cyrilzakka/clinical-trials huggingface dataset:
Bridging Study for Killed Oral Cholera Vaccine in Ethiopia

This is a randomized, double blind, placebo controlled trial to confirm the safety and determine the immune response of the killed oral cholera vaccine in healthy adults and children in Ethiopia.

This study serves as a bridging trial to evaluate the safety and immunogenicity of a two dose regimen of the WC-OCV (Shanchol®) in Ethiopian population. In order to assess whether the bivalent killed oral cholera vaccine may be used safely among those who are most at risk for cholera, we need to determine the safety and immunogenicity of the killed oral cholera vaccine. The vaccine was evaluated in a large number of human subjects in India Vietnam, and Bangladesh, in which it has demonstrated safety, immunogenicity, and clinical protective efficacy. Though we do not expect the vaccine to act differently in the Ethiopian population, we aim to confirm our presumptive understanding that two doses of WC-OCV is safe and immunogenic in healthy volunteers at one year and above (exclusive of pregnant women). Findings from this study can pave the way for the possible use of the killed whole cell oral cholera vaccine in both endemic and outbreak settings at a larger scale.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female adults aged 18 years and above; and children aged 1 -17 years who is available for follow-up visits and specimen collection.

   * The subject should be able to continue in the study for the next 4 weeks
   * The subject (or parent/guardian) should be willing to provide 3 blood samples
2. For females of reproductive age, non-pregnant (as determined by urine pregnancy test).
3. Written informed consent obtained from the subjects or their parents/guardians, and written assent obtained from children aged 12 - 17 years.
4. Healthy subjects as determined by:

   * Medical history
   * Physical examination
   * Clinical judgment of the investigator

Exclusion Criteria:

1. Ongoing chronic recurring illness which may cause systemic symptoms as judged by the investigating physician.
2. Ongoing acute illness.
3. For females of reproductive age: Pregnancy (or females planning to become pregnant during the study period; as determined by verbal screening)
4. Immunocompromising condition or on chronic systemic steroid therapy
5. Diarrhea (3 or more loose/more watery stools within a 24-hour period) within 6 weeks prior to enrollment
6. Intake of any anti-diarrhea medicine in the past week
7. Abdominal pain or cramps, loss of appetite, nausea, or vomiting in the past 24 hours
8. Temperature ≥38ºC (oral or axillary) warrants deferral of the vaccination pending recovery of the subject
9. Previous hypersensitivity to formaldehyde.
10. Receipt of immunoglobulin or any blood product during the past 3 months
11. Receipt of oral cholera vaccine in the past three years
12. Any potential subject currently participating or who will participate within the next six months in another clinical trial
13. Positive screening urine pregnancy test for females greater than 12 years of age
Indications for Gallbladder Surgery in Gallstone Disease

The aim of the study is to identify patients with gallstone disease that should be operated and those that may potentially be observed. This selection was based on symptoms and clinical presentation. The consequences that may arise for the patient if observation is chosen compared with outcome after cholecystectomy has been markers of outcome.

1. Randomized clinical trial (RCT) of observation versus surgery for uncomplicated gallstone disease
2. RCT of observation versus operation for acute cholecystitis
3. Study of outcome after cholecystectomy in patients from 1. and 2.
4. Study of symptoms in gallstone disease and symptom relief after cholecystectomy
5. Long-term morbidity and mortality, including cancer, after cholecystectomy
6. Long-term follow-up of patients with silent gallstones

Eligibility Criteria:
Inclusion criteria:

* Symptomatic gallstone disease (SGBS):

Episodes of pain in the right subcostal or midline epigastric area lasting more than 30 min, with ultrasonography signs of gallstones.

* Ultrasonographic: echo with an acoustic shadow in a visible gallbladder, or an echo with positional change and size \<3 mm or, alternatively no demonstrable gallbladder but a strong echo with an acoustic shadow in the position of the gallbladder

Exclusion Criteria SGBS:

* Infrequent and/or minimal pain that need only very occasional medication
* Age below 18 or above 80
* Not willing to participate

Inclusion criteria, acute cholecystitis (AC):

* Acute abdominal pain
* Duration of more than 8-12 h
* Tenderness on clinical examination in the upper right quadrant
* Presence of gallbladder stones and signs of inflammation on ultrasonography and in clinical biochemistry data, including an elevated temperature

Exclusion criteria, AC:

* Severe concomitant disease
* Suspected Common Bile Duct stone
* Acalculous cholecystitis
* Localized peritonitis suggesting gallbladder perforation or gangrenous cholecystitis

Inclusion criteria 1983 cohort of patients:

* Participation in a screening study for gallstones in 1983
* Operated for symptomatic gallstone disease in Bergen, Norway in 1983
18348-Human Phototoxicity Test

To determine the phototoxic potential of a topically applied article in human subjects


Eligibility Criteria:
Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis;
* must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
* have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products
A Comparative, Single-Center, Pediatric Taste Test Study of Omnicef Versus Amoxicillin Antibiotic Suspension Medications

To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin oral antibiotic suspension medications in pediatric subjects. It is designed to determine if Omnicef or amoxicillin is preferred to the other with regard to taste or smell.

