cyrilzakka/clinical-trials huggingface dataset:
Acute Cognitive and Neurobehavioral Intervention: Efficacy Evaluation

To learn more about behavior and everyday functioning after brain injury, and to learn if behavior and functioning gets better with more education about changes after brain injury.

To evaluate the efficacy of the First Steps intervention for improving neurobehavioral functioning, functional status, and life satisfaction, and for increasing knowledge about TBI and compensatory strategies. The First Steps program was developed to address the neurobehavioral and emotional concerns of survivors of TBI during the course of inpatient rehabilitation. Program format and content reflects clinical experience and extensive research review. Input from survivors, family members, and rehabilitation staff trained in working with the TBI population has also helped shape the implementation protocol. The foundation of the protocol is a curriculum \[Niemeier, J., Kreutzer, J., \& Taylor, L. (2005). Acute cognitive and neurobehavioral intervention for individuals with acquired brain injury: Preliminary outcome data. Neuropsychological Rehabilitation, 15(2), 129-146.\] The First Steps curriculum consists of ten lessons and was developed to address the common needs, issues, and concerns of TBI survivors admitted acutely for inpatient rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* adults (18 years or older) who have experienced a TBI (damage to brain tissue caused by an external mechanical force as evidenced by: loss of consciousness due to brain trauma, or post traumatic amnesia, or skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination).

Exclusion Criteria:

* imminent risk of psychiatric hospitalization, or in imminent danger of hurting themselves or others.
* unable to tolerate treatment sessions due to physical, cognitive, behavioral, or other difficulties.
Imipenem Prophylaxis in Patients With Acute Pancreatitis

This is a prospective, single-center, randomized, placebo-controlled, double-blind clinical trial that aims to investigate the beneficial and harmful effects of prophylactic use of imipenem in patients with predicted severe acute pancreatitis. All patients with first attack of acute pancreatitis, an onset of disease less than 72h before admission, and an APACHE II score ≥ 8 calculated within the first 24h from admission will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of acute pancreatitis defined by the Revised 2012 Atlanta Criteria
* first manifestation of acute pancreatitis regardless of etiology
* APACHE II ≥ 8 calculated within the first 24 hours of admission
* onset of symptoms \< 72 hours before admission

Exclusion Criteria:

* age \< 18 years
* pregnant and breastfeeding women
* active and documented infection at admission
* concomitant antibiotic treatment or antibiotic treatment present within 72 hours before enrollment
* acute pancreatitis diagnosed at surgery
* active malignancy
* known immune deficiency
* patients with chronic pancreatitis
* patients unwilling to participate in the trial
ZK-Epo Given With Prednisone in Patients With Metastatic Androgen-independent Prostate Cancer

The purpose of this study is to evaluate whether treatment with a new drug called ZK-Epothilone (ZK-Epo) given with prednisone in patients with androgen-independent prostate cancer, who have not had previous chemotherapy, is safe and helps to decrease PSA (Prostate-specific antigen) levels.

This study has previously been posted by Berlex, Inc. and Schering AG, Germany.Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer Schering Pharma AG, Germany. Bayer HealthCare Pharmaceuticals, Inc.and Bayer Schering Pharma AG, Germany are the sponsors of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Must have evidence of confirmed metastatic prostate cancer
* Serum testosterone must be less than 50 ng/mL
* Disease must be progressing despite anti-androgen therapy
* PSA level must be elevated
* Additional criteria determined at screening visit

Exclusion Criteria:

* Any previous cytotoxic chemotherapy for prostate cancer
* Use of any investigational drug in the last 4 weeks
* Symptomatic brain tumors requiring radiation to the brain
* Active infection
* Additional criteria determined at screening visit
Compressive Myofascial Release in Knee Osteoarthritis

