cyrilzakka/clinical-trials huggingface dataset:
Modulating Context Generalization Through Transcranial Direct Current Stimulation

Behavioral adaptation is particularly relevant to anxiety and related disorders, where exposure-based therapies rely on such adaptation as part of behavior therapy.. However, while initial fear reactions generalize easily across contexts, subsequent adaption of behavior through learning is context-specific. The primary goal of this study is to investigate whether transcranial direct current stimulation (tDCS) can be used to acutely impact generalization of subsequent learning across contexts in an experimental paradigm. As part of this study, participants will complete a clinical interview and questionnaires, as well as a computer task asking them to make choices between stimuli on the screen and during which they may or may not receive tDCS.


Eligibility Criteria:
Inclusion Criteria:

1. Primary diagnosis of an anxiety or related disorder, (defined as panic disorder, social anxiety disorder, generalized anxiety disorder, obsessive-compulsive disorder, and/or post-traumatic stress disorder);
2. aged 18-55;
3. ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent;
4. Stable psychiatric medication use for at least 6 weeks.

Exclusion Criteria:

1. Lifetime history of psychotic symptoms or bipolar disorder,
2. Current substance use disorder;
3. Acute suicidality or homicidality,
4. Significant neurological disorder,
5. Any problems that would interfere with study participation, significant or unstable medical disorders and tDCS-related contraindications (e.g., implanted metallic substances, pregnancy, holes in the skull, skin abnormalities under stimulation sites).
Stretching Versus Traction in Patients With Cervical Radiculopathy.

The purpose of the study is to compare the effects of traction decompression and neck muscle stretching on the magnitude of Flexor Carpi Radialis H-Reflex(HR), Neck Disability Index (NDI), and Visual Analogue Scale (VAS) pain scores in patients with cervical radiculopathy.

Cervical traction has long been used to relieve compression of nerve roots caused by intervertebral discs. Yet, there is lack of knowledge that compares the effect of traction decompression with neck muscles stretching in patients with cervical radiculopathy

Eligibility Criteria:
Inclusion Criteria:

* Patients should have C5-C6 and C6-C7 paramedian disc protrusion manifested by unilateral symptoms in C6-C7 roots dermatome and myotomes of the upper extremities.
* They were diagnosed as cervical disc protrusion (C5- C7) for at least three months.
* All patients should have a second grade of disc bulge (2-3mm) which was detected from T2 axial view of MRI.

Exclusion Criteria:

* Patients will be excluded from the study if they have upper cervical spine disc pathology, cord compression and upper motor neuron symptoms, curvature abnormalities of the neck including reversed curve (kyphotic) and deformities, cervical rib syndrome, double crush syndrome, diabetic neuropathy, text neck , short neck (Churchill neck), Marked facet joint, neuro-central joint arthropathic pathology, osteoporosis.
Study to Determine Results of Vibratory Stimulus on Subject's Neck

This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement.

This study will validate whether an external vibratory stimulus applied to a subject's neck causes head, neck or jaw movement, and provide information regarding the optimum location and variable vibration parameters of vibratory stimulus on a subject's neck to cause head, neck, or jaw movement. The study will also provide information whether the subject experienced or did not experience a change in sleep stage or arousal by vibratory stimulus on a subject's neck. The data gathered from this study will be used for future studies in analyzing whether such vibratory stimulus can serve as a potential treatment for sleep disorders, such as snoring and obstructive sleep apnea.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ages 18 to 80 years old
* Able to provide written informed consent for themselves and comply with study procedures.