The Primary Purpose for the study is "Other". Per ClinicalTrials.gov, more information regarding the primary purpose is described here; the primary purpose for the study is to determine whether cefdinir possesses preferred taste and smell characteristics when compared to amoxicillin, a pediatric taste test.

Eligibility Criteria:
Inclusion Criteria:

* Female or male child age 4 through 8 years in good general health.
* Minimum weight of 16.3 kg (36 lb).
* Willing to comply with appropriate instructions provided to complete the study.
* Written informed consent from parent/legal guardian.

Exclusion Criteria:

* Current medical condition, that in the opinion of the Investigator or designee, could interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, etc.).
* History of allergic reaction to cefdinir, prescription (e.g. penicillins or cephalosporins) and/or OTC medications, and/or food products.
* History of significant medical condition (e.g., GI disorders, hematological or bleeding disorders, renal or hepatic diseases).
* Use of any oral medication, vitamins or herbal supplements within 6 hours prior to tasting.
* Temperature \> than 99.2°F.
* Participation in a clinical or marketing research study within the past 3 months.
* Sibling of another subject on the study, or living in the same household as another subject that has participated in a clinical or marketing research study within the past 3 months.
* Family member or close friend employed by an advertising agency, market research company and/or a company that processes or manufacturers medical or health care products.
Zimmer® MotionLoc® in Distal Tibia Fractures

The objective of this observational prospective study is to systematically document the clinical outcomes of Zimmer MotionLoc Screws for Periarticular Locking Plate System applied to distal tibia fracture treatment and confirm safety and performance of the screws.

Primary Endpoint:

* Radiographic \& clinical fracture healing at 3 months post-surgery.

Secondary Endpoints:

* Complications
* Radiologic \& clinical fracture healing at 6 weeks, 3, 6, and 12 months post-surgery.
* Callus size \& distribution at 6 weeks, 3, 6, and 12 months post-surgery.

Radiologic fracture healing is defined as bridging of three of the four cortices as seen on x-ray/CT. Clinical healing will be assessed using the Function Index for Trauma (FIX-IT). The FIX-IT instrument quantifies clinical healing by assessing weight-bearing and fracture site pain on an ordinal scale. It has been initially validated in patients with tibia and femur fractures.

Callus size of the anterior, posterior, and medial aspect will be assessed for each time point using a validated and published computational method.

Eligibility Criteria:
Inclusion Criteria:

* With or without fibula fracture involvement (treated or not treated by osteosynthesis)
* Close or open fractures Gustilo type I
* Unilateral or bilateral fractures
* Patients who are capable of understanding the doctor's explanations, following his instructions and are able to participate in the follow-up program.
* Patients who give written consent to take part in the study by signing the "Patient Consent Form".

Exclusion Criteria:

* Delay of surgery for more than two weeks.
* Open fractures Gustilo type II \& III
* History of infection of the affected extremity
* Non-ambulatory patients
* Planned fixation strategy includes interfragmentary lag screw fixation of non-articular fractures.
* Addition of bone graft, bone graft substitute or bone morphogenetic protein (BMP).
* Immobilization with plaster.
* Likely problems with maintaining follow-up program (e.g. patients with no fixed address, plans to move during course of study)
* Not expected to survive the duration of follow-up program.
* Patients known to be pregnant or breastfeeding.
* Patients who are unwilling or unable to give consent.
Intensive Rehabilitation in Peripheral Arterial Disease With Claudication: Effects of a Treadmill Training With Active Recovery

Rehabilitation is the first intention treatment of peripheral arterial disease (PAD) with claudication. Initially proposed in the sixty's, rehabilitation programs dedicated to patients with PAD have recently been proved effective and defined in many guidelines. Supervised walking training on treadmill is recommended. Usually patients walk up to a mild or moderate pain (evaluated at 3 or 4 on the claudication pain scale; maximum pain =5), then stop until pain completely subsides and walk again .

The Artex study assesses the efficacy of a fractionated mode of training avoiding pain by alternating short sequences of intensive training and active recovery (without rest).