The purpose of the study is to compare the effects of compressive myofascial release and conventional knee osteoarthritis treatment to correct lateral patellar tracking. A randomized control trial was conducted at Railway General Hospital, Ahad Medicare clinics and physiotherapy Centre and The Health Professional physiotherapy clinic Bahria town phase 6. The sample size was 52 calculated through open-epi tool. The participants were divided into two interventional groups each having 26 participants. The study duration was six months. Sampling technique applied was non probability convenient sampling for recruitment and group randomization using sealed enveloped method. Only participants who were 50 years above with grade 2 and 3 knee osteoarthritis were included in the study. Tools used in this study are Q angle, numeric pain rating scale, goniometry and WOMAC questionnaire, Self structured Questionnaire. Data was collected at baseline, at the end of 3rd session and 6th session. Data analyzed through SPSS version 23.

knee osteoarthritis is commonly manifested as decreased joint space, sub chondral bone sclerosis, bony spur formation, cartilage loss and mainly lateral patellar tracking(2).Lateral patellar tracking is a condition in which patellar move laterally in relation to femoral groove on flexion and extension(4). Patellofemoral disorders are very common in patients of knee OA. One of the very common manifestation of which is lateral patellar tracking(5). Patella move laterally due to certain disorders of knee that include patellofemoral pain syndrome and anterior knee pain. Q-angle is used as an indicator of patellofemoral pain syndrome. When Q angle exceeds its normal limit i.e. 15-20 degrees it leads to lateral mal positioning of patella(6). Rozenfeld, E et al. in 2019 conducted a cross sectional study with a diagnosis of anterior knee pain that suggests highest prevalence of myofascial trigger points in distal vastus lateralis and mid and distal vastus lateralis. It also reported that presence of trigger points in anterior knee pain(7). There are several techniques that are used to release trigger points.

Eligibility Criteria:
Inclusion Criteria:

* Includes diagnosed cases of knee osteoarthritis
* Grades 2-3 according to the Kellgren and Lawrence method of grading(1)
* Includes patients from the age group of 50 years and above(3)
* Includes knee osteoarthritis patients with lateral tracking of patella which will assessed through Q angle test(4)

Exclusion Criteria:

* history of recent trauma to knee
* History of hip disease
* Past history of knee surgery/arthroplasty
* Intraarticular corticosteroid injection
A Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Antiretroviral Therapy (ART) (MK-8591A-051)

The primary objectives of this study are to evaluate the safety and tolerability of a switch to Doravirine/Islatravir (DOR/ISL) compared with continued baseline antiretroviral therapy (ART), through Week 48; and to evaluate the antiretroviral activity of a switch to DOR/ISL compared with continued baseline ART at Week 48. The primary hypothesis is that DOR/ISL is non-inferior to continued baseline ART, as assessed by the percentage of participants with HIV-1 ribonucleic acid (RNA) ≥50 copies/mL at Week 48, with a margin of 4 percentage points used to define non-inferiority.


Eligibility Criteria:
Inclusion Criteria:

* Is HIV-1 positive with plasma HIV-1 RNA \<50 copies/mL at screening
* Has been receiving continuous, stable oral 2-drug or 3-drug combination (± PK booster) ART with documented viral suppression (HIV-1 RNA \<50 copies/mL) for ≥3 consecutive months prior to providing documented informed consent and has no history of prior virologic treatment failure on any past or current regimen
* Female is not a participant of childbearing potential (POCBP); or if a POCBP uses an acceptable contraceptive method or abstains from penile-vaginal intercourse as their preferred and usual lifestyle; has a negative highly sensitive pregnancy test; and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator

Exclusion Criteria:

* Has HIV-2 infection
* Has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator
* Has a diagnosis of an active acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 30 days prior to screening
* Has active hepatitis B virus (HBV) infection
* Has chronic hepatitis C virus (HCV) infection consistent with cirrhosis
* Has a ≤5 years prior history of malignancy
* Is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or strong and moderate cytochrome P450 3A (CYP3A ) inducers
* Has taken long-acting HIV therapy at any time
* Is currently participating in or has participated in a clinical study and received (or is receiving) an investigational compound or device from 45 days prior to Day 1 through the study treatment period
* Has a documented or known virologic resistance to DOR
Screening for Sleep Disordered Breathing With Minimally Obtrusive Sensors

The purpose of this study is to learn more about breathing disorders during sleep. The investigators want to learn how breathing sounds made during sleep relate to breathing disorders during sleep.

