cyrilzakka/clinical-trials huggingface dataset:
Study of the Reversibility of Vigilance Dysfunction at 6 Months of Continuous Positive Airways Pressure (CPAP) in Patients With Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)

It is a monocentric prospective pilot study in Poitiers University Hospital, specifically analyzing the vigilance disorders in the Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and their reversibility after 6 months of Continuous positive airways pressure (CPAP).

All subjects were administered a test of vigilance (Test of Attentional Performance) both before and after the 6 months of CPAP.

The main objective is the study of the reversibility of alertness disorders on the number of omissions in the subtest visual vigilance of the TAP ( (Test of Attentional Performance) at 6 months of CPAP in the OSAHS in patients with a memory complaint.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-70 years
* Memory disorders without memory problems in episodic memory
* Presence of polysomnography of a obstructive sleep apnea/hypopnea syndrome (OSAHS) requiring Continuous positive airways pressure

  * Moderate OSAHS (Apnea Hypopnea Index ≥ 15 / hour with arousals ≥ 10)
  * Severe OSAHS (Apnea Hypopnea Index ≥ 30 / h)

Exclusion Criteria:

* Age \<20 years or ≥ 70 years
* Neurodegenerative disease (Alzheimer's disease, Parkinson's disease)
* Dysthyroidism
* Severe depression, schizophrenia, bipolar disorder
* Treatment with an effect on cognition: hypnotics, sedative
* Chronic Obstructive Pulmonary Disease
* Chronic alcoholism, other addictions
* Contraindications to Magnetic Resonance Imaging
* Refusal of equipment
RCT - Epidural Anesthetic Cocktail Following Endoscopic Lumbar Discectomy

The study aims to study the effect of intraoperative epidural application of anesthetic cocktail following endoscopic lumbar discectomy in improving postoperative pain, length of hospital stay, time at first dose analgesia, post-operative opioid consumption, functional outcomes, time return to work, and postoperative complications

This is a randomized controlled trial study the effects of epidural anesthetic cocktail. The cocktail, consists of triamcinolone 40 mg, marcaine 5 mg, and morphine 3 mg, is soaked in the gelfoam size 1x2 cm and applied on the epidura before removal of the endoscope. 54 participants are deivided into two arms, experimental and placebo group, and randomized into the trial. Primary objective is the ODI score from patient-reported function outcome at 3 months with secondary objective as mentioned above.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60
* Lumbar radiculopathy
* No prior spinal surgery or recurrent lumbar disc herniation
* Plan for endoscopic discectomy after failed conservative for at least 6 weeks
* Single-level herniation confirmed by MRI which correlated with symptoms

Exclusion Criteria:

* Allergic or contraindicated to amide-type anesthesia, opioid, NSAIDs, or steroids
* Cauda equina syndrome
* Concomitant with other abnormalities
* Unable to answer questionnaires
* Cannot tolerate surgery due to medical comorbidities
Quantitative MRI of Glenohumeral Cartilage & Labrum in Shoulder Instability

The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.

The purpose of this study is to assess cartilage strain and contact areas following glenohumeral instability compared to healthy individuals.

This is a prospective longitudinal cohort study to investigate cartilage strain and labral injury utilizing advance MRI techniques. Patients with shoulder instability will be studied at baseline (after injury and prior to surgical treatment) with glenohumeral cartilage strain MRI protocol, pre and post exercise. Patient reported outcomes including Western Ontario Shoulder Instability Index (WOSI), American Shoulder and Elbow Surgeon (ASES) Score, and PROMIS physical function and pain scores, will also be evaluated.

Data from this study will be compared to a previous study involving healthy controls that underwent the same exercises and imaging.

Eligibility Criteria:
Inclusion Criteria:

* Males and females ≥ 18 years old and ≤ 50 years old
* Acute injury involving anterior (front) shoulder dislocation
* Willingness to undergo arthroscopic shoulder stabilization
* Willingness to participant in standard rehabilitation

Exclusion Criteria:

* Moderate to severe osteoarthritis prior to surgery
* Will undergo bony augmentation to glenoid or humerus in addition to shoulder stabilization
* Unable to undergo standard pre and post-injury/operative rehabilitation
* History of inflammatory arthritis
* Previous surgery of the injured shoulder
A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).


Eligibility Criteria:
Inclusion Criteria:

* Are ambulatory.
* Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 Assessment of Spondyloarthritis International Society (ASAS) classification criteria.
* Have a history of back pain ≥3 months with age at onset \<45 years.
* Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating scale (NRS) at screening and baseline.
* Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated C-reactive protein (CRP).
* In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
* If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.
* Have a history of prior therapy for axSpA for at least 12 weeks prior to screening.