Exclusion Criteria:

* Known hyposensitivity or hypersensitivity to vibrations on neck.
* Neurological disorder such as seizure disorder or narcolepsy.
* Psychiatric disorders currently not under control.
* Insomniacs.
* Pregnant women.
A Study Of The Evaluation Of Patients Opulation With Erectile Dysfunction, Treated With Sildenafil

In the present study, it is planned to observe a population of 100 ED patients treated previously with udenafil and for whom their physician decided to switch them to sildenafil because of poor udenafil tolerance and/or poor efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Male patients aged ≥ 18 years.
* Clinical diagnosis of erectile dysfunction supported by a total score of less than or equal to 21 according to Sexual Health Inventory-Male (SHI-M).
* Patients having a sexual partner throughout the study.
* Patients having been switched to sildenafil after a previous treatment with udenafil proved ineffective and/or was poorly tolerated. The evaluation of udenafil ineffectivness should be performed after attempt intercourse 2 times a week over the course of four weeks.

Exclusion Criteria:

* The patients for whom sildenafil is contraindicated according to the Local Product Document (LPD). (See appendix D)
* The patients for whom sexual activity is not indicated.
Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers

This study will evaluate the safety of phenylephrine hydrochloride 10 mg + acetaminophen 500 mg + dimethindene maleate 1 mg compared to phenylephrine hydrocloride 10 mg alone in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers between 18 and 50 years;
* Clinical examination without abnormal findings
* Ability to understand the nature and purpose of the study, including the risks and adverse effects

Exclusion Criteria:

* Any cardiovascular disease, coronary artery disease, circulation problems or history of stroke, peripheral vascular disease or arrhythmia
* History of serious adverse reactions or hypersensitivity any drug
* Hypersensitivity to the drug study drugs or chemically related compounds
Efficacy of Platelet-rich Plasma in Management of Anosmia

Olfactory dysfunction is a prevalent disorder that affects up to 20% of the general population and has significant effects on a person's quality of life as well as increased morbidity and mortality (Croy I et al., 2014;Nordin S et al

.,2008). Anosmia is the inability to perceive the odor or a lack of functioning olfaction; it may be temporary or permanent. Organic anosmia is loss of smell due to nasal obstruction caused by sinonasal diseases (as nasal polyps, tumors, postoperative) preventing odorant molecules from reaching olfactory mucosa. Functional anosmia affects up to 5% of the general population and 10% of those older than 65 . Functional anosmia is due to damage of peripheral olfactory area causing permanent loss of smell as post-traumatic, post viral infection. . 20% of individuals aged 20 to 90 years have impaired olfactory Function . The etiology of olfactory dysfunction is quite varied, including post viral posttraumatic, and idiopathic loss of smell. Unfortunately, with these etiologies, the likelihood of spontaneous recovery is generally poor with only approximately one-third of people regaining function and the duration of loss negatively correlating with recovery rate . Treatment for olfactory dysfunction is also limited. Best evidence studies recommend olfactory training and topical steroid nasal irrigations as potential therapeutics, yet both have limited efficacy . PRP is an autologous materials known to have anti-inflammatory and proregenerative properties including up regulation of growth factors including transforming growth factor, vascular endothelial growth factor, epidermal growth factor, and insulin-like growth factor. It has been used as a safe therapy effective in treating inflammation, wound healing, and peripheral neuropathies in other clinical settings. In particular, PRP has been shown to promote axon regeneration and neuroregeneration .


Eligibility Criteria:
Inclusion Criteria:

* sex:both gender.
* UPSIT score up to 10 of 40
* all patients who suffer from anosmia
* normal airway passage
* CT free of any sinonasal obstrucive lesions.

Exclusion Criteria:

* Age: below 18 years old and above 50years old.
* All patients with bilateral nasal obstruction related to chronic sinusitis, bilateral nasal polyposis,septum ,turbinate hypertrophy,tumors.
* UPSIT score more than 10 of 40.
* Traumatic causes of anosmia.
* All patients with medical history of blood diseases and diabetic and hypertensive patients.
* any medical treatment affect coagulation or bone marrow for 2 weeks prior to testing ..
A Study to Evaluate the Pharmacokinetic Drug Interaction After Oral Concurrent Administration of Fimasartan and Amlodipine in Healthy Male Volunteers

To evaluate the pharmacokinetic drug interaction after oral concurrent administration of fimasartan and amlodipine in healthy male volunteers


Eligibility Criteria:
Inclusion Criteria:

* age: 20 - 40 years
* sex: male
* body weight: greater than 55 kg
* written informed consent

Exclusion Criteria:

* known allergy to Fimasartan and amlodipine
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism
* history of any serious psychological disorder
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day 3 month ago
* participation in a clinical trial during the last 2 months prior to the start of the study
Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age

The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment.