The purpose of this study is to evaluate the feasibility of assessing breathing problems during sleep with minimally obtrusive sensors (a bedside microphone and wireless pulse oximeter worn on the fingertip). The investigators will use the data collected with these sensors to develop algorithms for automatically detecting sleep apnea events. Subjects will be asked to place unobtrusive sensors (bedside microphone and wireless pulse oximeter) in their home sleep environment. The subjects will start the at-home data collection before they fall asleep, and stop the data collection the next morning when they wake. The subjects will then return the sensors to the investigator for analysis.

We are looking for people interested in participating in the at-home portion of our study. We will only collect at-home data for one night of sleep per subject. After this one night, no further data collection or monitoring will occur. Subjects will be compensated for their time.

A standard sleep-breathing questionnaire (the "Berlin Questionnaire") will be administered. This questionnaire is widely used as a screening tool to determine if a person may have disordered breathing during sleep. This questionnaire consists of 10 multiple-choice questions related to snoring, daytime sleepiness, and other related conditions.

Eligibility Criteria:
Inclusion Criteria:

* Age 21-89
* No self-reported sleep breathing problems

Exclusion Criteria:

* Prior diagnosis for a sleep breathing problem (such as sleep apnea)
* Self-reported insomnia
* History of stroke
* Nasal or soft palate surgery in the last 12 months
* Use of a breathing assistance device (such as a CPAP machine)
Outcome of Babies With Asymetry of Lateral Brain Ventricles

The investigators will follow up on babies that had prenatal diagnosis at 2nd or 3rd trimester of normal width and asymetry of lateral brain ventricles

Women who will attend 2nd or 3rd ultrasound prenatal scans will be included. Women where the fetus would be diagnosed with lateral ventricles that are normal width (\<10 m"m) but discrepacy of \>3 m"m will be followed up after delivery by head ultrasound and neurologic exam

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women between 19-30 weeks gestational age and asymetry of lateral ventricles

Exclusion Criteria:

* Lateral ventricles \>10 m"m
Angiotensin (1-7) for the Treatment of COVID-19 in Hospitalized Patients

The primary objective is to evaluate the safety and efficacy of intravenous (IV) infusion of Ang (1-7) compared to placebo with respect to time to recovery, disease severity, need for mechanical ventilation or extracorporeal membrane oxygenation (ECMO), and mortality in patients with COVID 19.


Eligibility Criteria:
Inclusion Criteria:

* Signs and symptoms suggestive of COVID-19 infection including cough or dyspnea
* Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) test ≤7 days before randomization
* Currently hospitalized or in an emergency department with planned hospitalization
* Peripheral capillary oxygen saturation (SpO2) ≤93% on room air or partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) \<300 at Screening

Exclusion Criteria:

* Simultaneous participation in any other clinical study incompatible with this one
* Treatment with an antibody immunotherapy that is not standard of care for COVID-19 within 4 weeks of Screening
* Requirement for mechanical ventilation or ECMO at Screening
* Hypotension at Screening, defined as supine BP \<95 mm Hg systolic or \<55 mm Hg diastolic
* Severe liver injury defined as AST or ALT ≥5x the upper limit of normal
* Severe kidney failure defined as an estimated glomerular filtration rate (eGFR) \<30 mL/min
* Any known immune deficiency
* Pregnancy or breastfeeding
Vitamin D Deficiency in Adults Following a Major Burn Injury

This is a single site double blind randomized controlled trial of replacing Vitamin D for Vitamin D-deficient burn patients at a current recommended dose (400 IU daily) versus a higher dose (4000 IU daily). Capsules will be made in a compounding pharmacy and will look identical.

