes mellitus, connective tissue diseases, thyroid disease, or obesity.