cyrilzakka/clinical-trials huggingface dataset:
Neural Mobilization With Intermittent Cervical Traction on Grip Strength, Sleep Quality, and Quality of Life in Cervical Radiculopathy

Cervical radiculopathy commonly called "pinched nerve," occurs when a nerve in the neck is compressed or irritated where it branches away from the spinal cord. This may cause pain that radiates into the shoulder and/or arm, as well as muscle weakness and numbness.

Cervical radiculopathy (CR) is a disorder of the peripheral nervous system that affects the normal function of the cervical nerve roots (CNRs). It is frequently linked to chronic pain and daily functional limitations. The goal of the neural tissue mobilization technique is to restore the nervous system's capacity to tolerate the normal compressive, tensile, and frictional forces that are associated with day-to-day activities and to examine the neural tension in nerves and mobilize the nerves that exhibit neural tension through passive and active movements using tensioning and gliding. Cervical traction reduces pressure within the vertebral disks and unloads the structures of the spine by stretching muscles and ligaments. They are clinically important techniques that are easily understood by patients.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects of any gender
2. Age between 35 and 55 years
3. Experience of unilateral upper-extremity pain, numbness, or paranesthesia. This must include a history of neck pain associated with radicular pain below the occiput and on one side of the neck, along with a tingling sensation on the lateral aspect of the elbow joint.
4. Positive results in at least three out of four tests Spurling's test, Distraction test, Upper Limb Neurodynamic Test 1, and ipsilateral cervical rotation of less than 60°, according to a clinical prediction rule.

Exclusion Criteria:

1. History of previous cervical or thoracic spine surgery
2. Bilateral upper-extremity symptoms
3. Signs or symptoms of upper motor neuron disease
4. Medical "red flags" (e.g. tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)

4. Injections in cervical spine in the past 2 weeks
Safety, Pharmacokinetics and Pharmacodynamics of Single Rising Doses Oral BIRB 796 BS in Healthy Human Subjects

To assess safety, pharmacokinetics and pharmacodynamics of BIRB 796 BS in escalating single doses, with and without a 64 g fat breakfast at one selected dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age \>= 18 and \<= 45 years
* Broca \>= -20% and \<= +20%

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant ot the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) (= 1 month prior to administration or during the trial)
* Use of any drugs, which might influence the results of the trial (= 10 days prior to administration or during the trial)
* Participation in another trial with an investigational drug (=2 months prior to administration or during trial)
* Smoker (\> 10 cigarettes of \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation \> 400 ml (=1 month prior to administration of during the trial)
* Excessive physical activities (= 5 days prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance (but not exclusive to) total white cell count \>= 10 x 10\*\*9/L, C-reactive protein \>= 4.5 mg/L, any haemoglobin or \> 15 mg/dl protein on urine dipstick
* History of any familial bleeding disorder
Removing Barriers: Community Partnering for Innovative Solutions to the Opioid Crisis

The opioid epidemic has become one of America's deadliest crises, surpassing car crashes, firearms, and HIV/AIDS as a leading cause of death for Americans under fifty years of age. People trying to recover from opioid-use disorder face many obstacles. Obstacles such as minor legal problems (e.g., arrest warrants for failure to pay a fine, failure to appear in court, or late child support payments) can undermine the stability needed to overcome opioid dependence. Outstanding legal obligations make it difficult to find jobs and to secure housing. They can result in removal from treatment programs as well as incarceration. Resolving these legal problems requires coordination, organization, preparation, travel, and time-expectations that may be problematic for many people in the early stages of recovery. Technology has the potential to make resolving these legal problems much easier. Online platform technology is now available that can guide people in recovery through the resolution of many legal problems at no cost and without an attorney, potentially doing so quickly, remotely, and at any time of day.