Exclusion Criteria:

* Have radiographic sacroiliitis fulfilling the 1984 modified New York criteria.
* Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
* Have received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
* Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.
* Have a compromised immune system.
* Have any other serious and/or uncontrolled diseases.
* Have either a current diagnosis or a recent history of malignant disease.
* Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
* Are pregnant or breastfeeding.
* Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.
Private Medicine Retailer-based Trial of Malaria Tests and Conditional Treatment Subsidies Among Patients With Fever

The goal of this study observational study is to test the effect of conditional subsidies for Rapid Diagnostic Tests (RDT) and Artemisinin Combination Therapies (ACT) on improving the management of malaria fevers that seek care in the retail sector. The main question it aims to answer is:

• Would a conditional subsidy scheme increase the proportion of clients with malaria receiving an ACT? Researchers will compare the proportion of patients with malaria receiving an ACT in the intervention arms to the control arm. Retail providers in the intervention arm have access to free RDTs and subsidized ACTs distributed by the research team and are asked to use a recommended retail price for the RDT and ACT. In addition, the providers in the intervention arm are trained in the use of RDTs and a mobile app that will prompt them to take and upload a picture of the RDT result. Retail providers in the control arm are trained in the use of RDTs but do not receive free RDTs or subsidized ACTs.

The ultimate goal of the conditional subsidy scheme is to increase the proportion of patients with malaria that receives an artemisinin combination therapy (ACT) at the point of sale.

The objective of this study is to test the effect of providing low-cost malaria rapid diagnostic tests (RDT) and Artemisinin Combination Therapies (ACTs) to patients on improving the management of malaria fevers that receive care in private medicine retailers (PMR). During the study, malaria RDTs are provided free of charge to the private provider to conduct malaria-RDT testing at a low cost (at a set recommended retail price) for patients with a malaria-like illness. Subsidized ACTs are provided to the provider, conditional on the provider conducting the malaria RDT and selling the ACT at a low cost to patients testing positive for malaria. Outcomes will be measured by exit interviews on random days each month at participating PMRs.

Eligibility Criteria:
Inclusion Criteria:

* Participants who tested in the Private Medicine Retailer and/or purchased antimalarial (s) for themselves.
* Individuals with malaria-like illness must be present at recruitment.
* Older than one year of age.

Exclusion Criteria:

* Any individual with signs of severe illness requiring immediate referral.
* Individuals who have taken an antimalarial in the last seven days, including for the current illness.
* Patients \<18 years without a parent or legal guardian present.
* Adults who are unable to consent for themselves
Adherence in Patients Receiving PegIntron Pen/Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04281)(COMPLETED)

Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron pen and Rebetol according to label and the patient assistance program. This study will be compared to similar studies from other clinics using various patient support programs for the purpose of designing future comparative phase IV studies.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with hepatitis C

Exclusion Criteria:

* According to the products' labeling (refer to Warnings, contraindications, and safety sections).
Effects of Ai Chi on Scapular Muscle Activation in Overhead Athletes With Scapular Dyskinesis

Scapular dyskinesis (SD) is common in overhead athletes and negatively influence the athletes' performance, increasing the risk of shoulder injury. The kinetic chain (KC) exercises for SD rehabilitation that emphasize importance of core strength and scapula stability during skillful performance. Ai Chi, the aquatic exercises performed in functional positions, which are adequate for power transfer of KC. This study will investigate the effect of KC-based water exercises, Ai Chi, on scapular muscles in overhead athletes with SD.

The purpose of this study is to investigate muscle activations of the upper trapezius (UT), lower trapezius (LT), serratus anterior (SA), latissimus dorsi (LD), and muscle balance ratios of UT/LT, UT/SA I in overhead athletes with SD via KC-based exercise in water and on land. KC-based exercises including the movement patterns of Ai Chi which consist of shoulder flexion/ extension, horizontal abduction/ adduction, internal and external rotation, scapular protraction/retraction combined with spinal rotation.

Eligibility Criteria:
Inclusion Criteria:

* The participants are overhead athletes with scapular dyskinesis (SD) who played overhead sports activities at least 3 hours/week.

Exclusion Criteria:

* the individuals who have shoulder/neck pain in recent 3 months (VAS \>7/10)
* severe shoulder trauma (the collision shoulder, shoulder sprains or strains)
* severe scoliosis (Cobb angle \> 25 degrees)
* surgery of upper extremity (the shoulder, cervical spine and elbow) or cervical spine
* peripheral nerve injury or neurological disease (impaired sensation or motor function: numbness, tingle, muscle weakness)
* body mass index (BMI) \>25
* infectious disease (upper respiratory tract infection, skin infection, etc.)
Verification of Imaging System PCD-1000A

Scope Verification of technologies included in the PCD-1000A PET/CT imaging chain.

* Define and confirm all supported clinical protocols
* Evaluate performance

The study aim is system verification and associated software. Clinical data and clinical feedback will be used for verification.

