cyrilzakka/clinical-trials huggingface dataset:
Drug Use Investigation of Jzoloft.

The objective of this surveillance is to collect information about 1) adverse drug reactions not expected from the LPD (unknown adverse drug reactions), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.

All the patients whom an investigator prescribes the first Sertraline hydrochloride should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility Criteria:
Inclusion Criteria:

Patients need to be taking Sertraline hydrochloride in order to be enrolled in the surveillance.

Exclusion Criteria:

Patients not taking Sertraline hydrochloride.
Features and Outcomes of Patients With Reactive Arthritis

The aim of this study is to assess the incidence and the clinical and therapeutic characteristics of reactive arthritis and to compare them with those of a historical cohort. We hypothesised that improved hygiene together with prevention and treatment of sexually transmitted infections may have decreased the incidence of reactive arthritis.


Eligibility Criteria:
Inclusion Criteria:

* reactive arthritis diagnosed in one of the two rheumatology departments from Centre Hospitalier Lyon Sud or Besançon

Exclusion Criteria:

* presence of other known causes of arthritis, such as other defined spondyloarthritides, septic arthritis, Lyme disease, microcrystalline arthritis or rheumatoid arthritis
Laparoscopy-assisted Proximal Gastrectomy Versus and Laparoscopy-assisted Total Gastrectomy

The choice of surgical strategy for patients with proximal gastric cancer is controversial mainly because proximal gastrectomy is infamous for high rates of reflux symptoms and anastomotic stricture. but there are no prospective randomized trials until now.

The primary end point of this study is whether the rate of reflux esophagitis is different or not between LAPG and LATG. Through this study, we

Prospective Randomized Clinical Trials between Laparoscopy-assisted Proximal Gastrectomy and Laparoscopy-assisted Total Gastrectomy.

LAPG reconstruction: double tract reconstruction (3 anastomosis, intracorporeal Roux-en Y esophago-jejunostomy, extracorporeal gastro-jejunostomy 10cm below esophago-jejunostomy,extracorporeal jejuno-jejunostomy 20cm below gastro-jejunostomy)

LATG reconstruction: intracorporeal Roux-en Y esophago-jejunostomy

Primary end point : incidence of reflux esophagitis after operation

Sample Size : LAPG 97 cases, LATG 97 cases (p1=0.018 p2=0.018, a=0.05, b=0.80) Non-inferiority test, non-inferior margin (delta) : 0.05. Sample size calculated by our MRCC(Medical Research Collaborating Center, http://mrcc.snubh.org)

Study duration : 48 months (enrollment 36months, follow-up 12months)

Reflux esophagitis evaluation methods

1. Ambulatory 24hr-pH esophageal holter monitoring for acid reflux
2. DISIDA scan for bile reflux
3. Endoscopic evaluation (Grading according to LA classification)
4. Visick score (subjective symptoms)
5. EORTC sto 22 and GIQLI evaluation (Quality of Life)
6. Nutritional Benefits (Body weight, Triceps Skin folds Thickness, Blood test)
7. Upper gastrointestinal study
8. Gastric emptying scan

Eligibility Criteria:
Inclusion Criteria:

* Age 20\~80
* Informed consent
* No other malignancies
* Proximal gastric cancer met by following conditions

  1. Lesion located on proximal stomach (upper one third)
  2. Lesion below 5cm in size
  3. Lesion confined to proper muscle depth (cT2)
  4. No evidence of metastatic enlarged LN on #5, 6, 4d, 10 basins and other distant metastasis. (cN1)

Exclusion Criteria:

* If patients is only suitable to total gastrectomy, he will be excluded.
Insulin Resistance in Patients With Major Depression

The purpose of this study is to study the relationship between insulin and glucose action and neuropsychological functioning (memory, attention, general thinking abilities) in persons with depression.


Eligibility Criteria:
Inclusion Criteria:1)Willingness to sign the Human Subject Protection Consent Form prior to enrollment into the study.