Randomized controlled trial. People who meet the selection criteria will be randomized to either low or high dosage of Vitamin D. Treatment arm is high dose Vitamin D (4000 IU), and control is low dose Vitamin D (400 IU). Main outcome variables include PROMIS-29 measures of physical health, mental health and social health, the Veterans RAND 12 Item Health Survey (VR-12), and the 4-D Itch Scale. Secondary outcome variables include subject demographics, injury demographics and characteristics.


Eligibility Criteria:
Inclusion Criteria:

1. Adults, 18 years of age or older, who have completed 6 months from time of their burn injury
2. ≥ 10% TBSA, ≥ 65 years of age and Burn Surgery for Wound Closure
3. ≥ 20% TBSA, 18 - 64 of age and Burn Surgery for Wound Closure
4. Electrical high voltage / lightning and Burn Surgery for Wound Closure
5. Hand burn and/or face burn, and/or feet burn and Burn Surgery for Wound Closure
6. May speak English or Spanish
7. Vit. D deficiency

Exclusion Criteria:

1. Patients with parathyroid disease, severe liver dysfunction, sever kidney dysfunction, which are not caused by the burn injury
2. Patients with malignant tumors
3. Patients not meeting the inclusion criteria
Evaluation of the Effectiveness of Transforaminal Epidural Injections in Lumbar Disc Herniation or Radiculitis

To evaluate differences in outcomes in patients receiving steroids compared to those patients randomized to the local anesthetic group who did not receive steroids.

To evaluate and compare the adverse event profile in all patients.

Recruitment is indicated in patients with chronic low back and lower extremity pain secondary to lumbar disc herniation and/or lumbar radiculitis of at least 6-months duration, non-responsive to conservative management with NSAIDs, physical therapy, chiropractic treatment, and exercises.

This is a single center study performed in an interventional pain management referral center in the United States.

The study involves 120 patients studied in 2 groups with 60 patients in each group. Randomization includes sequence generation, allocation concealment, implementation, and blinding.

Data management analysis includes sample size justification of 40 patients in each group with a power of 80% and a 0.05% 2-sided significance level. Statistical methodology includes chi-squared statistics, Fisher's exact test, t-test, and paired t-test with significance evaluated at P value \< 0.05.

Eligibility Criteria:
Inclusion criteria:

* Patients with disc herniation or radiculitis
* Patients who are 18 years of age
* Patients with a history of chronic function-limiting low back and lower extremity pain of at least 6 months duration
* Patients who are competent to understand the study protocol and provide voluntary, written informed consent and participate in outcome measurements

Exclusion criteria:

* Previous lumbar surgery, radiculitis secondary to spinal stenosis without disc herniation
* Uncontrollable or unstable opioid use
* Uncontrolled psychiatric disorders
* Uncontrolled medical illness either acute or chronic
* Any conditions that could interfere with the interpretation of the outcome assessments
* Pregnant or lactating women
Investigation of a Medical Device for the Immobilisation of Radius and Ulna Fractures in Paediatric Patients

Single-centre, randomised, controlled, non-profit study on a custom-made medical device for immobilisation of radius and ulna fracture in paediatric patients.

The aim of the study is to evaluate the benefits in terms of comfort, safety and efficacy resulting from the use of a customised 3D-printed wrist immobilisation device in children aged between 7 and 13 with a fracture of the distal metaphysis of radius or ulna of the 'green stick' type, compared to a control group treated with traditional immobilisation devices. The patients will be randomised between use of customised 3D- printed wrist immobilisisation device and plaster.

The device under investigation has already been the subject of a pilot study (clinical investigation code: T3DDY01) with significant result. These results are also preparatory to the proposed new investigation, which aims to extend its applicability to more complex clinical conditions. Compared to the previous one, the new study will be able to take advantage of an improved acquisition process of the anatomy of the child's upper limb, obtained by updating the model of the chambers used.

