cyrilzakka/clinical-trials huggingface dataset:
rTMS and Rehabilitation for Individuals With CRPS Type 1

Subjects with complex regional pain syndrome (CRPS) Type 1 will be randomized to receive repeated transcranial magnetic stimulation (rTMS) followed by rehabilitation or sham rTMS followed by rehabilitation. Treatment will last for 4 weeks, with the first week including 4 rTMS treatments and 2 rehabilitation treatments. Subsequent weeks will include 2 rTMS treatments followed by 2 rehabilitation treatments. Outcome measures will include pain ratings, PROMIS questionnaires, global rating of change, and grip strength or 1 repetition maximum leg press.

Subjects will be randomized to receive either real or sham rTMS, combined with rehabilitation. Subjects will attend 10 sessions over 4 weeks.

rTMS will be delivered at 10Hz using an intensity of 80% of the motor threshold. Pulse trains will be delivered for 10 seconds, with a 30-second rest for 20 repetitions. This will result in a total of 2,000 pulses of magnetic stimulation and will take approximately 20 minutes. There will be 10 rTMS sessions over the 4 weeks.

Sham rTMS will be delivered using the same method as rTMS, but a sham coil, that does not deliver magnetic stimulation, will be used.

Rehabilitation will include graded motor imagery, education, and graded functional activity. There will be 8 rehabilitation sessions over 4 weeks.

Outcomes will include questionnaires asking about pain and function, and either grip strength or leg press strength measurements.

Eligibility Criteria:
Inclusion Criteria:

* Upper or lower extremity CRPS Type 1 (also called RSD-Reflex Sympathetic Dystrophy) of at least 6 months.
* Pain rating on NPRS of at least 4/10
* No initiation of a new intervention (i.e., medication, rehab, injections) in the previous 2 months.
* No plan to initiate a new intervention during the study treatment timeframe (4 weeks).

Exclusion Criteria:

* A history of seizures or epilepsy
* Intracranial metallic devices
* Pacemaker
* Intrathecal infusion pumps
* Brain or spinal cord stimulators with epidural electrodes
* Other ferromagnetic metallic intracranial implants
* Apparent mental or psychiatric disorder that prevents adequate informed consent
* Current pregnancy
* Non-English speaking
A Study of Molidustat for Maintenance Treatment of Renal Anemia in Non-dialysis Subjects

The purpose of this study is to evaluate the efficacy and safety of molidustat in non-dialysis subjects previously treated with Erythropoiesis-Stimulating Agents (ESAs)


Eligibility Criteria:
Inclusion Criteria:

* Subjects with estimated glomerular filtration rate (eGFR)\< 60 mL/min/1.73m\^2 (Chronic kidney disease \[CKD\] stages 3 to 5)
* Have used the same ESA for 8 weeks prior to screening
* Treated with darbepoetin alfa with bi-weekly or monthly dose, epoetin beta pegol with monthly, OR epoetin alfa/beta weekly or bi-weekly, and having had no more than one dose change within 8 weeks prior to randomization
* Body weight \> 40 and ≤ 160 kg at screening
* Male or female subject ≥ 20 years of age at screening
* Not on dialysis and not expected to start dialysis during the study period
* Mean screening Hb level ≥ 10.0 and \< 13.0 g/dL (mean of all central laboratory Hb levels \[at least 2 measurements must be taken ≥ 2 days apart\] during the 8-week screening period, AND all Hb level must be measured by the central laboratory, AND the difference between the lowest level and highest level is \< 1.2 g/dL), with the last screening Hb level measurement within 14 days prior to randomization
* Ferritin ≥ 100 ng/mL or Transferrin saturation ≥ 20%

Exclusion Criteria:

* New York Heart Association (NYHA) Class III or IV congestive heart failure
* History of cardio- (cerebro-) vascular events (e.g., unstable angina, myocardial infarction, stroke, pulmonary thromboembolism, and acute limb ischemia) within 6 months prior to randomization
* Sustained and poorly controlled arterial hypertension (defined as systolic BP (blood pressure)≥ 180mmHg or diastolic BP ≥ 110mmHg) or hypotension (defined as systolic BP \< 90mmHg) at randomization
* Proliferative choroidal or retinal disease, such as neovascular age-related macular degeneration or proliferative diabetic retinopathy requiring invasive treatment (e.g., intraocular injections or laser photocoagulation)
Multi-dose Vitamin D Supplementation in Preterm Infants

Preterm newborns are born with lower vitamin D stores. Although vitamin D supplementation is recommended there is no consensus regarding the adequate dose of supplementation for preterm infants.