2)Men and women ages 20 to 65 years of age. 3)Diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (MDD) or depressive episode of bipolar disorder (Bipolar I, II or NOS), based on a Structured Clinical Interview for DSM-IV Axis I disorders (SCID) and confirmed by a psychiatrist.

4) Depression severity as defined by score of \<17 on the 21-item Hamilton Rating Scale for Depression and no psychiatric admission within 6 months from study entry and no suicide attempt within the last 12 months.

5)Adequate visual and auditory acuity to allow neuropsychological testing. 6)Stable regime of psychiatric medications for 1 month prior to insulin test. Exclusion Criteria:1)Diagnosis of possible or probable cognitive impairment.

2)For women only: pregnancy, breastfeeding. 3)Personal history of Type I or Type II diabetes. 4) Unstable cardiovascular disease or other major medical condition, or history of myocardial infarction within the previous year.

5)Significant cerebrovascular disease, as evidenced by neurological examination, uncontrolled hypertension (systolic blood pressure \> 170 or diastolic blood pressures \> 100).

6) Current drug or alcohol abuse. 7)History of neurological disorder, e.g. multiple sclerosis, stroke etc. 8)Use of any drug that may significantly affect psychometric testing, or the insulin testing
Benefits of Dry Needling in Trigger Points on Autonomic Nervous System and Corporal Composition in Patients With Fibromyalgia Syndrome

This study evaluates the benefits of dry needling in trigger points on autonomic nervous system, photoelectric plethysmography, body composition in patients with fibromyalgia syndrome.

Dru needling can be developed on active trigger points. Myofascial trigger points can be active or latent. An active myofascial trigger point pain causes giving a specific pathological picture. We will conduct a location of myofascial trigger points following the illustrations location myofascial trigger points that indicate Travell and Simons both left-sided and right.

Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia syndrome diagnosis.
* Aged from 18 to 65 years.
* No regular physical activity.
* Limitation of usual activities due to pain on at least 1 day in the previous 30 days.
* Agreement to attend evening therapy sessions.

Exclusion Criteria:

* Severe physical disability.
* Comorbid conditions (eg, morbid obesity, inflammatory diseases, irritable bowel syndrome, interstitial cystitis).
* Uncontrolled endocrine disorders (eg, hyperthyroidism or hypothyroidism, diabetes).
* Malignancy.
* Psychiatric.
* Illnesses (eg, schizophrenia or substance abuse).
* Medication usage other than as-needed analgesics (excluding long-term narcotics).
* History of surgery.
* History of whiplash injury.
* Presence of a score \>9 points in the Beck Depression Inventory.
A Clinical Trial to Evaluate the Safety and Pharmacokinetic

A phase 1 clinical trail to evaluate the safety and pharmacokinetic characteristic after administration of fixed-dose combination or loose combination of HUG186 in healthy adult male or menopausal female volunteers


Eligibility Criteria:
Inclusion Criteria:

1. Men, age≥19 years of age, Postmenopausal women are eligible. Postmenopausal is defined as any of the following:

   * Amenorrhea for 12 or more months
   * FSH and estradiol in the postmenopausal range per local normal range.
2. Body weight of ≥ 55 kg, BMI 18.5 to 30.0
3. No morbid symptom or sign, based on physical examination, with no innate or chronic disease.
4. Subject that is considered appropriate for participating in the study by an investigator, based on clinical laboratory test (hematology, clinical chemistry, urinalysis) that is performed according to the characteristics of investigational drugs.
5. Subject that agree to apply sun cream in case of daylight exposure for more than 1hours
6. Subjects must be able to listen to and understand the detailed statement of informed consent, and willing to decide to participate in the study, follow the study directions and provide written informed consent.

