cyrilzakka/clinical-trials huggingface dataset:
Endothelin-1 and Methabolites Concentrations in Mycrodialysis and Cerebrospinal Fluid in Subarachnoid Hemorrhage Patients

Endothelin-1 (ET-1) seems to be involved in the pathogenesis of cerebral vasospasm after subarachnoid hemorrhage. However measurements of cerebrospinal fluid concentrations (CSF) of ET-1 are not sensitive enough to predict the development of vasospasm representing the average value throughout the entire cerebral circulation. Cerebral microdialysis (MD) is a technique able to detect molecule concentrations in a small perivascular area. The investigators performed a prospective observational clinical study to test the hypothesis that MD ET-1 concentrations should be a sensitive predictor for vasospasm.

Patients with subarachnoid hemorrhage at high risk for vasospasm according to Fisher scale admitted to the ICU were consecutively studied. All patients received surgery within 48 hours from the bleeding; MD probe was placed in the area at risk for vasospasm after surgery and samples were hourly collected and analysed to measure lactate, piruvate and glutamate levels; ET-1 levels in CSF and MD fluids were measured from admission until day 7. At admission and after 7 days two angiographies were performed to detect the degree and extent of vasospasm, Transcranial Doppler and neurological evaluation were daily performed. Patients were then classified according to the presence of vasospasm in 3 groups: absence of vasospasm (NV), presence of vasospasm (CV), acute neurological deterioration (AND).


Eligibility Criteria:
Inclusion Criteria:

* diagnosys of subarachnoid hemorrhage
* angiographic proof of aneurysm
* admission within 24 hours from the subarachnoid hemorrhage
* presence of an intraventricular catheter and a microdialysis catheter placed either after admission or at the time of the surgery

Exclusion Criteria:

* moribund
* GCS=3
* denied consent
AUSTrian Randomized Interventional Study on Dialysis Accesses

Patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. The KDOQI Guidelines For Vascular Access follows a "fistula first" approach for every patient, whenever possible. Thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (TCC). These recommendations are based on retrospective and register studies. There have been no prospective studies in this subject so far. In addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. In this study, we address differences between two dialysis vascular access types in elderly or frail patients. We will compare TCCs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a Charlson Comorbidity Index \>6 independent of age. In our hypothesis TCCs will be superior to arteriovenous fistulas in this population regarding the examined end-points.


Eligibility Criteria:
Inclusion Criteria:

* Age of 60 and higher
* CCI Score \>6 when under 60 years
* Patients with CKD G5 A1-3 with indication for hemodialysis
* Stable clinical condition
* Eligibility for both arteriovenous fistula on the upper extremitiesandTCC
* Availability for follow-up.
* Written informed consent.

Exclusion Criteria:

* Uncontrolled infection at screening and/or CRP \>5 mg/dl (normal \<0.5 mg/dl) at screening.
* Poor general condition of health or malignancy not in remission at screening
* Major surgery within 12 weeks before screening.
* Pre-existent vascular access.
* Patient not eligible for any one of the vascular access options.
Assessing Factors in Tinnitus Patients' Clinical Study Experiences

Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative.

The goal is to identify the obstacles and challenges that prevent participation in tinnitus clinical studies, as well as the reasons for withdrawal or discontinuation.

The insights gained from this study will ultimately benefit those with tinnitus who may be invited to participate in clinical research in the years to come.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with tinnitus
* Willing to comply with all study related procedures and assessments
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* No documented diagnosis of tinnitus
* Any other health problems that would prohibit safe participation in the study
* Pregnant or planning to become pregnant while enrolled in the study
Vinorelbine and Gemcitabine Combination In Platinum Resistant Recurrent Ovarian Cancer

The purpose of this study is to evaluate the objective response rate and safety in platinum-resistant epithelial ovarian/fallopian tube/primary peritoneal cancer patients treated with vinorelbine and gemcitabine combination chemotherapy.

Other objectives of this study are to evaluate Progression-free survival and measure CA-125 response rate.

Eligibility Criteria:
Inclusion Criteria:

* Participants must sign an approved informed consent form (ICF)
* Histologically or cytologically confirmed epithelial ovarian/fallopian tube/primary peritoneal carcinoma
* Patients had to have received a front-line, platinum/taxane based chemotherapy regimen
* Patients who progressed or whose best response to their most recent platinum-based therapy was less than a partial response will be classified as having platinum-refractory/resistant ovarian cancer or progressed within six months of completing the most recent platinum-based chemotherapy
* Participants must have received prior platinum-based chemotherapy for management of primary disease but must not have received more than 3 prior systemic cytotoxic regimens.
* Patients had to have at least one bidimensionally measurable and/or evaluable (unidimensionally measurable) target lesion in a non-irradiated area and increased Ca 125
* A \>= 4 weeks interval between their last chemotherapy regimen and the start of study treatment
* Age 20-75 years old
* Performance status (WHO) 0-2
* Life expectancy of at least three months
* Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3)
* Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2 mg/dl)