This study of individuals in treatment in Michigan tests whether resolving outstanding legal issues improves drug treatment outcomes. The research also examines whether and to what extent resolving legal issues supports family reunification, reduces future criminal behavior, and improves access to jobs and housing for clients in treatment for opioid use disorder. A randomized controlled trial (RCT) is used to determine the effects of resolving legal issues on these outcomes. For identification, the investigators leverage the random assignment of legal services to treatment center clients, along with the random assignment of clients to treatment centers by birth month. We assemble a novel longitudinal dataset of hundreds of clients in treatment for substance use disorder and link these clients to several administrative datasets and qualitative data, which allows for measurement of: (1) substance use behaviors and (2) justice-system involvement, including civil and criminal legal system encounters. This study also uses linked client and administrative data to research the population in opioid treatment centers, follow-up behaviors, and whether the consequences of providing no-cost legal services differ by client background. Findings from this research will improve America's understanding of the acute socio-legal needs faced by those experiencing opioid use disorder and provide recommendations to help target resources toward the areas that best support long-term abstinence from opioids and other drugs.


Eligibility Criteria:
Inclusion Criteria:

\*Receiving substance use disorder treatment services

Exclusion Criteria:

\*Not receiving substance use disorder treatment services
Efficacy of Convalescent Plasma to Treat COVID-19 Patients, a Nested Trial in the CORIMUNO-19 Cohort

The coronavirus disease 2019 (COVID-19) viral pneumonia is now a worldwide pandemic caused by the Severe acute respiratory virus coronavirus 2 (SARS-CoV-2). The number of cases, and associated mortality has increased dramatically since the first cases in Wuhan, China in December 2019 . To date, no specific treatment has been proven to be effective for COVID-19. Treatment is currently mainly supportive, with in particular mechanical ventilation for the critically ill patients (6.1% in a series of 1099 cases in China). Novel therapeutic approaches are in acute need. In this context, the therapeutic potential associated with convalescent plasma needs to be explored.

The objective of COVIPLASM trial (a nested trial in the CORIMUNO-19 COHORT) is to study the efficacy of convalescent plasma to treat SARS-COV2 infected patients.

Hypothesize: early administration of convalescent plasma containing polyclonal neutralizing Abs may inhibit viral entry and replication (as recently suggested in vitro) and consequently blunt an early pro-inflammatory pathogenic endogenous Ab response.

Potential donors of convalescent plasma will be identified through various means, including hospitals taking care of such patient, practitioners treating outpatients or specific social messaging. Convalescent patients at least 14 to 28 days (per at date regulation regarding blood donation) after the symptoms resolution will be invited to undergo plasma apheresis, pending general eligibility such as an age between 18 and 65 years old and weight not less than 50 kg.

Two convalescent plasma units of 200 to 220 ml each will be transfused i.v. as early as possible and no later than 10 days after onset of clinical symptoms. In the absence of acute unforeseen adverse events in the first 3 patients, an additional 2 plasma units of 200/220 ml each will be transfused 24 hours after first 2 units: a total of 4 units / patient. Transfusion monitoring, treatment and reporting of adverse events will be performed per ANSM hemovigilance regulation regarding transfusion of labile blood products as well as through the specific clinical trial vigilance.

An average of 120 participants will be expected (60 participants in each arm). Availability of ABO compatible plasma will be checked by investigator when a Corimmuno patients is eligible. If so, randomization will be undertaken and patient will be offered to participate in this nested trial if he is allocated to the experimental arm.

An interim analysis is performed at mid-trial, but inclusions are not frozen to wait for the interim analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients included in the CORIMUNO-19 cohort
* Onset of COVID19 functional signs \<8 days (plasma transfusion may occur up to day 10 of onset)
* Mild severity as described in the WHO scale

Exclusion Criteria:

* Pregnancy
* Current documented and uncontrolled bacterial infection.
* Prior severe (grade 3) allergic reactions to plasma transfusion
Effects of Marihuana Use on Optic Nerve Parameters and Ocular Blood Flow

Purpose of study: to check the effect of medical cannabis given for approved medical indications on ocular parameters including intra ocular pressure, optic nerve fibers thickness and choroidal thickness.