Exclusion Criteria:

1. A clinically significant disease or history in hepatobiliary system, kidney, digestive system, respiratory system, hemato-oncological system, endocrine system, neuro-psychiatric system, musculo-skeletal system, immune system, otorhinolaryngological system or cardiovascular system.
2. A history of hypersensitivity to investigational drugs and its additives or clinically significant hypersensitivity to any other drug.
3. History of drug abuse, or positive in drug screening test.
4. Use of inducer or inhibitor of metabolic enzymes for drugs like barbiturate.
5. Use of any prescribed drugs or herbal remedies within 2 weeks, or use of any over-the-counter medication within 1 week prior to the first administration of investigational drug, and this will affect this study or the safety of the subjects at discretion of study investigator.
6. Participation in another clinical trial or a bioequivalent study within 3 months prior to the first administration of investigational drug (The finish time of previous study is the day of the last administration of study drug)
7. Whole blood donation within 2 months or component donation within 1 month, prior to the first administration of investigational drug, or transfusion within 1 month prior to the first administration of investigational drug.
8. Prolonged excessive alcohol consumption (\>21 units/week, 1 unit=10g of pure alcohol), or subjects who can not abstain from drinking from 24 hours prior to hospitalization until the discharge.
9. Smoking more than 10 cigarettes per day, excessive caffeine consumption (example: instant coffee \> 5 cups/day)
10. Subjects who are judged to be inappropriate for this study by investigators according to other reasons including clinical lab test result
Efficacy and Safety Study of Ataciguat Versus Placebo in Patients With Neuropathic Pain

The primary objective of this study is to assess the efficacy of ataciguat versus placebo in reducing pain intensity in patients with neuropathic pain.

The secondary objective is to assess the safety and tolerability of ataciguat versus placebo.

This study consists of two consecutive 28 day treatment periods which are separated by a 2 week medication free period and a safety follow-up period of 2 weeks after the second treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic neuropathic pain due to diabetic polyneuropathy or a nerve lesion following surgery. The pain must be present for more than 3 months.

Exclusion Criteria:

* Presence or history of cancer within the past five years
* Patients with a history of HIV infection
* Patients with active hepatitis B or C
* Patients with any pain other than the neuropathic pain of greater or equal severity
* Patients with a diabetes mellitus for less than 6 months

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Ganciclovir 0,15% Ophthalmic Gel in the Treatment of Adenovirus Keratoconjuntivitis

Ganciclovir ophthalmic gel delivers multiple advantages in the treatment and prophylaxis of herpetic keratitis and shows potential for effectiveness against other viral ocular infections. The majority of adenoviral conjunctivitis will resolve without damaging vision, however, the investigators have no way to determine which cases will progress to ocular complications such as corneal infiltrates and pseudomembranes. Our purpose is to evaluate the efficacy of the Ganciclovir gel 0.15% in preventing ocular complications after adenoviral conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* onset of symptoms for five days or less
* eighteen years old or more
* not pregnant or breastfeeding
* be able to understand and sign the consent term

Exclusion Criteria:

* use of antibiotic or corticoid 30 days before
* monocular vision
* keratopathy or other ocular diseases
Pilates in Women With Chronic Low Back Pain

The purpose of this study is to evaluate the effect of a Pilates exercise program (PEP) on the flexo-relaxation ratio (FRR) of the erector spinae (ES) muscle during standing maximal trunk flexion/extension in women with chronic low-back pain (LBP). A secondary goal is to investigate the effect of PEP on full trunk flexion ROM (TFRoM), pain intensity and functional capacity and analyse their relationship with the FRR.

Purpose: To evaluate the effect of a Pilates exercise program (PEP) on the flexo-relaxation ratio (FRR) of the erector spinae (ES) muscle during standing maximal trunk flexion/extension in women with chronic low-back pain (LBP). A secondary goal was to investigate the effect of PEP on full trunk flexion ROM (TFRoM), pain intensity and functional capacity and analyse their relationship with the FRR. Material and methods: Thirty women with chronic LPB were randomly assigned to either PEP (EG, n=15) or control group (CG=15). EG followed an 8-week PEP while no specific intervention was carried out on the controls. Before and after this period all variables were recorded.

