cyrilzakka/clinical-trials huggingface dataset:
In Vivo Biomechanical Analysis of the Practitioner's Motion During a Peripheral Venous Catheter Insertion

The aim of this study is to analyze the palpation and perforation motion performed by the practitioner during the insertion of a catheter while measuring the loads applied on the skin and the veins.

These experimental measures will be used for the design of a more realistic peripheral venous catheter insertion simulator in order to better prepare healthcare students for their first in vivo venous puncture.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult volunteer
* Aged between 18-25 yo or 60-75 yo
* IBM between 18,5-25 or superior or equal to 30
* Cognitive level compatible with oral communication, respect of safety instructions and understanding of realized acts
* Signed the study agreement

Exclusion Criteria:

* Individuals displaying coagulation disorders
* Individuals displaying skin lesions, scars or areteriovenous fistula on the ventral side of the forearm
* Individuals displaying a high infection risk
* Women that have been subject to a lymph node dissection on a malignant breast tumor
* Individuals not able to express their consent
* Individuals having a hierarchical link with the persons conducting this study
* Individuals currently participating to another research which includes an exclusion period
MK0767 in Type 2 Diabetes (0767-012)

This is a clinical trial in patients with Type 2 Diabetes to test the safety of MK0767. This study will also see how effective MK0767 is in lowering markers of glucose metabolism and improving the lipid profile and non-HDL cholesterol when compared with placebo and pioglitazone.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus patients between the ages of 21 and 75 inclusive
* Patient is willing to discontinue current therapy for the duration of the study
* Patient is not a heavy drinker

Exclusion Criteria:

* Patient has a history of Type 1 diabetes and/or ketoacidosis
* Patient has severe diabetic retinopathy, or nephropathy, or neuropath
* Patient has has anti-hyperglycemic therapy including insulin, or rosiglitazone and pioglitazone or 2 or more oral agents in combination within 8 weeks prior to visit 1
* Patient has a history of, allergy to, intolerance or hypersensitive to troglitazone, rosiglitazone, or pioglitazone including history of elevated liver function test, jaundice, or hepatotoxicity associated with these treatments
Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair for Anterior Rectocele.

This study aims to compare the effect of laparoscopic ventral mesh rectopexy versus trans vaginal repair in management of anterior rectocele in females regarding functional outcomes.

Rectocele is the protrusion of the anterior wall of the rectum into the vaginal lumen through the rectovaginal fascia and posterior vaginal wall. Symptomatic rectocele affects postmenopausal women and causes obstructed defecation Significant rectal emptying difficulties, straining at defecation, manually assisted defecation, the need for perineal or vaginal digitation, and local symptoms such as vaginal bulging and pelvic heaviness in 30-70% of cases have been described as symptoms of rectocele .

Constipation can be managed with dietary measures, laxatives, and biofeedback training , which can be beneficial for patients with modest symptoms. Surgical treatment is recommended if conservative treatment fails to alleviate symptoms . However, some patients may be left with constipation, fecal incontinence, incomplete bowel evacuation, or sexual dysfunction despite the correction of the anatomical defect. The selection of patients for surgical intervention for symptomatic rectocele remains a matter of debate.

There is still a controversy between abdominal approaches and the transanal, transperineal, and transvaginal approaches as the optimal surgical approach to treat complex rectocele. While the latter is preferred by gynecologists, the former has increased in popularity among colorectal surgeons, aided in part by the growing interest in minimally invasive surgery.

This study aimed to evaluate the outcome of LVMR in comparison with TVR of anterior rectocele regarding the improvement in constipation score and sexual-related quality of life, surgical outcomes and postoperative complications.

Eligibility Criteria:
Inclusion Criteria:

* Female patients aged between 30 and 60 years, presented with symptomatic rectocele with failed conservative treatments.
* anterior rectocele larger than 3 cm in size with retention of the contrast in the rectocele on defecography.
* excessive straining, sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia.

Exclusion Criteria:

* significant urinary manifestations due to anterior vaginal wall prolapse.
* patients with recurrent rectocele
* complete external rectal prolapse
* isolated anismus
* connective tissue disease
* patients with slow-transit constipation
* fecal incontinence (FI), or abnormal thyroid function.
Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants

The purpose of this study is to determine the effect of zinc in acute watery diarrhea in children. The investigators will evaluate the effect of product versus placebo.

Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, today exist strong evidence of beneficial effect of use of zinc in acute diarrhea in children over 6 months. but there are not enough clinical trials to show this beneficial effect on children under 6 months.

Objectives: To evaluate the effect of zinc in the treatment of children under 6 months age with acute diarrhea.

Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive zinc plus oral rehydration and the other one will receive placebo plus oral rehydration; the parameters of evaluation are going to be the duration of diarrheal episode, number of diarrhea stools by day, weight of stool, nutritional state.

Eligibility Criteria:
Inclusion Criteria:

* all acute diarrhea

Exclusion Criteria:

* Severe malnourishment
* Severe dehydration
* Systemic infections
* coinfections
A Phase 2 Study to Evaluate Safety and Efficacy of AMB-05X in Subjects With Idiopathic Pulmonary Fibrosis

AMB-053-01 is a randomized, placebo controlled, multicenter study which will enroll approximately 36 subjects ages 40 and older with IPF for 6 doses over a 24-week dosing period.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥40 years old.
2. History of confirmed diagnosis of IPF
3. Chest HRCT at Screening
4. Subjects who are either:

   * Not being treated with approved IPF therapies (i.e., nintedanib or pirfenidone) or
   * Being treated with approved IPF therapies (i.e., nintedanib or pirfenidone)
5. Has FVC ≥45% predicted of normal AND DLCO ≥25% and ≤90% predicted
6. Has a FEV1/FVC ratio (Tiffeneau-Pinelli Index) ≥ 0.70
7. Has adequate hematologic, hepatic, and renal function

Exclusion Criteria:

1. Prior investigational drug use within 30 days or 5 half-lives
2. Presence of emphysema exceeding the extent of fibrosis
3. Active or anticipated need for lung transplant
4. Treatment with prednisone
5. Active cancer
6. Active or chronic infection with HCV, HBV, or HIV
7. Known active tuberculosis
8. History of or current immunosuppressive condition
9. IPF exacerbation within 12 weeks
10. Lower respiratory-tract infection requiring antibiotic therapy
11. Smoking
12. Other forms of interstitial lung disease
13. History of lung volume reduction surgery or lung transplant
14. Contraindications for forced expiratory maneuvers during spirometry
15. Unstable cardiac or pulmonary disease (other than IPF)
16. Fridericia-corrected QT interval (QTcF) ≥ 450 ms (men) or ≥ 470 ms (women)
17. History of drug or alcohol abuse -
Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors

Checkpoint inhibitor such as anti-CTLA-4 and anti-PD-1 are known to block inhibitory signals and increase the immune antimutoral response. Nivolumab and Ipilimumab association is considered as a more efficient immunotherapy to treat advanced melanoma. This combined immunotherapy is also responsible of severe immunes toxicyties. Identification of predictives biomarqueurs remains a challenge to predict the balance between tolerability and efficency. Previous data showed that advanced melanoma patient had lower level of Th1 cytokines that predict a less efficient immune system than healthy donors. The second point was that high level of Th1 and Th17 cytokines were correlate to a better tumor response. The last point was that patients with severe immune toxicity showed an increase of IL-6 and IL17a production. The investigators would like to identify the predictive values of Th1, Th2 and Th17 at the begining and during the combined immunotherapy and correlate these cytokines levels secretions to a potential efficient tumor response or to the emergence of induced immunes toxicities. This study is an original approach using functionnal test to predict the balance between efficienty and tolerability.


Eligibility Criteria:
Inclusion

* persone of major age,
* advanced melanoma confirmed,
* RECIST 1.1 disease,
* first line treatment

Exclusion Criteria:

* occular and mucosal melanoma,
* previous checkpoint inhibitor treatment,
* active brain metastasis,
* concomitant immunosuppressive treatment
Mini-autogenous Skin Grafts With Skin Homografts Versus Autogenous Skin Graft for Covering Post Burn Wounds in Children

A prospective study comparing the use of mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.