Exclusion Criteria:

* prior therapy with vinorelbine or gemcitabine
* treatment with \> 2 cytotoxic regimens (including primary platinum and taxane chemotherapy)
* Serious comorbidities (as determined by the investigator) such as, but not limited to, active congestive heart failure, recent myocardial infarction or active infection.
* Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
* Symptomatic central nervous system (CNS) metastasis.
* Uncontrolled intestinal obstruction
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational
* Pregnant or nursing.
Predictors and Outcomes of Intraoperative Hypothermia in Patients Undergoing Knee Arthroplasty

The study is designed to retrospectively assess the risk factors associated with intra-operative hypothermia in patients undergoing total knee arthroplasty from January 2016 to December 2017 at Aga Khan University and also understand it's impact on post-operative outcomes.


Eligibility Criteria:
Inclusion Criteria:

* All adults greater than 18 years who underwent total knee arthroplasty.

Exclusion Criteria:

* Any patient below 18 years
Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep

In this study the investigators will explore whether the motion during sleep of people with diabetes changes as a function of the blood glucose levels. The motion will be assessed with a radar sensor, a thermal camera, and wrist worn smartwatches. Additionally, participants will answer a short daily questionnaire. Data will be collected for 10 days and analyzed at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent as documented by signature
* Age ≥ 18 years
* Patients at the outpatient clinics or from a referring diabetologist with a diagnostic CGM according to best medical practice
* Patients with diabetes mellitus on an insulin therapy or with non-insulin antidiabetic medication with the potential to induce hypoglycemia
* HbA1c value between 6% and 10% (inclusive) within 6 months prior to inclusion

Exclusion Criteria:

* Wearables cannot be attached around the wrist of the patient
* Known allergies to components of the wearables
* Female subjects: pregnancy, lactation period, lack of a negative urine pregnancy test (except in case of menopause, sterilization or hysterectomy), or unwilling to use a contraception during the study (for sexually active subjects of childbearing potential)
* Known cardiac arrhythmia (e.g., atrial flutter or fibrillation, Atrioventricular-reentry tachycardia, Atrioventricular block \> grade 1)
* Pacemaker or ICD (implantable cardioverter defibrillator)
* Treatment with antiarrhythmic drugs or beta-blockers
* Drug or alcohol abuse
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
* Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
* Any illness or use of medications that could affect sleep patterns (including sleep apnea)
* Dependency from the sponsor or the clinical investigator
* Participation in another investigation with an investigational drug or a pre-market medical device within the 30 days preceding and during the present investigation
Infant Formula Supplemented With a Special Fat Formulation for Premature Infants Following Discharge From Hospital

The purpose of this study is to compare the efficacy and nutritional suitability of 2 infant formulas supplemented with different levels of LCPUFA, for premature infants following discharge from Hospital.


Eligibility Criteria:
Inclusion Criteria:

* premature infants of gestational age 32-34 weeks and AGA birth weight who are healthy at time of discharge.
* whose mothers are unable to breast feed or have chosen not to breast feed,
* Whose parents have signed the informed consent form.
* Only the first among twins will be recorded for the study.

Exclusion Criteria:

* Chromosomal abnormalities or congenital malformation.
* Metabolic abnormalities.
* Central nervous system abnormalities.
* Severe developmental disorders.
* GI problems, GI surgery, necrotizing enterocolitis (NEC), gastro-esophageal reflux disease (GERD) requiring nutritional intervention.
* Milk allergy or intolerance.
* Growth failure.
* Chronic disease
Study of NTx®-265: Human Chorionic Gonadotropin (hCG) and Epoetin Alfa (EPO) in Acute Ischemic Stroke Patients

The purpose of this study is:

* To assess the neurological outcome in acute ischemic stroke patients treated with NTx®-265, when compared with patients given a placebo control.
* To assess the safety and tolerability of NTx®-265 when given to acute ischemic stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-85
* NIHSS score 8-20
* Stroke is ischemic in origin, supratentorial, and radiologically confirmed
* Patient is 24-48 hours from time of stroke onset when the first dose of NTx®-265 therapy is administered
* Reasonable expectation of availability to receive the full 9 day NTx®- 265 therapy and subsequent follow-up visits
* Reasonable expectation that patient will receive standard post-stroke physical, occupational, speech, and cognitive therapy as indicated
* Female patient is either not of childbearing potential or agrees to use two of the effective separate non-hormonal forms of contraception throughout the study

Exclusion Criteria:

* Patients presenting with lacunar, hemorrhagic and/or brain stem stroke
* Patients who have received tissue plasminogen activator (tPA)following the index stroke
* Patients classified as comatose
* Women who have tested positive for pregnancy, or are breast-feeding, or are not using a birth control
* Serum hemoglobin \> 16 grams(g)/deciliter (dL)(males) or \> 14 g/dL (females); or platelet count \> 400,000/cubic millimeters(mm3)
* Advanced liver, kidney, cardiac, or pulmonary disease
* Elevated serum bilirubin,alkaline phosphatase, aspartate aminotransferase (AST) or alanine transaminase (ALT),creatinine, or prostate-specific antigen (PSA) levels
* Patients with a known history of hypercoagulability
* Expected survival \< 1 year
* Allergy or other contraindication to hCG or EPO
* A known diagnosis of cancer in the previous 5 years
* Uncontrolled hypertension
* Use of either hCG or epoetin alfa within the previous 90 days
* Any condition known to elevate hCG
* Patients with a pre-stroke/pre-morbid modified Rankin Score (mRS)≥ 2
* Any patients not living independently
* Any other medical condition or degree of stroke such that, in the investigator's opinion, the patient should not be included in the trial
* With the exception of the qualifying stroke, any other stroke within the previous 3 months
* Patients who cannot take anti-platelet or anti-coagulant therapy
* Pre-existing and active major psychiatric or other chronic neurological disease
* Alcohol abuse or have a history of substance abuse or dependency within 12 months prior to the study
* Currently participating in another investigational study
NestaCell® Mesenchymal Stem Cell to Treat Patients With Severe COVID-19 Pneumonia

This is phase II study to assess the efficacy of NestaCell® (mesenchymal stem cell) to treat severe COVID-19 pneumonia.

The number of infections of COVID-19 worldwide has killed thousands and is continually rising. The novel coronavirus attacks the human body by attaching to the angiotensin-converting enzyme-2 (ACE2), a protective enzyme against lung damage. In addition, the cellular serine protease TMPRSS2 for HCoV-19 Spike protein priming is also essential for the host cell entry and spread. Coronaviruses can be deadly, in large part because they cause "cytokine storms." These storms result from imbalances between pro-inflammatory and anti-inflammatory proteins called cytokines, which can cause extreme inflammation and respiratory complications. Respiratory distress kills hundreds of thousands of people each year worldwide, and hundreds of clinical trials are testing drugs to treat it.

MSCs have been widely used in cell-based therapy, from basic research to clinical trials Safety and effectiveness have been clearly documented in many clinical trials, especially in the immune-mediated inflammatory diseases.

NestaCell® is a mesenchymal stem cell therapy produced by Cellavita and proved to be safe in previous clinical trials.

The aim of this study is assess the efficacy of NestCell® as an add-on therapy to standard treatment to treat patients with severe COVID-19 pneumonia. .

Patients included will be randomized to receive 2x10\^7 cells (20 million cells) on days 1, 3, 5 and 7.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, aged ≥ 18 years 2. Present a confirmed or pending diagnosis of COVID-19, but with tomographic and clinical signs strongly suggestive of SARS-CoV-2 infection (COVID-19), with pulmonary impairment greater than or equal to 50% and: i. Oxygen saturation \<95%; ii. CURB-65 rating ≥ a 4; d) Participants with a score on WHO ordinal scale that measures illness severity over time equal to 5 (Hospitalized with non-invasive ventilation or high-flow oxygen).

Exclusion Criteria:

1. Patients with autoimmune diseases in the past or screening;
2. Those who have serious basic diseases that affect their survival, including: malignant tumor, hematopathy, malignant fluid, active hemorrhage, severe malnutrition, etc. which have not been controlled and can not be removed due to multiple metastasis;
3. Known or self-reported HIV or syphilis infected persons;
4. Have participated in stem cell clinical research;
5. Pregnant or lactating women or those who have fertility plans in the past year;
6. The estimated life cycle is less than 48 hours;
7. Other conditions that the researcher thinks are not suitable for participating in the experiment.
8. Shock
9. Continuous use of immunosuppressive agents or organ transplants in the past 6 months;
Does the Length of Hospital Stay for Rehabilitation Affect Functional Outcomes in Stroke Patients

The purpose of this study was to evaluate whether the length of hospital stay for rehabilitation affects functional outcomes of stroke patients.

