cyrilzakka/clinical-trials huggingface dataset:
Double Blind Randomized, Monocentric, Cross-over, Placebo-controlled Study to Evaluate the Effect of Citalopram on Motivation

The aim of the current study is to examine the role of serotonin on the cognitive parameters of motivation. They are embedded in a conceptual framework of motivation that merges decision-making and reinforcement learning theories. Every action is conceived as path from one state to another. The different states are associated to different values (positive for rewards and negative for punishments), and the different actions to different costs (risk, effort and delay). The tasks are designed such that the sensitivity to the state and action parameters can be inferred by fitting computational models.The primary objective is to characterize the effect of Citalopram 30mg on reward sensitivity, assessed in an incentive force task, in which participants are asked to squeeze a hand grip to win monetary rewards. Secondary objectives are to characterize the effect of Citalopram 30mg on other cognitive parameters of motivation (assessed with a motivational battery that includes rating, choice and learning tasks).


Eligibility Criteria:
Inclusion Criteria:

* Man or woman, age ≥ 18 and \< 50
* Weight between 50 kg and 90 kg.
* No contraindication to effort
* No evolutive pathology that could interfere with the current study signed consent
* medical insurance ("sécurité sociale")

Exclusion Criteria:

* Age \< 18 or \> 50
* Smokers
* Person under curatorship, or guardianship, or with civil rights deprivation
* History of neurologic or psychiatric pathology
* Presence of any psychotropic treatment
* Chronic or actual consumption of alcohol, or psychotropic drugs
* pregnancy, breastfeeding
* Woman of childbearing potential without effective contraception
* Hypersensitivity to atomoxetine or other constituents of the product
* Pheochromocytoma
* Narrow angle Glaucoma
* Liver failure
* Severe Cardiovascular Disorders
* Severe Cerebrovascular Discorders
* Treatment with non-selective Monoamine Oxidase Inhibitor (MAOI) : iproniazide.
* Treatment with Linezoline, Lithium, Milleperthuis, Tramadol, tryptans.
* Treatment with Pimozide, or treatment that can induce a QT prolongation (neuroleptics, class IA and III antiarrythmic, moxifloxacine, erythromicine, methadone, mefloquine, tricyclic antidepressants, lithium, cisapride), or treatment that can induce an hydroelectrolytic inbalance (thiazide diuretics).
* Treatment with Anticoagulants
* Treatment that can decrease seizure threshold: antidepressants, neuroleptics, mefloquine, buproprione, tramadol
* Enzyme inducers, (rifampicine, ...)
* Treatment that can interfere with the performance of the subject: beta2 adrenergic agonists, analgesics, corticosteroïds, anti-inflammatory drugs, ...
Immediate Effects of Kinesio Taping Applied to the Thoracic Region in Adult Individuals

The purpose of the study is to search immediate effects of kinesio taping applied to the thoracic region on proprioception, posture and trunk muscle endurance in adult individuals.

Kinesio tape applications are one of the frequently used interventions within the scope of physiotherapy and rehabilitation. Kinesio taping is a non-invasive treatment method performed for several reasons such as reducing pain, relieving abnormal muscle and fascia tension and correcting biomechanical alignment. Kinesio taping consists of muscle, fascia, ligament, mechanic, functional and lymphatic correction techniques depending on therapeutic purposes.

Although kinesio tape applications on different regions such as abdomen or neck may have positive effects on posture, proprioception and trunk muscle endurance, there has not been found any study searching the effectiveness of kinesio taping applied to thoracal region on posture, proprioception and trunk muscle endurance in adult individuals. Thus, there is a need to investigate this issue.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 35 years,
* Volunteer to paticipate to the study

Exclusion Criteria:

* Musculoskeletal pain problems in the last 6 months
* Spinal fractures
* History related to spinal surgery
* Spinal deformity (scoliosis etc)
* Any chronic disease (cancer, diabetes mellitus, hypertension etc. )
* Body mass index\>35 kg/m2
* Mental or psychologic problems
* Any dermatologic disease
* Allergy to kinesio tape
Fluid Filled Lung Oxygenation Assistance Trial

The primary study objective is to assess the safety and feasibility of perfluorooctylbromide (PFOB) partial liquid ventilation (PLV) in infants with severe Bronchopulmonary Dysplasia (BPD).

The primary study objective is to assess the safety and feasibility of perfluorooctylbromide (PFOB) partial liquid ventilation for up to ten days in infants with severe BPD as evaluated by: (1) no sustained oxygen desaturations (SpO2 ≤ 80%) for greater than ten minutes without response to increased oxygen therapy, (2) no persistent hypotension without response to volume expansion and/or inotropic therapy, (3) no major mucus plugging events (defined as events that are unresolved after two bronchoscopes), (4) no pneumothoraces or pleural effusion with PFOB, (5) and no evidence of increased carbon dioxide (CO2) retention, renal insufficiency, hyperkalemia, or metabolic acidosis.