A prospective study comparing the use of mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children so that the patient can continue on his/her normal life early with less deformities

Eligibility Criteria:
Inclusion Criteria:

* This study will include children (3-12) years old with (10-30) % body surface area burns, admitted to Assuit university hospital burn unit.
* The raw areas in both upper and lower limbs will be the site of the study.

Exclusion Criteria:

* Patients younger than 3 years old.
* Patients with burns more than 30% of total body surface area.
* Patients with medical or mental diseases.
CANDIS-II: Evaluation of the Cognitive-behavioral Treatment Programme CANDIS

The purpose of this study is to evaluate the effectiveness of the cognitive-behavioral treatment program CANDIS among n=450 patients with cannabis use disorders in a mulicenter randomized-controlled clinical trial (n=11 outpatient treatment centers).


Eligibility Criteria:
Inclusion Criteria:

* motivation to change cannabis use
* age 16 or older
* current (12 mth) regular cannabis use (at least 2 days a week)
* informed consent to the study procedures and assessments

Exclusion Criteria:

* current alcohol or any illicit drug dependence syndrome according to DSM-IV other than due to cannabis
* lifetime history of any psychotic disorder
* current severe episode of Major depression
* current panic-agoraphobic disorder (severe)
* severe learning disability, brain damage or pervasive developmental disorder
* currently acute suicidality
* not fluent in german language
* any other current treatment for cannabis use disorders
Peanut Oral Induction Tolerance in Peanut's Allergic Teenagers

The primary purpose of the protocol is to evaluate the efficacy of a protocol for induction of tolerance to peanut ingestion increasing doses. The secondary purpose is to determine the interest of a prolonged maintenance therapy

Prospective randomized double blind, placebo controlled, protocol in two phases: 1/ active treatment versus placebo for induction phase; 2/ long versus short maintenance

Eligibility Criteria:
Inclusion Criteria:

* Adolescents between 12 and 18 years
* Clinical History of allergic manifestation within one hour of ingestion of peanuts or Double-Blind, Placebo-Controlled Food Challenges (DBPCFCs) peanut positive below the threshold of 2 grams
* Bad reaction peanut demonstrated by positive Patch Test (PT ≥ 3 mm above the negative control) and specific IgE f13\> 12 IU / mL and / or rAra h2\> 5.8 IU / mL
* Previous follow at least 1 year

Exclusion Criteria:

* Lack of response during the initial DBPCFCs to the cumulative dose of 2 grams of peanut or instant dose of 1 gram of peanut
* Uncontrolled asthma and / or severe over the previous year
* Atopic dermatitis uncontrolled
* Initial severe anaphylaxis requiring hospitalization in intensive care
* Presence of a major allergy with anaphylaxis at another allergen risk (milk, egg, nuts, or other)
* Home away from a center could support a severe reaction in emergency
* Lack of motivation and understanding of parents and / or child
* Incapacity

  * to establish a daily logbook of clinical monitoring
  * to support severe reaction after eating peanut
  * to follow a regular peanut ingestion protocol
Bioavailability Study of Enoxaparin Sodium Chemi and Clexane s.c.

* The primary objective of the trial is to assess the single-dose relative bioavailability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by subcutaneous (s.c.) injection, under fasting conditions in healthy volunteers.
* The secondary objective of the trial is to assess safety and tolerability of Chemi Enoxaparin (80 mg/0.8 mL) and Clexane® (80 mg/0.8 mL) administered by s.c. injection, under fasting conditions in healthy volunteers.

This is an open-label, randomised, single-dose, 2-way crossover study to determine the comparative bioavailability of enoxaparin sodium from the Chemi Enoxaparin s.c. (80 mg/0.8mL) with that from the reference IMP, Clexane® s.c. (80 mg/0.8mL), following single dose administration in healthy male and female subjects.

Each subject received each treatment over two separate treatment periods under fasting conditions. Each dosing day for male subjects will be separated by a washout period of at least 7 days. The study comprised a pre-study screen (within 14 days of the first dose), followed by 2 Treatment Periods (1 and 2). During each treatment period, subjects will reside at Simbec from the evening before dosing (Day 1), until at least 36 h post dose (evening of Day 2). On admission (Day -1), subjects will provide a urine sample for a drugs of abuse screen; this sample will also be tested to confirm a negative pregnancy result in female volunteers.