The medical records of patients who were admitted to a rehabilitation unit were analyzed retrospectively. The functional output, the level of spasticity, and the level of motor development at admission and discharge will be determined using the Functional Independence Measure instrument, the Modified Ashworth Scale, and the Brunnstrom test, respectively. Based on the length of hospital stay, patients will be divided into two groups: hospital stays ≤ 3 months (Group 1) and \> 3 months (Group 2). Clinical features and functional output will be compared between the groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stroke
* must be able to receive rehabilitation in an inpatient clinic between 2010 and 2013

Exclusion Criteria:

* previous history of stroke,
* other neurological diseases,
* amputation,
* severe arthritis
* undergoing hemodialysis
The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital

The aim of this study is to investigate the effect of a multi-component exercise program on physical function, physical activity and health-related quality of life (HRQOL) in older people recently discharged from hospital. The intervention consists of 32 group-based exercise sessions, performed twice a week. In addition the participants in the intervention group will be encouraged to perform an exercise program on their own, at least once weekly. The participants in the control group will be encouraged to exercise on their own, according to the World Health Organization (WHO) recommendations on physical activity for adults aged 65 and above.

Older people who have been hospitalized often experience loss of function, increased risk of falls and reduced health-related quality of life (HRQOL) in the post-discharge period. The reason for this is the cumulative effect of illness, bedrest during hospital stay and inactivity after discharge. Previous research indicates that exercise therapy should be an integrated part of the post-hospital treatment to prevent or postpone this functional decline and improve HRQOL. Therefore, the investigators will conduct a randomized controlled trial to investigate the effect of a multi-component exercise program consisting of high intensity exercises on physical function, physical activity and HRQOL among older people living at home after discharge from hospital after treatment of an acute medical event.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or older, live in their own home, consent to participate in the program three times a week (twice a week outside their home), manage to walk with or without assistive device, and assessed by a doctor as able to tolerate the intervention.

Exclusion Criteria:

* Severe cognitive impairment (Mini-Mental State Examination (MMSE) score less than 20), have an expected lifespan less than one year, exercise more than twice a week, and score above nine points on the Short Physical Performance Battery.
Treatment for Women With Post-Traumatic Stress Disorder Related to Childhood Abuse

This study will compare one- and two-component treatments in women with post-traumatic stress disorder (PTSD).

PTSD is a debilitating and often chronic anxiety disorder with serious psychiatric comorbidity. The most common trauma associated with PTSD among women is childhood abuse. PTSD related to childhood abuse may cause problems with emotion regulation and interpersonal functioning. This study will address three domains of PTSD related to childhood abuse: emotion management problems, interpersonal problems, and PTSD symptoms.

Participants in this study will be randomly assigned to 16 sessions of one of three treatments: Skills Training for Affective and Interpersonal Regulation (STAIR), which focuses on helping individuals strengthen and build skills in managing feelings and improving interpersonal relationships; Modified Prolonged Exposure (MPE), which focuses on developing narratives of abuse history and completing an "emotional processing" of the trauma in a safe environment; and a combination of STAIR and MPE. Dropout rates and adverse effects will be measured.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for Post-Traumatic Stress Disorder related to childhood physical and/or sexual abuse by a care-giver
* At least one clear memory of the abuse
* Willing to have all assessments tape recorded and sessions video taped
* Willing to maintain any concurrent treatments for the duration of the study

Exclusion Criteria:

* Bipolar Disorder
* Eating Disorder
* Borderline Personality Disorder
* Active substance abuse or dependence
* Living with the abuser
* Self mutilation
* Pregnancy
Osteogenesis Imperfecta and Balance

Osteogenesis Imperfecta (OI), also known as brittle bone disease, is a group of genetic disorders that mainly affect the bones. It results in bones that break easily. Its severity may be mild to severe. Other symptoms may include a blue tinge to the whites of the eye, short height, loose joints, hearing loss, breathing problems and problems with the teeth.

Physiotherapy is aimed to strengthen muscles and improve motility in a gentle manner, while minimizing the risk of fracture, and the use of support cushions to improve posture.

This study aimed to assess the efficacy of Whole Body Vibration on balance and motor function in children with Osteogenesis Imperfecta.

Whole body vibration (WBV) therapy is targeted at musculoskeletal strengthening and has been trialed in a variety of conditions. WBV has been shown to have therapeutic advantage in various osteopenic preclinical models and populations such as postmenopausal women (improved mobility, muscle strength, postural strength, and bone density) and children with osteogenesis imperfecta (improved mobility)

Eligibility Criteria:
Inclusion Criteria:

1. Their age was ranging from six to twelve years
2. Children participated in this study were from both sexes
3. All children with stable medical and psychological status.
4. They were able to follow the verbal commands or instructions during testing.

Exclusion Criteria:

1. Children with visual or auditory problems.
2. Children with any cognitive problems.
3. Children without deformity
Study Evaluating Nasal Symptoms Induced by a Nasal Allergen Challenge (NAC) To House Dust Mite Allergen

A Multi-Center Study Evaluating the Nasal Allergic Symptomatology Induced by a Nasal Allergen Challenge (NAC) in a Dust Mite Population


Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* positive ST to Dust Mite
* history of allergic rhinitis

Exclusion Criteria:

* no active infections
* no disallowed medications
* no nasal anatomical deformities or nasal surgical interventions in the past