Purpose of study: to check the effect of medical cannabis given for approved medical indications on ocular parameters including intra ocular pressure, Retinal Nerve Fiber Layer (RNFL) thickness, optic nerve fibers thickness and choroidal thickness.

Adult patients with no ocular pathology that are being treated in the neurology or pain clinics with medical cannabis for different indications, were examined in the eye clinic.

First examination took place after the patient was not smoking for 5 hours. Three more examinations took place 1 hour 3 hours and 5 hours after smoking cannabis.

The following parameters were checked: blood pressure, pulse, visual acuity, intra ocular pressure, corneal thickness, axial length, slit lamp examination of anterior segment, fundoscopy and Optical Coherence Tomography (OCT) of the retina, and optic nerve.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Treated with medical cannabis for approved medical indications

Exclusion Criteria:

* Known ocular pathology
* Topical or systemic treatment for intra ocular pressure
* Previous topical, intra ocular or systemic steroid treatment
Reasons for Non-reversal of Temporary Stomas After Surgeries of Mid-low Rectal Cancer （NORESTO Study）

The goal of this observational study is to learn about in mid-low rectal patients who received temporary ostomies after surgery of the primary tumors. The main questions it aims to answer are:

* To explore the proportion of temporary stomas that cannot be reversed after radical surgery for mid-low rectal cancer and their main causes.
* To use the basic information we collected from patients before and during surgery to develop an individualized model for predicting the time of stoma reversal and explore the risk factors affecting stoma reversal.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed as rectal adenocarcinoma;
* The tumor is located within 12cm from the anal verge;
* Primary tumor is radically resected;
* The patient received a temporary ostomy during the in-hospital visit of the resection of the primary tumor.

Exclusion Criteria:

* The stoma was initially recognized as permanent stoma;
* Patients with distant metastasis;
* Patients with multi-primary colorectal cancer.
A Non-invasive Approach to the Assessment of Volume Status in Mechanically Ventilated Septic Patients.

To evaluate the use of sonographic inferior caval vein assessment in mechanically ventilated septic patients.

Volume assessment in mechanically ventilated patients with inflammation is of major importance to guide fluid therapy. The researchers investigated whether measurement of caval vein diameter correlates with invasively assessed volume-based hemodynamic parameters.


Eligibility Criteria:
Inclusion Criteria:

* age 18-90
* presence of severe sepsis and septic shock
* invasive hemodynamic monitoring using the picco system
Heart Rate Reduction in Heart Failure

Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological interventions have been proven effective in improving exercise capacity. At the presence there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity. Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left ventricular dysfunction and heart rate \> 70 bpm. The association of ivabradine and atenolol has been proven effective in increasing exercise tolerance in patients with ischemic heart disease. Aim of the present study is to evaluate the effect of heart rate reduction with ivabradine, carvedilol or their combination in patients with heart failure of ischemic origin.

Patients with chronic heart failure of ischemic origin (120) Stable coronary artery disease Acute coronary syndromes \> 3 months Revascularization procedures \> 3 months Naive on heart rate reducing agents New York Heart Association (NYHA) Class II III 6 minute walking test (6MW) tolerance between 200 and 400 m Stable medications for the past 3 months

Treatment Ivabradine up to 7.5 mg b.i.d. Carvedilol up to 25 mg b.i.d. Carvedilol and Ivabradine up to 12.5/5 mg b.i.d.

Efficacy measure Intention to treat Exercise tolerance Quality of life

Eligibility Criteria:
Inclusion Criteria:

* heart failure II-III
* ischemic origin
* stable medications from at least 3 months
* \> 3 months from an acute ischemic syndrome or revascularization procedure
* naive on heart rate reducing agents

Exclusion Criteria:

* bradycardia
* hypersensitivity or contraindications to study drugs
* exercise tolerance at 6 minute walking test \<100 m or \>400 m
Living a Pregnancy After a Peri-natal Grief: How Well Does Pregnancy Follow-up Meet Women's Needs and Expectations?