Vitamin D is a fat-soluble vitamin that is either taken by dietary sources or synthesized upon exposure to sun light. Although major function is on bone metabolism, in recent years other effects of Vitamin D attracted attention. Low neonatal vitamin D levels were reported to be associated with increased risk of respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD) and sepsis.

Vitamin D level in the fetus and the newborn is mostly dependent on maternal vitamin D levels. Most of the vitamin D is transferred to the fetus during third trimester and as a result preterm newborns especially those with \<32 weeks gestational age are born with lower vitamin D stores. But there is no consensus regarding the adequate dose of vitamin D supplementation for preterm infants. The American Academy of Pediatrics recommends supplementation of 200-400 IU/d vitamin D for preterm infants. And the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) recommends 800-1000 IU/d vitamin D supplementation for preterm infants.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants with gestational age 24 to 32 weeks who achieved at least 75% of total nutrition by enteral feedings in postnatal 2 weeks

Exclusion Criteria:

* perinatal asphyxia,
* major congenital or chromosomal anomalies,
* those with no expectation of survival in first 2 weeks
* those that total parenteral nutrition was not ceased by the first 2 weeks
Therapeutic Alliances in Alcoholism Treatment

This project is studying the role of the therapeutic alliance between the therapist and patient in the outpatient treatment of persons with alcohol use disorders.

This project is studying the role of the therapeutic alliance between the therapist and patient in the outpatient treatment of persons with alcohol use disorders. Alliances are assessed over the course of treatment and will be reviewed in the context of posttreatment functioning.

Eligibility Criteria:
Inclusion Criteria:

* Current Alcohol Dependence diagnosis
* Live within commuting distance of treatment program
* Minimum 6th grade reading level
* Provide consent

Exclusion Criteria:

* Presence of current organic mental disorder, schizophrenia, or another psychotic disorder
* Treatment for an alcohol use disorder in past 12 months
Pain Patch Versus Injections in the Treatment of Pain Associated With Shoulder Impingement Syndrome

Objective:

This purpose of this pilot study is to explore the potential usefulness of Synera for the treatment of pain associated with shoulder impingement syndrome.

Subjects will receive either a subacromial injection at baseline or will be issued Synera patches to use daily for 2 weeks and then PRN for an additional 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age.
* have pain associated with shoulder impingement syndrome in a single shoulder (minimum 2-week duration).
* have tenderness at the attachment site of the rotator cuff tendons.
* have positive Hawkin's and Neer's signs.
* report an average pain intensity score of 4 (on an 11-point scale) over the past 24 hours at the Screening/Baseline visit.

Exclusion Criteria:

* have used any topically applied pain medication on the target treatment area within 14 days preceding Study Day 1, such as non-steroidal anti-inflammatory drugs (NSAIDs), menthol, methyl salicylate, local anesthetics (including Lidoderm®), or steroids.
* have used any injected medication within 60 days preceding Study Day 1, such as local anesthetic (lidocaine) or steroids.
* have a clinically significant illness within 14 days of Screening/Day 1 that, in the opinion of the investigator, would preclude the subject from participating in the study.
* are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)
* have a history of and/or past diagnosis of severe hepatic disease.
* have participated in a clinical trial of an unapproved drug within 30 days prior to screening.
* are pregnant, breastfeeding, or a female of childbearing potential and not practicing an acceptable method of birth control.
* are unable or unwilling, in the opinion of the investigators, to comply with all study procedures and cooperate fully with research staff.
* have filed a disability claim or are currently receiving disability payments for shoulder impingement syndrome.
Effect of Food on the Pharmacokinetics of AQW051 in Japanese Healthy Male Subjects

This study will evaluate safety, tolerability and pharmacokinetics of individual oral doses of AQW051 in Japanese healthy male subjects, and will also evaluate the effect of food on the pharmacokinetics of AQW051.


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy male subjects age 20 to 45 years of age, and in good health
* At screening and baseline, the subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis.
* Body mass index within the range of 17 to 25 kg/m2 and weigh at least 50 kg

Exclusion Criteria:

* Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening for all subjects. Smokers will be defined as any subject who reports tobacco use or has a urine cotinine 'high' level in checking by NicCheck® I.
* Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Acetaminophen is acceptable.
* Participation in any clinical investigation within 4 months prior to study start.
* Donation or loss of 400 mL or more of blood within 3 months; donation or loss of 200 mL or more of blood within 1 month; or donation of component blood within 2 weeks prior to study start.
* Subjects considered unsuitable for participation in the study within 2 weeks prior to dosing.
* A past medical history of clinically significant abnormality detected during electrocardiogram (ECG) examination or an evident family history (grandparents, parents and siblings) of a ECG abnormality (i.e. prolonged QT-interval syndrome).
* History of fainting, hypotension when standing up, arrhythmia.
* History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* History of clinically significant drug allergy, history or presence of atopic allergy (asthma, urticaria, eczematous dermatitis) unless inactive seasonal allergy, or history of food allergy. A known hypersensitivity to the study drug or drugs similar to the study drug.
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize the subject in case of participation in the study.
* History of immunodeficiency diseases, including a positive HIV test result.
* A positive Hepatitis B surface antigen (HBsAg), Hepatitis C or Syphilis test result.
* History of drug or alcohol abuse within the 12 months prior to study participation or evidence of such abuse as indicated by the laboratory assays conducted at screening.