Eligibility Criteria:
Inclusion Criteria:

* Patients already scheduled for an FDG test at SDMI
* 40 years and older
* Capable of providing their informed consent

Exclusion Criteria:

* Patients not scheduled for an FDG test at SDMI
* 39 years or younger
* Adult female patients that are and/or could become pregnant
* Not capable of providing their informed consent
Chronic Versus Intermittent Deep Brain Stimulation for Essential Tremor

The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation.

The proposed study is a randomized, single blind trial of intermittent versus continuous stimulation among essential tremor (ET) patients with a chronic history of continuous stimulation. The trial is 10 weeks in length with clinical evaluations (about 60 minutes) performed on weeks 1, 2, 6, and 10, and phone interviews (about 5 minutes) on weeks 3, 4, 5, 7, 8, and 9. The study includes outcome measures of tremor, stimulation-induced side effects, sleep quality, and voltage threshold for optimal tremor control and sustained side-effects.

Eligibility Criteria:
Inclusion Criteria:

* individuals with essential tremor who are at least 6 months status-post thalamic stimulator placement
* maintained a consistent chronic or intermittent stimulation schedule for at least 4 consecutive weeks prior to study enrollment
* no changes in stimulation parameters for at least 2 consecutive months prior to study enrollment

Exclusion Criteria:

* patients with clinically significant dementia (i.e., a score less than 24 out of 30 on the Mini Mental Status Exam14)
* women who are not post-menopausal
* patients with other significant neurological or psychiatric disease other than essential tremor
* patients treated with pallidotomy or thalamotomy
* patients with significant psychiatric disturbance as determined by Diagnostic and Statistical Manual-IV criteria which would make informed consent/cooperation problematic
Efficacy of Tiotropium in Patients of African Descent With Chronic Obstructive Pulmonary Disease

The purpose of this study is to look at the benefits of tiotropium, an approved drug for the treatment of bronchospasm associated with COPD (chronic obstructive pulmonary disease), in a population of patients with COPD who are of African American descent.


Eligibility Criteria:
Inclusion Criteria:

* Male or female of African descent
* 40 years of age or older
* Diagnosis of COPD
* History of smoking at least one pack per day for at least 10 years
* Currently experiencing shortness of breath at least with exertion

Exclusion Criteria:

* Asthma
* Recent myocardial infarction or hospitalization for congestive heart failure
Calcium Electroporation for the Treatment of Colorectal Cancer

In this phase I study 6 patients with inoperable colorectal cancer is treated with calcium electroporation to establish safety and efficacy of the treatment.

A total of 6 evaluable patients with inoperable colorectal cancer are expected to be included in the study and the time for inclusion of patients is estimated to be 1-2 years. All patients will have been offered the standard of care and all available alternatives before entering the protocol. Calcium electroporation will not be compared to other means of treatment.

All patients will be treated once, but in case of residual tumor tissue at follow-up, and if the investigator considers it safe, they will be offered re-treatment. A maximum of 3 treatments per patient will be conducted with an interval of minimum 4 weeks. The patients will be followed with regular examinations for 12 months, starting from first treatment day.

Eligibility Criteria:
Inclusion Criteria:

* Histologically verified colorectal tumor
* Conferred by multidisciplinary team (radiologists, surgeons and oncologists) discussing options possible for the patient, resulting in agreement that an endoscopic treatment with calcium electroporation should be offered to the patient.
* Treatment free interval of minimum 2 weeks.
* Thrombocytes ≥ 50 billions/l, INR \>1,2. Medical correction is allowed, e.g. correction of elevated INR by means of vitamin K.
* Performance status ECOG/WHO ≤2
* Both men and women who are sexually active must use safe contraception (contraceptive coil, deposit injection of gestagen, subdermal implantation, hormonal vaginal ring or transdermal patch.)
* Trial subject ≥ 18 years.
* Trial subject must be able to understand the participants' information.
* Signed informed consent. The patients are considered participants in the study after signing of the informed consent.

Exclusion criteria:

* Coagulative disturbance that cannot be corrected
* Pregnancy or lactation (Pregnancy is ruled out in fertile women by an HCG test in a blood sample)
* Concurrent participation in other clinical trials that involve experimental drugs or participation in a clinical trial involving experimental drugs within 4 weeks prior to administration of the drug in this study.
* Treatment with bevacizumab within the last 4 weeks.
* Heavily inflamed colorectal mucus membrane with bleeding or ulcerations.
* Implanted colon stent
* Other clinical disease or previous treatments that make the investigator deem the patient unfit.
Administration of Methylprednisolone for Prevention of Ovarian Hyper Stimulation Syndrome

This study is a prospective randomized clinical controlled trial to assess the efficacy of the Methylprednisolone for preventing ovarian hyper stimulation syndrome in in vitro fertilization (IVF) cycles.