The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects \> or = 12 years of age over the course of 6 weeks treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age: 12 years of age or older
* Non-, former or current smokers with a documented smoking history of ≤ 10 pack years
* Asthma diagnosis as defined by the National Institutes of Health
* Best FEV1 of 50% to \<80% of the predicted normal value
* Post-albuterol FEV1/FVC ratio of \>0.70 at Visit 1/1a (between 5:00AM and 12:00 noon)
* ≥ 12% and ≥200mL reversibility of FEV1
* Must have been using FP 100mcg inhalation powder BID for at least 2 weeks just prior to Visit 1.
* Must be able to replace their current short-acting beta2-agonists with albuterol inhalation aerosol
* Must be able and willing to give written informed consent to take part in the study.
* Must be able and willing to comply with all aspects of the study including completion of daily e-Diary.

Exclusion criteria:

* History of life-threatening asthma
* Recent asthma exacerbation
* Concurrent respiratory disease
* Recent respiratory infection
* Liver disease
* Other concurrent diseases/abnormalities
* Oral candidiasis
* Drug allergy
* Milk protein allergy
* Immunosuppressive Medications
* Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1
* OATP1B1 substrates within 4 weeks of Visit 1
* Cytochrome P450 3A4 (CYP 3A4) Inhibitors
* Cytochrome P450 3A4 (CYP 3A4) Inducers
* Investigational Medications
* Compliance: any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol
* Affiliation with Investigator's Site
Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine System to actively immunize against Enterotoxigenic Escherichia coli disease in a field setting.


Eligibility Criteria:
Inclusion Criteria:

* 18-64 years of age at date of first vaccination
* Good health as determined by medical history and physical inspection
* Females of child-bearing potential must have a negative pregnancy test prior to first vaccination in teh Country of Origin; females of child-bearing potential must agree not to become pregnant throughout the duration of the study
* Subjects must have planned travel to an area within 3 hours traveling distance of Mexico City, Cuernavaca, Guadalajara, Oaxaca, or San Miguel de Allende, Mexico or Antigua, Quezaltenango, Guatemala City, or Solola, Guatemala for a minimum duration of stay 7 days (no maximum stay is specified for inclusion).
* Subject must be able to communicate in English

Exclusion Criteria:

* Abnormalities as determined by the Investigator/clinician during physical inspection
* Participated in research involving investigational product within 30 days before planned date of first vaccination
* Ever received LT, ETEC, or cholera vaccine
* History of diarrhea while traveling to a developing country within the last year
* Women who are pregnant or breastfeeding
* Clinically significant underlying enteric, pulmonary, cardiac, liver or renal disease
* History of Irritable Bowel Syndrome
* Seizure disorder within the last year
* Current use of immunosuppressive therapy (excluding inhaled steroids) or current immunodeficiency
* Known or suspected alcohol abuse or illicit drug use within the last year
* Medical history of HIV, HBV, or HCV
* An employee of a study site
* Known allergies to any component of the vaccine, including adhesives
* Planned use of antibiotics with known activity against gram negative facultative anaerobes
* Planned use of antacids, antidiarrheals, loperamide, bismuth subsalicylate, diphenoxylate or similar during the surveillance phase of the study
* An employee of Intercell (global) or an immediate family member
Comparison of HT Concomitant With RT vs RT Alone in Patients With a Detectable PSA After Prostatectomy

The purpose of this study is to select the best therapeutic strategy in studying the effectiveness of the association of a short duration hormonal therapy and radiotherapy compared with radiotherapy alone, in patients with a detectable PSA after radical prostatectomy.