The aim of the study is to evaluate the benefits in terms of comfort, safety and efficacy resulting from the use of a customised 3D-printed wrist immobilisation device in children aged between 7 and 13 with a fracture of the distal metaphysis of radius or ulna of the 'green stick' type, compared to a control group treated with traditional immobilisation devices. The patients will be randomised between use of customised 3D- printed wrist immobilisisation device and plaster.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 7 and 13 years with compound fracture of the distal metaphysis of radius and/or ulna at "green wood" and initial angulation \<20°;
* Informed consent obtained.

Exclusion Criteria:

* Complete fracture of radius and ulna;
* Open fracture of radius and ulna;
* Polytrauma, polyfracture;
* Presence of neurovascular deficit at presentation;
* Presence of underlying bone disease;
* Presence of acute or chronic skin disorders;
* Psycho-behavioural disorders;
* Presence of ≥1 skin lesions according to NPUAP/EPUAP classification;
* Specific allergies related to the materials used in the tested device;
* Inability to perform follow-up examinations.
Effectiveness and Safety of Omalizumab in Children With Allergic Asthma.

The study was the non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab in real-world practice.

This non-interventional, retrospective study aimed to assess the effectiveness and safety of omalizumab in children with allergic asthma in China, and described patient profiles and treatment patterns of omalizumab in real-world practice. This study was designed to use secondary data from medical charts of 25 hospitals. Medical records were reviewed to collect information such as demographics, clinical characteristics, treatment patterns, effectiveness, and AEs for retrospective analysis. Patients with allergic asthma aged 6 -\<12 years treated with omalizumab from July 6, 2018 to September 30, 2020 were identified for medical chart extraction.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 6 -\<12 years
* Diagnosed with allergic asthma and could be treated using omalizumab. Comorbidities included allergic rhinitis, atopic dermatitis, nasal polyp, chronic urticaria, and food allergy
* Received omalizumab during the identification period
* Had at least one documented follow-up data after omalizumab treatment
* Provided informed consent if required by ethics committee (EC) of hospital

Exclusion Criteria:

* Current participation in a clinical trial of any investigational treatment
Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology

When the digestive tract is functional, learned societies recommend the use of a nutritional support by enteral feeding. Indeed, it has many advantages (maintenance of gut trophicity, reduction of the risk of infection by reducing the incidence of bacterial translocations,...). It has been used for about fifteen years in hematology departments and offers promising results in the context of allogeneic transplantation with prospective trials in progress (NEPHA study). However, its tolerance has not been studied during autologous transplantation. This study aims to assess the success of enteral nutrition in this setting.

In the literature, there are many studies on the nutritional support to be used during allografts, that highlight the superiority of enteral nutrition over parenteral nutrition in terms of reducing co-morbidities.

Enteral nutrition is the nutritional support recommended by learned societies for therapeutic intensification with autograft of autologous hematopoietic cells in hematology. Nevertheless, enteral nutrition presents difficulties in its implementation and failures (refusal of patients, probes vomiting, neutropenic colitis, etc.), requiring the use of parenteral nutrition in case of failure.

In this context, the study proposes to assess the success and effectiveness of enteral nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Patient with lymphoma or myeloma
* Patient admitted for therapeutic intensification with autologous hematopoietic cells who are eligible for nutritional support by enteral nutrition
* Free, informed and written consent signed by the patient

Exclusion Criteria:

* Refusal of the enteral nutrition
* All patients with absolute or enteral nutrition contraindications:
* Digestive fistula
* Intestinal obstruction
* Intestinal ischemia
* Active digestive bleeding
* Digestive malabsorption (short hail syndrome, bariatric surgery, gastrectomy)
* Trauma to the base of the skull or significant deviation of the nasal septum not allowing the insertion of an naso gastric probe.
* Esophagitis or barrett's esophagus
* Persistent gastro-duodenal dysfunction (gastroparesis)
* Patients admitted for autograft for the treatment of conditions other than lymphoma or myeloma (e. g. solid tumours or leukaemia)