Ovarian hyper stimulation syndrome is the most serious complication of ovarian stimulation which might be life threatening in the severe forms. Since there is still no definite cure for this syndrome, prevention is considered as an essential and vital issue. The objective of this study is to determine the effect of Methylprednisolone to prevent ovarian hyper stimulation syndrome in IVF cycles.

The study population comprises all infertile patients with diagnosis of polycystic ovarian syndrome which will undergo of in-vitro fertilization. The PCO subjects will be recognized based on the Rotterdam criteria inclusive the presence of least 2 signs of oligomenorrhea, hyper androgynism (clinical or laboratory), LH/FSH\>2 and ovarian morphological evidences in Doppler ultrasound.

The existence of more than 20 follicles in both ovaries and E2 concentration \>4000 pg/ml will be considered as the OHSS risk factors.

In this study all eligible patients will be randomly allocated into two study groups by a computerized randomization method:

Treatment group (case) will be administered 16 mg Methylprednisolone initiated from the first day of stimulation and will be tapered after the first pregnancy test (day 13 after the embryo transfer). Furthermore, these patients will receive a bolus IV dose methylprednisolone, 1g on the day of egg collection and embryo transfer.

Patients in the control group will not receive any treatment with glucocorticoids. If each group confronts with every kind of high risk signs or symptoms, they will undergo coasting or gonadotropin withdrawal or other treatment strategies.

The presence of OHSS is defined in accordance with the Golan 5 grade system and women who at least are at grade 2 of this classification (Mild) considered as OHSS cases and will experience abdominal distention and discomfort, nausea and vomiting and/or diarrhea and enlargement of ovaries(5-12cm). In Moderate forms, ultrasound evidences of ascites will be observed and severe OHSS accompany with clinical signs of ascites, hydrothorax, breathing disorders, hemoconcentration, coagulopathy and renal perfusion decrease.

Eligibility Criteria:
Inclusion Criteria:

* Poly Cystic Ovarian Syndrome patients
* Indication for IVF/ICSI and Long Protocol ovarian stimulation
* Basal FSH≥10
* Normal BMI (20-25)
* physical health

Exclusion Criteria:

* Allergy to GnRH analogues, FSH and corticosteroids
* presence of heart failure, recent myocardial infarction
* Hypertension
* Diabetes mellitus
* epilepsy
* glaucoma
* hypothyroidism
* hepatic failure
* osteoporosis
* peptic ulceration
* renal impairment
* Using drugs that have interaction with corticosteroids such
Irradiation-based Myeloablative Conditioning Followed by Treg/Tcon Immunotherapy in HSCT

To evaluate if hyper-fractionated TBI or TMLI followed by Treg/Tcon adoptive immunotherapy improve cGvHD/disease free survival after allogeneic HSCT in patients affected by high-risk acute leukemias or other hematologic malignancy where HSCT is indicated.

Improving cGvHD/disease free survival in patients with high-risk acute leukemias or other hematologic malignancy where HSCT is indicated with the use of a regulatory T cell based protocol. Hyper-fractionated Total Body Irradiation or Total Marrow and Lymphoid Irradiation based conditioning will be followed by the infusion of T regulatory and T conventional cell adoptive immunotherapy and a purified CD34+ hematopoietic stem cell graft. Incidence of Non Relapse Mortality, Relapse, acute Graft versus Host Disease, chronic Graft versus Host Disease, as well as probability of cGvHD/disease free survival will be assessed in patient subpopulations separated according to HLA-matching with the donor (HLA-matched HSCT and HLA-haploidentical HSCT) and type of disease (acute myeloid leukemia, acute lymphoid leukemia, lymphoma, multiple myeloma, myeloproliferative disease, and other).

Eligibility Criteria:
Inclusion Criteria:

* AML and ALL in complete remission and with high-risk of relapse
* AML and ALL primarily chemoresistant or relapsed;
* Chronic Myeloid Leukemia in accelerated or blastic phase;
* Patients affected by

  * Multiple myeloma,
  * Non Hodgkin lymphoma,
  * Hodgkin lymphoma,
  * Chronic myeloproliferative syndrome,
  * Chronic Lymphoid Leukemia,
  * Other Hematological malignancy at high-risk of relapse or detectable disease and where a HSCT is indicated.
* Age \<75 years
* ECOG ≤ 2
* Acceptable lung, liver, kidney, and heart function and absence of relevant psichiatric diseases
* Signature of the informed consent

Exclusion Criteria:

* Age \>75 years
* ECOG \> 2
* Not acceptable lung, liver, kidney, and heart function and presence of relevant psichiatric diseases
* Pregnancy
* No signature of the informed consent