Fractionated mode of training with active recovery has been proved effective in sport training as well as in Cardiac rehabilitation. We hypothesized it might be also interesting in the rehabilitation of patients with a peripheral arterial disease. The active recovery period might magnified the beneficial effect of a short intensive training.

Eligibility Criteria:
Inclusion Criteria:

* Patient (male/female) between 18 and 80 years
* Patient with Fontaine stage II PAD confirmed by clinic, duplex ultrasound and ankle-to-brachial systolic blood pressure index
* Cardiac status compatible with an intensive gait rehabilitation (checked by a consultation with a cardiologist, including interview, clinical examination, electrocardiograph, and effort test on ergocycle).
* Volunteer to take part in the study, having sign the consent form after receiving sufficient information and the information leaflet
* Person affiliated to social security or the recipient of a similar scheme

Not Inclusion Criteria:

* Exercise tolerance limited by other factors than claudication (eg, coronary artery disease, dyspnea, poorly controlled blood pressure
* walking limited by other pathology
* osteoarticular lower limbs pathology
* abdominal aortic aneurysm \> 4 cm
* pseudo-flu-like feverish syndromes in evolution (myocarditis or pericarditis)
* Person deprived of liberty by a legal or administrative decision, person under legal protection
* Person currently participating in a clinical trial or having taken part in a clinical trial in the month preceding inclusion
* Patient presenting with a history of mental or psychiatric illness or any other factor restricting his/her ability to participate in an informed manner and in compliance with the protocol

Exclusion Criteria:

Impossibility to perform protocol whatever reason
Socket Preservation Using Socket Shield Technique Comparison of Socket Preservation Using Socket Shield Technique With Autogenous Dentin Graft Versus Alloplast Graft Material

Alveolar bone resorption and labial bone plate reduction follow teeth extraction due to the deficiency of blood supply, derived from the loss of periodontal ligaments, and hence the socket shield technique with autogenous dentine was introduced to preserve the periodontal ligaments.

this study aim to evaluate of socket preservation using alloplast with socket shield versus Autogenous dentin graft with socket shield through radiographic analysis of alveolar bone dimension change and mean bone density in addition to histological and histomorphometric analysis for the quality of the formed bone.


Eligibility Criteria:
Inclusion Criteria:

* One or more of non-restorable (fractured or decayed) tooth/teeth in the maxillary aesthetic regions (incisors, premolars) in both side
* Intact labial periodontal tissues.
* Ability to read and sign an informed consent form.

Exclusion Criteria:

* A medical history that contraindicates oral surgical treatment (uncontrolled/untreated diabetes mellitus, immunocompromised status, radio/chemotherapy of the oral and maxillofacial region, treatment with oral and/or intravenous amino-bisphosponates).
* Untreated periodontal disease.
* Vertical root fractures on the labial aspect.
* Tooth /teeth with horizontal fractures below bone level.
* Tooth /teeth with external or internal resorptions.
Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.

Study to gather information on the acceptability of a new flavor system with increasing levels of 2, 4, 6 g or higher of the sugar alcohol Mannitol for Polyethylene glycol (PEG) 3350 a drug stimulating bowel movement to pass stool in subjects having infrequent bowel movements. The taste of the various preparations will be measured by use of a rating scale.


Eligibility Criteria:
Male and female subjects, aged 18 years and older, suffering with occasional constipation
Tolerance Study of the Dietary Supplement Valedia

The objectives of this clinical study are to determine the tolerance of dietary supplement Valedia (blend of plant extracts) through the evaluation of several parameters :

* Various blood biological parameters for tolerance (preprandial): blood glucose, insulin, fructosamine, total cholesterol, triglycerides, HDL-cholesterol, LDL-cholesterol, oxidized LDL, us-CRP, creatinine, ASAT, ALAT, gGT, phosphatase alcaline, bilirubine, urea.
* Urinary parameters: urea, creatinine.
* Hemodynamic parameters: heart rate and blood pressure.
* Cardiac function: ECG.
* Weight.