Other protocol-defined inclusion/exclusion criteria may apply
Carmustine Plus O(6)-Benzylguanine in Treating Patients With Recurrent or Progressive Gliomas of the Brain

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of carmustine plus O(6)-benzylguanine in treating patients who have recurrent or progressive gliomas of the brain.

OBJECTIVES: I. Determine the maximum tolerated dose of carmustine when administered following O6-benzylguanine in patients with recurrent, persistent, or progressive cerebral anaplastic gliomas. II. Characterize the toxic effects associated with this treatment regimen in these patients. III. Observe patients for clinical antitumor response when treated with this regimen.

OUTLINE: Patients are stratified according to prior nitrosourea administration (yes or no). (Prior nitrosoureas stratum closed) An initial cohort of 3 patients per stratum is treated with intravenous O6-benzylguanine followed approximately 1 hour later by intravenous carmustine every 6 weeks. Additional cohorts of 3-6 patients are treated with escalating doses of carmustine until dose limiting toxicity (DLT) is observed. The maximum tolerated dose is defined as the dose at which no more than 1 of 6 patients experiences DLT. Courses are repeated every 6 weeks in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 24-56 patients (12-28 per stratum) will be accrued in 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven recurrent, persistent, or progressive glioblastoma multiforme or anaplastic astrocytoma diagnosed by biopsy/resection Evaluable residual disease by MRI or CT scan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT no greater than 2.5 times upper limit of normal Bilirubin within normal limits Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min BUN no greater than 25 mg/dL Pulmonary: DLCO greater than 80% predicted Other: Not pregnant or nursing Fertile patients must use effective contraceptive method during and for 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosourea, procarbazine, or mitomycin) and recovered Endocrine therapy: Concurrent corticosteroid therapy must be stable for at least 1 week prior to study, if clinically possible Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified
Intrathecal Additives for Spinal Anaesthesia in Elective Caesarean Sections

we designed this randomized, single -blind, prospective clinical study to test postoperative analgesia of three intrathecal additives in elective caesarean sections which are magnesium, dexamethasone and dexmedetomidine.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists classII-III adult female patient (age :18 -40 years old )
* Elective cesarean section under spinal anaesthesia
* Gestational age \> 37 weeks
* BMI less than 30 kg/m2

Exclusion Criteria:

* Patient refusal
* unable to give consent
* age \< 18 or \> 40
* BMI more than 30 kg/m2
* known allergy to the study medication
* coagulopathies or on anticoagulant medications
* diabetic neuropathy
* patients with psychiatric disorders
A Phase I Study to Assess the Safety and Distribution of VB-111 in Patients With Advanced Metastatic Cancer

Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in Patients with Advanced Metastatic Cancer

Nine Cohorts of dose escalating VB-111 were completed with a total of 56 subjects enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age
* Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. For Cohort 8, malignancy will include only NET or RCC.
* Karnofsky performance status of ≥70%
* Patients with an adequate hematological profile
* Patients with an adequate renal function
* Males and Females of childbearing potential must utilize a standard contraception method
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Patients, who suffered from an acute cardiac event within the last 12 months
* Patients with active vascular disease, either myocardial or peripheral
* Patients with proliferative and/or vascular retinopathy
* Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune)
* Patients with known CNS metastatic disease
* Patients testing positive to one of the following viruses: HIV, HBV or HCV
* Patients receiving chemotherapy or radiotherapy within the last 4 weeks before enrolment
* Patients that have undergone major surgery within the last 4 weeks before enrolment
* Patients may not have received anti-angiogenic therapy within the previous 8 weeks before enrolment.
* Patients may not have received any other investigational agent within 4 weeks before enrolment.
* Patients with an ongoing requirement for an immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before enrolment
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Use of Cognitive Stimulation Software for Patients Over the Age of 70 Followed for Breast Cancer: COG-TAB-AGE Feasibility Study