Eligibility Criteria:
Inclusion Criteria

1. Neonates with severe BPD as defined by 36 weeks post conception age and require positive pressure ventilation
2. Infants born at less than 32 weeks post conception age
3. Subjects may be up to 6 months corrected age
4. On conventional mechanical ventilation for chronic lung disease for at least two days prior to enrollment
5. On conventional mechanical ventilation at the time of enrollment and anticipated to continue for 14 days
6. Off systemic steroids for lung disease for 72 hours (3 days) prior to T=0
7. Hemoglobin value ≥8 g/dL: if less than 8 g/dL, transfusion is permitted. Clinical blood transfusion should be administered prior to enrollment.
8. Parental/guardian permission (informed consent)

Exclusion Criteria

1. Mechanical ventilation for acute disease, such as for infection or for post-operative complications
2. Severe Pulmonary Hypertension (PAH) (pulmonary pressure greater than 2/3 systemic) as defined by either echocardiogram (ECHO), or cardiac catheterizations or a CT-Angiogram consistent with PAH within the last 3 weeks.
3. Pneumothorax (active air leak) requiring chest tube within 72 hours of T=0
4. Active pulmonary hemorrhage within 72 hours of T=0
5. History of Grade III/IV interventricular hemorrhage without resolution or stability within 3 weeks of verifying eligibility
6. Severe congenital heart disease compromising pulmonary circulation
7. Other major congenital malformation (including but not limited to CDH) or known genetic syndromes at the discretion of the investigator
8. Use of an investigational drug within 7 days prior to confirmation of eligibility.
9. The clinical attending physician believes it is not in the subject's and/or parents/guardians best interest to participate in the trial.
The Comparison of Conventional and Advanced Bipolar Energy Modalities During Laparoscopic Staging Surgery of Gynecologic Cancers

This single-institution prospective randomized clinical trial will be performed at the Gynecologic Oncology clinic of Ankara University. Patients with endometrial cancer and cervix cancer who will be operated for staging via laparoscopic approach will be included in the study. The included patients will be randomized to two groups before surgery. During the operation of first group instruments with advanced bipolar energy will be used during lymphadenectomy and hysterectomy and salpingo-oophorectomy. In the second group the operation will be performed by conventional bipolar energy forceps. The outcome parameters to be measured are intra-operative bleeding, duration of operation, intraoperative complications, postoperative pain score, postoperative complications, postoperative duration of hospitalization, late complications such as lymphocele formation and costs.


Eligibility Criteria:
Inclusion Criteria:

* Pathologic diagnosis of endometrial or cervix cancer
* Stage I, IB1, IIA1 cervix cancer or patients with partial or complete response to chemoradiotherapy
* Clinically stage I and II endometrial cancer

Exclusion Criteria:

* Hematologic abnormality
* Coagulation disorder
* Present or past thromboembolic disease
* ECOG performance \>2
* Advanced stage disease
* Fertility preserving surgery
Systemic Effects of Lidocaine Infusion for TAP Block Catheter

Lidocaine is a local anesthetic that is usually used for nerve blocks to sensory/motor blockade. However, lidocaine can also been given intravenously, and it has been shown that this method can be used to help alleviate chronic pain. We wish to investigate if lidocaine is infused via the transversus abdominis plane (TAP) block catheter will exert systemic effect, hence reduce opioid consumption and pain score in patients compared with using local anesthetic such as ropivacaine.

Following IRB approval and written consents, patients undergoing nephrectomy were randomized into 2 groups: standard 0.2% ropivacaine infusion (control) and 0.4% lidocaine infusion for TAP catheter. The TAP catheters were placed by the surgeons under direct vision at the end of surgery before wound closure. All subjects had a general anesthetic in accordance to the discretion of the anesthesiologist in the operating room. At the end of surgery, all patients received a patient-controlled analgesia (PCA) in recovery for 48 hours. The primary outcome was the total opioid consumption at the first 27 hours post-operatively. The secondary outcomes were the total opioid consumption at 4/12/24/36/48/60 hours after the initiation of local anesthetic infusion, the numerical rating scale (NRS) at rest and on movement at 4/12/24/36/48/60 hours after the initiation of the local anesthetic infusion, the incidence of nausea and vomiting, and adverse effects.

The sample size calculation for this non-inferiority trial is based on our previous retrospective study on TAP in nephrectomy patients. A sample of 80 patients is needed, using a power of 90% with the two-sided significance level of 5%. All parametric data will be analyzed using mean and standard deviation. Non-parametric data will be analyzed using median and interquartile range. Student's t-test or Mann-Whitney U test will be used to compare between groups.