Eligibility Criteria:
Inclusion Criteria:

* lumbar or lumbosacral pain (with or without radicular pain) for at least six months;
* a score higher than 6/50 on the Oswestry Disability Index (ODI)
* absence of any back treatment for the last three months.

Exclusion Criteria:

* body mass index \> 30 kg/m2
* prior surgery of the pelvis,
* spinal column or lower extremity
* scoliosis;
* systemic or degenerative disease
* history of neurological diseases or deficits not related to back pain
* pregnancy or hypertension.
Evaluate Immunogenicity, Safety, and Reactogenicity of Rotavac® in Healthy Infants Aged Between 6-8 Weeks in Vietnam

An open label study to evaluate immunogenicity, safety, and reactogenicity of Rotavac® (live attenuated oral rotavirus vaccine) as a 3-dose series in healthy infants aged between 6 weeks and 8 weeks in Vietnam.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants as established by medical history and clinical examination before entering the study.
* Age: 6-8 weeks
* Weight ≥ 2.5kg at birth.
* Infants received EPI vaccines at birth (i.e., OPV, BCG and/or Hep B)
* Parental ability and willingness to provide informed consent.
* Parent who intends to remain in the area with the participant during the study period.

Exclusion Criteria:

* Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
* Presence of fever (temperature ≥37.5oC) or hypothermia (temperature ≤35.5oC) on the day of enrollment (temporary exclusion).
* Concurrent participation in another clinical trial.
* Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the infant's health or is likely to result in non-conformance to the protocol.
* History of congenital abdominal disorders, intussusception, abdominal surgery
* Known or suspected impairment of immunological function based on medical history and physical examination.
* Prior receipt of rotavirus vaccine.
* A known sensitivity or allergy to any components of the study medication.
* Major congenital or genetic defect.
* Participant's parents not able, available or willing to accept active follow-up by the study staff.
* Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
* History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
* History of any neurologic disorders or seizures.
* Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent.
Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas.

This is a pilot randomized control trial (RCT) to explore the effects of hydrogen rich water on quality of life in patients with high grade gliomas, receiving focal radiation therapy to the brain concurrent with chemotherapy with Temozolomide.

This will be a pilot trial exploring the ability of molecular hydrogen to improve quality of life in patients with high grade gliomas, receiving focal radiation therapy to the brain concurrent with chemotherapy with Temozolomide. Hydrogen has an excellent safety profile, has antioxidant properties and reduces inflammatory events in the tissues. It has been postulated in previous studies that continuous consumption of hydrogen water reduces oxidative stress in the brain by lowering the concentration of the reactive oxygen species, resulting in the improvement of adult neurogenesis or the stimulation of neural proliferation, leading to the prevention of the decline in the learning and memory.

This will be a double blinded, placebo-controlled trial. Eligible and willing subjects will be randomly assigned in a 2:1 ratio to be treated with either hydrogen or placebo, to receive hydrogen or placebo, additionally to all standard-of-care treatments. The treatment with hydrogen or placebo will start the day before chemoradiation therapy starts, and continue for six weeks. The effects of drinking hydrogen water on the quality of life will be assessed using the EORTC QLQ-C30 and the EORTC QLQ-BN20 questionnaires at baseline, at 6 weeks, 6 months, 12 months, 18 months and 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years old or over
* New diagnosis of a malignant glioma (HGG) either by a biopsy or craniotomy
* KPS of at least 70
* Being able to fill out quality of life questionnaire

Exclusion Criteria:

* Other major diseases of the central nervous system, including history of prior brain tumors, Alzheimer's disease, Parkinson's disease, demyelinating disease, inflammatory brain or vascular disease, traumatic encephalopathy, or idiopathic intracranial hypertension, anxiety/depression.
* Pre-existing neurological disability, unable to read or write
* Severe comorbidities likely to result in patient dying within 3 months
* Prior history of head/neck radiation therapy
* Other active cancer or history of other cancer diagnosed within 5 year.
* Inability to safely tolerate the 1500 ml- 2000ml fluid load (po water) associated with study medication\*
* Pregnancy or nursing.
* Treatment with another investigational drug within the last 30 days that may interfere with this study's medications\*
* Hypersensitivity to Temozolomide and or it's active agent- Dacarbazine
Comparison of Adalimumab and Infliximab Treatment of Rheumatoid Arthritis