Numerous studies have shown the impact of anti-cancer treatments on cognition and more particularly that of chemotherapy. Elderly patients also seem to be at higher risk of developing cognitive impairment. These disorders can have a particularly negative impact in this population, in particular by having repercussions on the observance of oral treatments or even on autonomy. However, investigators still have little data concerning the management of cognitive disorders induced by oncology treatments, particularly in the elderly patient. It is therefore necessary to offer care adapted to this population which will allow the reduction of the sequelae induced by cancer treatments and the improvement of the quality of life of elderly patients.Although there are no preventive measures yet, recent studies of young women being treated for breast cancer with a cognitive complaint have shown a beneficial effect of cognitive stimulation on these cognitive disorders. Stimulation programs of this type have been developed in electronic format. However, to date, they have not been the subject of specific studies with elderly patients in whom the use of computer interface can be an obstacle.Sponsor propose to set up a study aimed at evaluating the feasibility of using cognitive stimulation software on tablets with elderly patients.The HAPPYNeuron® software, developed by a French team of neurologists, speech-language pathologists and psychiatrists, offers exercises to be performed online to stimulate the cognitive functions most impaired by oncological treatments (memory, attention, executive functions and speed of treatment).For this feasibility study, the sponsor plan to include 50 patients aged 70 and over to have them test the acceptance of cognitive stimulation by this software with a tablet interface.


Eligibility Criteria:
Inclusion Criteria:

* Patient with breast cancer, aged 70 and over,
* During treatment with chemotherapy, targeted therapy or radiotherapy.
* Whatever the stage of the disease,
* Hospitalised in a week hospital, in traditional hospitalisation for an intercurrent episode or day hospitalisation, or undergoing radiotherapy
* Absence of major cognitive impairment preventing cognitive tests (compliance with the MoCA score threshold based on the patient's age and educational level according to GRECOGVASC standards),
* Patient with education level 3 "end of primary education" minimum (Barbizet scale),
* Mastery of the French language,
* Patient who signed the consent to participate in the study.

Exclusion Criteria:

* Hospitalization for neurological reasons (e.g. confusion), or psychiatric,
* Documented brain metastases,
* History of brain radiation therapy,
* Progressive psychiatric pathology or known dementia,
* Abuse of alcohol or drug use,
* Severe visual and / or hearing loss,
* Patient's refusal to participate,
* Patient deprived of liberty or under guardianship.
Laryngeal Mask in Upper Gastrointestinal Procedures

Diagnostic and operative procedures of upper gastrointestinal (GI) tract are very common in all patients. Some procedures are difficult to tolerate because of long duration, prone position or significant stimulation of the upper airways. An example are endoscopic retrograde cholangiopancreatography (ERCP) and endoscopic pancreatic ultrasound.

The procedures are generally performed with deep sedation. Many pharmacologic regimens are available and described in literature. The investigator's institute adopts propofol target controlled infusion (TCI), which usually guarantees unconsciousness and unresponsiveness of patients. The main adverse event is dose-related respiratory depression. Pre-existing reasons for hypoventilation can exacerbate this event, especially in the elderly and the chronic obstructive pulmonary disease-patients. Laryngeal mask (LMA) is a useful tool to apply a pressure support ventilation. One specific type of LMA allows to separate the gastric and respiratory tract and, allows the anesthesiologist to support patient's ventilation as (and only if) necessary.

This is a monocentric randomized controlled trial of superiority of LMA use in GI endoscopic procedures. Randomization is centralized. The study is single blind (patient). The study is no-profit. Every patients undergoing scheduled ERCP and endoscopic ultrasound will be screened and consecutive eligible patients will be enrolled. Subjects will be allocated according to a simple randomization list. The study starts after randomization and ends after discharge from the recovery room. After peripheral venous catheter insertion and vital parameters monitoring, patients will receive propofol TCI with a tailored target between 4 and 6 mcg/ml. The treatment group will receive LMA insertion and End-Tidal Carbon Dioxide (ETCO2) monitoring throughout the procedure. In case of hypoventilation, with an ETCO2 above 50 mmHg, the patient will be supported as necessary with PSV. The control group will not receive any airway device, according to the standard treatment. At the end of the procedure, both group will receive a laboratory testing (peripheral arterial sample), when the patient is still sedated. Vital parameters monitoring will continue in recovery room. Patients will be discharge as usual with an Aldrete score \> 9.

Data will be collected during the procedure and in recovery room. Data will be stored in electronic database without mention to patient's name.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* written informed consent
* elective ERCP and endoscopic ultrasound procedure

Exclusion Criteria:

* pregnancy
* contraindication to propofol administration
* contraindication to mask insertion (e.g. malformation)
* emergency operation (not scheduled)
* preexisting causes of hypoventilation (e.g. chronic obstructive pulmonary disease, neuromuscular disease...)