Eligibility Criteria:
Inclusion Criteria:

* Elective nephrectomy
* patients consent to study
* ASA I to III

Exclusion Criteria:

* Patient refusal
* Allergy to lidocaine,
* Patients with cardiac arrhythmias or on anti-arrhythmics or propranolol
* Wolf-Parkinson White syndrome
* Hepatic disease
A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

The purpose of this study is to is to evaluate the occurrence of late onset (i.e., greater than 5 years after treatment) adverse events of special interest (AESI) in participants who have received sub-retinal transplant of human embryonic stem cell derived - retinal pigment epithelial (hESC-RPE) cells in an AIRM-sponsored clinical trial. The events of special interest are adverse events (AEs) that are presumed to have a potential causal relationship to the hESC-RPE cells.

Participants will be contacted by the Patient Outreach Center (POC) on an annual basis to complete a questionnaire about the occurrence of AESI, as defined in the Outcome Measure section.

The questionnaire will be completed directly by the participant (via a secure web based platform) or will be administered via telephone by a POC staff member. In the event of the occurrence of a AESI, study participant will be encouraged to contact the POC as soon as possible, rather than wait for the annual questionnaire completion. Follow up data is inclusive of the 1 year in the core trial, 4 years in the long term follow up trial and 10 years in this long term safety follow up. Participation for United Kingdom participants will be life-long.

Eligibility Criteria:
Inclusion Criteria:

* Participant was treated with hESC-RPE cell therapy in an Astellas Institute for Regenerative Medicine (AIRM) sponsored clinical trial in macular degenerative disease.
* Participant is able to understand.

Exclusion Criteria:

* There are no exclusion criteria.
Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Investigator's Choice of Standard Chemotherapy in Adults Receiving First Cytotoxic Chemotherapy for Metastatic or Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) and Who Are Current or Former Smokers

The purpose of this study is to evaluate the safety and efficacy of veliparib plus carboplatin and paclitaxel versus the Investigator's choice of standard chemotherapy in adults with metastatic or advanced non-squamous non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

* Subject must be ≥ 18 years of age with life expectancy \> 12 weeks.
* Subject must have cytologically or histologically confirmed advanced or metastatic non-squamous NSCLC and are current or former smokers.
* Subject must have NSCLC that is not amenable to surgical resection or radiation with curative intent at time of screening.
* Subject must have at least 1 unidimensional measurable NSCLC lesion on a computed tomography (CT) scan as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Exclusion Criteria:

* Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
* Subject has a known hypersensitivity to platinum compounds.
* Subject has peripheral neuropathy ≥ grade 2.
* Subject has squamous NSCLC, or an untreated known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement.
* Subject has received prior cytotoxic chemotherapy or chemoradiotherapy for NSCLC.
Safety Study of an Intravenous Staphylococcus Aureus Immune Globulin (Human), [Altastaph] in Low-Birth-Weight-Neonates

The main objective will be to test the safety of two intravenous infusions of Altastaph, a human immunoglobulin product. The study will also test the ability of Altastaph to protect against S. aureus infection.

Survival of Very-Low-Birth-Weight (VLBW) infants (\<1500g at birth) has improved dramatically, but these patients remain subject to significant morbidity and mortality due to Staphylococcus aureus infection. S. aureus infection is a relatively common event in VLBW neonates, occurring in approximately 3.4% of very low birth weight neonates and accounting for 15-20% of all infections in this patient population. This controlled study will assess the safety, pharmacokinetics, and preliminary efficacy of Altastaph in LBW neonates. The study will be stratified by birth weight and include up to 200 LBW neonates, 3 to 7 days of age.

Eligibility Criteria:
The subject must conform to all of the following (Inclusion Criteria):

* Neonate with a birth weight between 501 and 1500 grams inclusive;
* Between 3 and 7 days of age, inclusive, at the time of first infusion (Day 0);
* Expected to survive at least 48 hours after infusion;
* Free of overt systemic infection, as determined by history, physical examination, radiologic studies, or laboratory studies including microbiology data; clinical safety tests required can be completed up to three (3) days prior to the infusion of the study product;
* Direct bilirubin less than or equal to 2.0 mg/dL;
* Serum creatinine level of less than or equal to 2.0 mg/dL; and
* Hemodynamically stabile; if the subject is receiving cardiac support including anti-arrhythmics, pressors, or cardiac pacing, the subject must be stable on that cardiac support and be expected not to require this support indefinitely.

The subject must not have any of the following (Exclusion Criteria):

* Known HIV infection, as documented by maternal history or positive PCR in the infant;
* Severe congenital anomaly or genetic disorder known to impact immune competence;
* Prior administration of any immune globulin;
* Any history, in the infant subject or its mother, of hypersensitivity or severe vasomotor reaction to any human blood product;
* Cyanotic congenital heart disease; and
* Central nervous system shunt
Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.