Study the effectiveness of the association of a short duration hormonal therapy by degarelix (Firmagon ®) and radiotherapy, with radiotherapy alone on survival without events in the treatment of detectable PSA after radical prostatectomy.

122 patients should be included over a period of 2 years. Patients will be treated according to the following scheme:

* Arm A (61 patients) : Pelvic Radiotherapy: 46 Gy and prostate only boost up to 66 Gy
* Arm B (61 patients) : Arm A + hormonal therapy by degarelix during 6 months

Eligibility Criteria:
Inclusion Criteria:

1. Patient with localized prostate adenocarcinoma treated with radical prostatectomy (whatever the initial prognostic stage)
2. R0 or R1
3. pN0 or pNx
4. Post prostatectomy PSA ≥0.2 ng/mL measured between 1 month and 4 months after surgery and increasing to a second test performed between 1 et 8 months after the post prostatectomy dosage
5. PSA ≤2 ng/mL at moment of the randomisation
6. No clinical signs of progressive disease (bone scan or PET scan or abdominal and pelvic scan or MRI): N0, M0
7. Neutrophils ≥1500/mm³; platelet count ≥100 000/mm³
8. Bilirubin ≤ upper limit of normal (ULN); alkaline phosphatase (ALP), aspartate aminotransferase (AST), and Alanine aminotransferase (ALT) ≤1.5 ULN
9. Creatinine \<140 µmol/L (or clearance \>60 mL/min)
10. Normal fasting glucose
11. Eastern Cooperative Oncology Group (ECOG) ≤1
12. Age \>18 years
13. Life expectancy ≥10 years
14. Patients with invasive cancer in complete response for more than five years are eligible
15. Patients who have received the information sheet and signed the informed consent form
16. Patients with a public or a private health insurance coverage

Exclusion Criteria:

1. Prostate cancer histology other than adenocarcinoma
2. Patients pN1, N1 and M1
3. History of pelvic radiotherapy
4. Contraindication to pelvic irradiation (eg, scleroderma, chronic inflammatory bowel disease, etc.)
5. Testosterone ≤0.5 ng/mL
6. History of surgical castration
7. Previous treatment by hormonotherapy
8. Antineoplastic treatment in progress
9. History of another invasive cancer within 5 years before inclusion (with the exception of a basal cell skin carcinoma treated)
10. Known pituitary adenoma
11. Severe hypertension uncontrolled by appropriate treatment (160 mm Hg systolic and/or 90 mm Hg diastolic)
12. Patient with a corrected QT interval (using Fridericia correction) greater than 450 msec
13. Individual deprived of liberty or placed under the authority of a tutor
14. Unable to undergo medical monitoring test for geographical, social or psychological reasons
15. Known hypersensitivity to the treatment in test
16. Administration of an investigational therapeutic within 28 days prior to the screening visit or more if treatment is likely to influence the outcome of this
Quantitative Analysis of EEG Changes in Response to Nociception

This study will quantify the nociception using Analgesia Nociception Index (ANI) during general anesthesia and analyze the differences in EEG depending on the degree of nociception. Additionally, the investigators will quantify the nociception during recovery and analyze the differences in EEG depending on the degree of nociception.


Eligibility Criteria:
Inclusion Criteria:

• Patients aged ≥ 19 undergoing laparoscopic surgery

Exclusion Criteria:

* Patients with arrhythmia
* Patients with pacemaker implantation
* Patients who have received a heart transplant
* Patients taking medications that may affect ANI (antimuscarinics, alpha-agonist, beta blockers, etc.)
* Patients with central nervous system disease (dementia, stroke, epilepsy, brain tumor, psychiatric disease, etc.)
* Patients who cannot understand the consent form
ACB + IPACK Block With or Without Local Infiltration in RA-TKA

The purpose of this study is to compare the outcomes of an Adductor canal block (ACB) + interspace between the popliteal artery and the capsule of the knee (IPACK) block along with a single intraoperative injection of a standard local anesthetic that includes Ropivacaine, Epinephrine, Ketorolac, Clonidine and saline to an ACB + IPACK block without the intraoperative injection of a standard local anesthetic in patients undergoing Robotic Arm-Assisted TKA (RA-TKA).