The purpose of this study is to establish whether RA patients with moderate to severe disease activity with unsustainable response to infliximab 3 mg/kg every 8 weeks have better efficacy with adalimumab 40 mg s.c. eow compared to infliximab 3 mg/kg i.v. every 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* ACR criteria fulfilled,DAS28-3(CRP \> 3.2
* \> 6 months prior treatment with infliximab 3 mg/kg i.v. every 8 week with initial response
* Fading clinical response to infliximab
* Negative pregnancy test (women with childbearing potential)
* Use of reliable method of contraception (women with childbearing potential)
* Informed consent

Exclusion Criteria:

* Age less than 18 years
* Lack of co-operability
* Positive serology for hepatitis B or C
* History of positive HIV status
* History of TB or untreated latent TB
* Histoplasmosis or Listeriosis
* Pregnancy or breastfeeding
* Persistent or recurrent infections
* History of cancer
* Uncontrolled diabetes
* Ischaemic heart disease
* Congestive heart failure (NYHA 3-4)
* Active inflammatory bowel disease
* Recent stroke (within 3 months)
* History of or current inflammatory joint disease other than RA
* Previous diagnosis or signs of central nervous system demyelinating disease
Move in Mind: Program for Reducing Musculoskeletal Pain

The present pilot study will explore the range of mental and physical health benefits associated with a Rolfing®-based intervention program ("Move in Mind"). To assess the effects of this program on pain management and various psychological outcomes, the investigator's study will be offered to individuals with mild chronic musculoskeletal pain (e.g., lower back pain, neck pain, shoulder pain, knee pain, arthritic pain). Shortened from ten to six sessions and adapted to a group setting by Rolfing® instructor Monica Canducci, the intervention will be delivered weekly by Ms. Canducci, who is certified in Rolfing®. The program will target the potential associations of the Move in Mind program with better pain management (primary outcome) as well as increased body awareness and presence, increased well-being, and better stress management (secondary outcomes). Interested participants will be asked to complete a battery of questionnaires and psychometric scales to assess the variables of interest before (baseline) and after their participation in the Move in Mind program (six-week follow-up). A waitlist control group will also be assessed at baseline and follow-up and will then receive the Move in Mind sessions subsequently and also assessed after their participation.


Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* experiencing a type of mild musculoskeletal pain (e.g., pain related to the muscles, ligaments, bones, joints, or nerve compression)

Exclusion Criteria:

* pregnant
* receiving treatment for severe chronic pain
* have had recent concussions or fractures as a result of accidents
Examination of Ventavis (Iloprost) Inhalation Behavior Using the I-Neb AAD System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)

The aim of this study is to examine inhalation behavior in patients enrolled in the German Ventavis patient support program Ventaplus when these patients are switched from Ventavis (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation.

The VENTASWITCH study will be a local, prospective and retrospective, observational, case-crossover study. Data are collected and downloaded from the I-Neb AAD (Adaptive Aerosol Delivery) System. Two data collection periods are planned: period one; data collection from the last 3 months using Ventavis (Iloprost) 10 μg/mL (V10) before the index date of switching to Ventavis (Iloprost) 20 μg/mL (V20) (retrospective part) and period two; data collection for 3 months using V20 from index date (prospective part).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥18 years at time of signing informed consent.
* Patients, diagnosed with group 1 PAH.
* Patients must be enrolled in the German Ventavis patient support program Ventaplus.
* Patients who either already switched from V10 to V20 therapy or who agreed to do so according to their physician's decision.
* Patients must have been on V10 therapy for at least 2 weeks.
* Written informed consent must be obtained.

Exclusion Criteria:

- participation in other clinical or interventional study.