A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT)

However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT

Eligibility Criteria:
Inclusion Criteria:

* Patients ages between 0 to and 65 years of age.
* Patient must have a genotypically HLA-identical sibling, a phenotypically matched first-degree relative or an unrelated matched donor.
* Acute lymphocytic leukemia (ALL) in CR1 with high risk features
* Acute myeloid leukemia (AML) in CR1 with high risk features defined as:

  i. Greater than 1 cycle of induction therapy required to achieve remission, ii. Preceding myelodysplastic syndrome (MDS) other than myelofibrosis, secondary AML iii. Presence of Flt3 mutations or internal tandem duplications, iv. FAB M6 or M7 classification or adverse cytogenetics for overall survival such as those associated with MDS, M6, M7 leukemia, or v. Complex karyotype \[\> 3 abnormalities\]
* Acute Leukemias in 2nd or greater remission
* Refractory or Relapsed AML
* AML transformed from MDS
* Myelodysplastic syndrome (MDS) beyond refractory anemia
* Chronic myeloid leukemia (CML)
* Chronic myelomonocytic leukemia
* Philadelphia-negative myeloproliferative disorder
* Relapsed chemotherapy-sensitive Hodgkin's or Non-Hodgkin's lymphoma
* Multiple Myeloma-Stage III

Exclusion Criteria:

* Prior autologous or allogeneic stem cell transplant.
* Performance status greater than 2
* Active infection.
* Inadequate cardiac function; arrythmias or symptomatic cardiac disease.
* Inadequate pulmonary function; FEV1, FVC, DLCO \<50% of predicted
* Inadequate Serum creatinine clearance \<60
* InadequatebHepatic function
* Positive serology for HIV-1, 2 or HTLV-1, 2.
* Pregnancy. Female patient must have negative pregnancy test
Reducing Distress and Improving Self-Care in Diabetes

To date, there have been few practical, evidenced based interventions that are directed at patients with Type II Diabetes who are experiencing depressed and/or emotional distress in primary care settings. This study will (1) combine two existing, evidenced-based, interventions (a computer automated, diabetes specific self-management program (CASM) vs. a self-care program plus a live problem solving distress-reduction program (CAPS) vs. a lifestyle and activities education program (LEAP-AHEAD)) into a practical, 3-arm clinical trial with a highly distressed multi-ethnic patient sample, and (2) evaluate the intervention using the RE-AIM framework, sharing the results through a comprehensive dissemination package.

Hypothesis 1: The combined CASM and CAPS arms will be superior to the LEAP-AHEAD group on the primary outcomes at follow-up.

Hypothesis 2: The CAPS arm will be superior to the CASM arm on primary outcomes at follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of type 2 diabetes (confirmed using the Wellborn criteria for a minimum of 12 months)
* Be between 21 and 75 years of age
* Speak and read Spanish or English fluently
* In addition, based on the telephone screening, patients will have to display a high level of diabetes distress and a deficit in at least one of three self-management areas (diet, physical activity, medication adherence). This is defined as having an average item score \> 3.0 on 2 items from the regimen distress and emotional burden sub scale of the DDS and indication of problems in management on at least one scale of the SDSCA (i.e., endorsing having a healthy eating plan on less than 5 days/week, 30 minutes physical activity less than 5 days/week, or forget to take medicines more than 1 day/week).
* Have access to the internet

Exclusion Criteria:

* Have major disabilities or severe disorders (MI in the last 12 months, psychosis, on end-stage dialysis, dementia)
* Have current MDD (based on the PHQ8).
Ball and Socket Versus Locator Attachment Retained Implant Overdentures

Will the use of locator attachment influence the muscle efficacy when compared to ball and socket attachment in mandibular implant overdenture? '

In this study we will use a two different types of attachments in implants overdenture in mandibular completely edentulous patients to increase the retention and stability of the denture and this can be recognized by record the masticatory function of the muscles of the mandibular jaw.

Eligibility Criteria:
Inclusion Criteria:

- Upper and lower completely edentulous patients. Acceptance of the existing denture if it is good, or constructing a new one if it is defected.

Patients with adequate bone quality and quantity. Tooth extracted not less than 6 month.

Exclusion Criteria:

1. Young patients.
2. Diseases affecting neuromuscular coordination.
3. TMJ diseases.
4. Soft tissue abnormalities.
5. Bony exostosis.
6. Parathyroid dysfunction
7. uncontrolled Diabetes
8. Radiotherapy to the neck or head
9. Pregnancy.
10. Drug and alcohol dependency.
11. Smokers.