Every year in France, around 7,000 children are born without life, following a medical termination of pregnancy (IMG), fetal death in utero (FDIU) or premature delivery ("late miscarriage"). For families affected by perinatal bereavement, the pregnancy that follows this silent birth is a moment apart, between anguish and guilt, joy and apprehension. The aim of this research project is to improve the understanding of what women go through during the pregnancy that follows, with a view to proposing a practical tool for the professionals who take care of them, in order to improve and personalize their follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Women who have given birth to a stillborn child (singleton or twin pregnancies):

  * delivery following fetal death in utero or medical termination of pregnancy at 15 weeks gestational age and later
  * extreme preterm birth ("late miscarriage") from 15 weeks gestational age Patient who subsequently carried a pregnancy to term and gave birth to a live, viable child between 2020 and 2023.
* French-speaking patient
* Patient who does not object to her participation in this research study

Exclusion Criteria:

* Women who have experienced a natural termination of pregnancy ("early miscarriage") before 15 weeks of amenorrhea.
* Women who have given birth by suction in the operating theatre.
* Women who are pregnant with twins in the pregnancy following bereavement. Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under court protection
Itraconazole in Advanced Ovarian Cancer

This is a randomized, placebo controlled; parallel study that will be conducted on 66 female patients with advanced epithelial ovarian carcinoma (stage III and stage IV) to compare effect of adding Itraconazole to paclitaxel and carboplatin versus placebo to paclitaxel and carboplatin as regard overall response rate (ORR) and Disease control rate (DCR) and Quality of life (QOL) and the change in the serum concentrations of the biological markers.

This is a randomized, placebo controlled; parallel study that will be conducted on 66 female patients with advanced epithelial ovarian carcinoma (stage III and stage IV). The staging of the disease will be done according to 8th edition of American Joint Committee on Cancer (AJCC), TNM staging. The patients will be recruited from Oncology Department, Tanta University Hospital. The patients will receive a combination of paclitaxel and carboplatin chemotherapy with or without itraconazole. Randomization will be carried out based on hospital admission days where the patients will be randomized into the following two groups to compare effect of adding Itraconazole to paclitaxel and carboplatin versus placebo to paclitaxel and carboplatin.

Eligibility Criteria:
Inclusion Criteria:

* Female patients Age \>18 years old \< 65 years old.
* Patients with histopathological and radiological based diagnosis of III, IV epithelial ovarian carcinoma according to 8th edition AJCC, primary tumor, regional nodes, metastasis (TNM) staging system.11
* Patients with Eastern Cooperative Oncology Group Performance Status of 0 or 1. 13
* Patients able to swallow and retain oral medications (without crushing, dissolving, or chewing tablets).
* Patients with adequate hematologic and organ function within 14 days before the first Cycle which can be defined by the following:

  * Neutrophils (absolute neutrophil count (ANC) \>1.5 X 10\^9/L).
  * Hemoglobin \>9 g/dl.
  * Platelet count \>100,000/L.
  * Serum albumin \>3 g/dl.
  * Total bilirubin 1.5 ≤ of the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine transaminase ( ALT) ≤ 2 of the upper limit of normal (ULN).
  * Serum creatinine ≤ 1.5 of the upper limit of normal (ULN) or estimated creatinine clearance \>50 mL/min based on Cockcroft-Gault glomerular filtration rate estimation.