Eligibility Criteria:
Main Inclusion Criteria:

* 25 \<= BMI \< 30 kg.m2

Main Exclusion Criteria:

* ASAT \<= 1,55 microkat/L
* ALAT \<= 1,70 microkat/L
* gGT \<= 2,55 microkat/L
* 55 \<= Creatinine \<= 104 micromol/L (+- 10%)
* Bilirubin \< 17,1 micromol/L (+- 10%)
* 1,7 \<= Urea \<= 8,3 mmol/L (+- 10%)
* us-CRP \<= 5 mg/L (+- 10%)
* 0,70 \<= Fasting glycemia \<= 1,25 g/L (+- 10%)
* HbA1c \<= 6%
* Medications for diabetes and/or dyslipidemia
Effects of Gum Arabic Supplementation in Hemodialysis Patients

Gum Arabic is a naturally produced gummy exudate from Acacia Senegal tree. It's a complex polysaccharide with proven prebiotic properties. Through its effect on intestinal bacteria, it's expected to reduce systemic levels of toxic bacterial metabolites and reduce inflammatory markers.By increasing fecal bacteria mass it's also expected to reduce blood urea level. These changes are potentially beneficial to hemodialysis patients who suffer from disturbed intestinal flora and a chronic inflammatory status. The investigators hypothesize that supplementing the diet of hemodialysis patients with Gum Arabic for four weeks would reduce inflammatory markers, increase total anti-oxidant capacity and reduce blood urea concentration.


Eligibility Criteria:
Inclusion Criteria:

* Adult end-stage renal disease patients maintained on regular hemodialysis

Exclusion Criteria:

* Chronic liver disease
* Malignant condition
* Inflammatory bowel disease
* History of bowel resection
* Long term antibiotic therapy
* Pregnancy or lactation
* Current use of immunosuppressive medication
Epidural Electrical Stimulation to Support Hemodynamic Management in Individuals With Parkinson's Disease

The PD-HemON study aims to evaluate the safety and preliminary efficacy of ARC-IM Therapy (Epidural Electrical Stimulation) to support hemodynamic management in people with typical and atypical Parkinson's Disease, who suffer from orthostatic hypotension.


Eligibility Criteria:
Inclusion Criteria:

1. \> 18 years old
2. Typical or Atypical PD (including but not limited to Multiple System Atrophy, Pure Autonomic Failure, Progressive Supranuclear Palsy)
3. Confirmed orthostatic hypotension with a test for verticalization
4. Confirmed symptomatic orthostatic hypotension that makes daily activities particularly challenging as determined by the study clinicians
5. Must provide and sign the Informed Consent before any study-related procedures
6. Stable medical, physical, and psychological conditions given participant indication as considered by Investigators;
7. Able to understand and interact with the study team in French or English
8. Agrees to comply in good faith with all conditions of the study and to attend all scheduled appointments

Exclusion Criteria:

1. Diseases and conditions that would increase the morbidity and mortality of the implantation surgery
2. The inability to withhold antiplatelet/anticoagulation agents perioperatively
3. History of myocardial infarction or cerebrovascular events within the past 6 months
4. Unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations as determined by the Investigator
5. History or presence of major psychiatric disorders or major neurocognitive disorders as considered by the Investigators in accordance with the treating physician and treating neurologist
6. Major changes in PD treatment planned until the end of the main study phase (such as DBS or dopamine-pump implantation)
7. Inability to follow study procedures.
8. Spinal anatomical abnormalities precluding surgery
9. Presence of any indications requiring frequent MRIs.
10. Current pregnancy or current breastfeeding
11. Lack of effective or acceptable contraception for women of childbearing capacity
12. Intention to become pregnant during the study
13. Unable or unwilling to effectively use the study system or related devices by the participant or caretaker, as determined by the investigator
14. Participation in another interventional study that might confound study endpoint evaluations
15. Enrolment of the investigator, his/her family members, employees, and other dependent persons
Clinical Comparison of Two Daily Disposable Silicone Hydrogel Soft Contact Lens

The objective of this study is to evaluate a new daily disposable silicone hydrogel soft contact lens by comparing to an existing daily disposable soft contact lens.

This study is designed to evaluate the performance of the olifilcon B contact lens to demonstrate substantial equivalence to the narafilcon A for regulatory requirement.

Eligibility Criteria:
Inclusion Criteria:

* Subject should have normal eyes and use no ocular medications
* Subject with -1.00 to -10.00 D myopia, less than 2.00 D astigmatism
* VA correctable to Log MAR 0.1 or better.
* Willing to comply with all study procedures and be available for the duration of the study.
* Provide signed and dated informed consent form.

Exclusion Criteria:

* Subjects have history of allergies that would contraindicate "normal" contact lens wear.
* Subjects have other active ocular or systemic disease such as, but not limited to : anterior uveitis (past or present), glaucoma, Sjögren's syndrome, lupus erythematosus, sclerodermas, keratoconus or type II diabetes.
* Subjects have medications that would contraindicate contact lens wear.
* Currently pregnant (to the best of the subject's knowledge), is lactating or is planning a pregnancy within the next 3 month.
* Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
* Any active participation in another clinical trial within 30 days prior to this study.
* The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
* A known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates or fungal infections.
* A history of papillary conjunctivitis that has interfered with contact lens wear.