Eligibility Criteria:
Inclusion Criteria:

1. Patient is over the age of 21
2. Patient is scheduled to undergo a unilateral, primary TKA, secondary to osteoarthritis
3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization documents
4. Patient is able to read and speak English.

Exclusion Criteria:

1. Patient is under the age of 21
2. Patient's primary diagnosis is not osteoarthritis (e.g. post-traumatic arthritis)
3. Patient is scheduled to undergo a bilateral TKA surgery
4. Patient is unable to read and speak English
Effects of Spinal Cord Stimulation

The goal of this interventional study is to test effects of spinal cord stimulation in patients receiving treatment for their chronic pain. The main question of the study is:

• What is the effect of spinal cord stimulation when compared to placebo? Participants will rate their pain with their usual spinal cord stimulation on and off.


Eligibility Criteria:
Inclusion Criteria:

* Patients (\>18 years of age) with SCS implanted to treat chronic pain.
* Patients who consent to participation and can cooperate in the study.
* Use of continuous paresthesia-free SCS for minimum 6 months prior to participation in the study.
* Pain score of 7 or less on a 0-10 scale in the most painful area treated with SCS, rated upon inclusion.
* Patients not receiving other neuromodulation treatment.
* Patients who have not undergone changes in their (pain relevant) medication during the last 30 days (pro necessitate medication allowed).
Laparoscopic Roux-en-Y Gastric Bypass and Gastro-esophageal Reflux

Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is considered the weight loss procedure of choice for patients suffering of gastro-esophageal reflux (GER). However, long term instrumental evaluations of GER after LRYGB are not available.

The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on gastro-esophageal function.

Consecutive morbidly obese patients selected for LRYGB were included in a prospective study. The investigators performed clinical evaluation with GERD-HRQoL and GIS questionnaire, upper endoscopy, esophageal manometry and 24h-impedance pH monitoring (24h-MII-pH) preoperatively and at 12 and 60 months after surgery. Patients were divided into 2 groups according to the presence of GER at preoperative 24h-MII-pH.

Eligibility Criteria:
Inclusion Criteria:

* history of obesity exceeding 5 years
* documented previous weight loss attempts,
* body mass index (BMI)) of 40-50 kg/m2
* age of 18-60 years.

Exclusion Criteria:

* contraindications to pneumoperitoneum
* large esophageal hiatal hernia
* pregnancy,
* drug or alcohol abuse,
* psychological disorders (e.g., bulimia, depression)
* hormonal or genetic obesity-related disease
* previous gastric surgery
Evaluation of Amino Acid Metabolism Changes in Ovarian Cancer

Ovarian cancer is associated with undernutrition in more than half of all cases. The current management of undernutrition-cachexia in cancer is not specific. It is well recognized that the nutritional support currently offered to cancer patients is not effective in combating cachexia, which progresses inexorably, leading to the patient's death. It is therefore necessary to offer specific and adapted care, in particular by optimizing the quality of nitrogen intake. To achieve this, the investigators first need to define the specific amino acid requirements of cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of high-grade serous ovarian cancer not immediately resectable (stage III or IVa) managed at Grenoble Alpes University Hospital.
* Affiliation to the French social security system.
* Able to understand and follow the instructions necessary for the conduct of the trial, and having given written consent for the study.

Exclusion Criteria:

* Significant active comorbidity requiring long-term drug treatment (e.g. organ failure, diabetes) or history of pathology likely to impact amino acid metabolism (e.g. urea or homocysteine cycle abnormalities, tyrosinemia, alkaptonuria, hyperprolinemia, organic aciduria).
* vegetarian or vegan diet
* difficult venous access
* Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure).
* Subject receiving more than 4,500 euros in compensation for participation in other research involving the human body in the 12 months preceding this study.
* Significant biological abnormalities (not explained by the underlying pathology for women with ovarian cancer)
* Liver metastases