Exclusion Criteria:

* Presence of 2nd primary malignancy
* History of allergic reactions attributed to paclitaxel, carboplatin, and itraconazole or to compounds of similar chemical or biologic composition to itraconazole.
* Concurrent use of medications significantly affecting metabolism of itraconazole (certain anti-convulsants).
* Patients with hyperthyroidism (which would increase metabolism of itraconazole).
* Patients with grade ≥ 2 neuropathy.
* Patients with Uncontrolled, concurrent medical illness.
* Patients with active hepatitis or symptomatic liver disease.
* History of or current evidence of uncontrolled cardiac ventricular dysfunction (congestive heart failure) or patients with class III and class IV heart failure according to New York Heart Association (NYHA).
* Pregnant or lactating female .
Pharmacokinetics of Intravenous Difelikefalin in Chinese Adult Subjects on Haemodialysis

This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects. Treatment period is one week and there is a safety follow-up period of 1 week.

This is a Phase 1, single-arm, open-label study to evaluate the safety, PK, and tolerability of a repeated (3 times weekly) dose of difelikefalin administered as IV bolus injections to adult Chinese HD subjects.

Total study duration for a single subject is up to 5 weeks including a screening period of up to 3 weeks, a treatment period of 1 week, and a safety follow-up period of 1 week.

The duration of PK sampling is 12 days.

The primary objective of the study is to evaluate the PK profile of a repeated (3 times weekly) dose of difelikefalin in Chinese HD subjects over a 1-week treatment period.

Eligibility Criteria:
Inclusion Criteria:

* End-stage renal disease (ESRD) subjects who have been on HD for at least 3 months before enrolment in the study and are currently on HD 3 times per week.
* Subjects with a prescription dry body weight between 40 and 100 kg, inclusive.
* If female, is not pregnant, or nursing
* If female:

  1. Is surgically sterile; or
  2. Has been amenorrhoeic for at least 1 year and is over the age of 55 years; or
  3. Has a negative serum pregnancy test within 7 days before first dose of investigational product, and agrees to use adequate contraceptive precautions (e.g., hormonal contraceptives, barrier with spermicide, intrauterine device, vasectomised partner, or abstinence) from the time of informed consent until 7 days after the last dose of investigational product.
* If male, agrees not to donate sperm from the first dose of investigational product administration (Day 1) until 7 days after last dosing, and agrees to use a condom with spermicide or abstain from heterosexual intercourse during the study until 7 days after the last dose of investigational product.

Exclusion Criteria:

* Planned or anticipated to receive a kidney transplant during the study.
* Serum alanine aminotransferase (ALT), aspartate aminotransferase (AST) greater than 2.5 × the reference upper limit of normal (ULN), or bilirubin (total) greater than 4 × the ULN at screening.
* Subjects with severe hepatic impairment (Child-Pugh Class C).
* Known history of allergic reaction to opiates such as hives. Note: Side effects related to the use of opioids such as constipation or nausea would not exclude the subjects from the study.
* Subject has known hypersensitivity to the study intervention or any component of the investigational product formulation.
Efficacy of Motor Control Exercise Program After Lumbar Spinal Decompression Surgery

The study will be conducted with volunteer patients who have undergone lumbar decompression surgery and who are followed up by the Neurosurgery outpatient clinic of Fethiye State Hospital. The cases will be divided into 2 groups by randomization software. The control group will receive stretching, strengthening, core stabilization and educational content as usual care 3 months post-operatively. The study group will be given motion control exercises in addition to the program given to the control group 3 months post-operatively. These applications will be applied to the patients face-to-face in the clinical environment 2 days a week for 12 weeks. The first evaluation will be performed 3 months post-operatively before the treatment and the second evaluation will be performed 3 months after the treatment.


Eligibility Criteria:
Inclusion Criteria:

* To have undergone lumbar decompression surgery without fusion and 3 months have passed, to participate in all necessary follow-up evaluations and treatment sessions
* To be between the ages of 18-65, to be able to understand simple commands and to have signed the consent form

Exclusion Criteria:

* Presence of a previous spinal fusion surgery, presence of malignancy
* Having undergone spine surgery before
* Have any other orthopedic or neurological problem that may affect treatment and assessments
* Situations that may interfere with communication
* Lack of cooperation during the study and refusal to participate in the study