A single dose of the randomised treatment will be given on the morning of Day 1 following an overnight fast and blood PK/PD samples collected from pre-dose up to 36 h post dose (14 samples). Safety will also be evaluated at specified times throughout the study.

The post study visit will be conducted on Day 2 (36 h post-dose) of Treatment Period 2.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female volunteer between 18 and 55 years of age.
* Subject with a BMI of 18-30 (Body Mass Index = Body weight (kg) / \[Height (m)\]2)
* Subject with no clinically significant abnormal serum biochemistry, haematology, coagulation factors and urine examination values within 14 days of the first dose.
* Subject with no clinically significant abnormalities in 12-lead electrocardiogram (ECG) and vital signs determined within 14 days of the first dose.
* Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (HbsAg) and hepatitis C virus antibody (HCV) results.

Exclusion Criteria:

* Subject with hypersensitivity or idiosyncratic reaction to enoxaparin and/or low molecular weight heparins, and/or pork products.
* Subject with a relevant history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease. Or with history or presence of alcoholism or drug abuse;
* Subject with clinically relevant abnormal physical findings or clinically relevant abnormal laboratory values indicative of physical illness;
* Female subject who is pregnant or lactating
* Female subject with weight \< 45 kg or male subject with weight \< 57 kg.
The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications

In this study, eligible subjects were randomly assigned to the experimental or control group through randomization (1:1). Under the guidance of electrocardiographic Doppler ultrasound guided puncture and catheterization (EDUG) technology, the tunnel puncture method was compared with the conventional puncture method. The two groups of patients were observed and evaluated intraoperative and postoperative 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, and 90 ± 10 days 120 ± 10 days (if any) and the occurrence of complications during extubation or unplanned extubation at the end of treatment, comparing cases in the north and south, as well as complications related to different catheterization methods


Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥ 18 years old;
* Patients who follow medical advice and require PICC catheterization;
* Patients who have not participated in other clinical studies;
* Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up;
* There are no serious cardiovascular diseases, such as atrial fibrillation, pulmonary heart disease, and other P-wave abnormalities before catheterization, as well as severe heart conduction block

Exclusion Criteria:

* Known allergies to catheter materials;
* There is a history of infection, injury, and radiation therapy at the puncture site;
* The puncture site has a history of venous thrombosis or surgery;
* Severe abnormal coagulation function;
* Superior vena cava compression syndrome;
* Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;
* Heart pacemaker and arteriovenous fistula on the same side of the limb;
* Patients or patients' family members refuse to sign the informed consent form.
Antithymocyte Globulin and Cyclosporine in Treating Low Risk Patients With Myelodysplastic Syndrome

The different mechanisms of action between Antithymocyte globulin and cyclosporine can improve the effectivity when both are used in combination in patients with myelodysplastic syndrome.

Patients are treated with:

Antithymocyte globulin (Timoglobulin SangStat)

* 2,5 mg/kg/day IV over 8 hours on days 1-4
* Total dose: 10 mg/kg
* Calculated dose adjusted to ideal weight
* Especial considerations:

Paracetamol 1 gr (oral or IV) Dexclorfeniramine 5 mg IV Methylprednisolone 1 mg/kg IV 30 minutes before Timoglobulin and repeat if necessary at 4 hours - Platelet transfusion if platelet count is \< 50 x 109/L

Cyclosporine (Sandimmun Neoral)

-2,5 mg/kg/12 h over 3 months

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of low or intermediate risk myelodysplastic syndrome (MDS) (or high risk patient not eligible to intensive chemotherapy or for bone marrow transplantation), excluding chronic myelomonocytic leukemia
* At less one of two following conditions:
* Transfusion dependence: 1)Packed red blood cell transfusions greater than 2 times; 2)Untransfused hemoglobin level no greater than 10 g/dL; 3)Platelet transfusions greater than 1 time
* Infection grade III or IV secondary to neutropenia
* ECOG \< or = 2

Exclusion Criteria:

* Chronic myelomonocytic leukemia
* Creatinine greater than 2 mg/dl
* Bilirubin greater than 2.5 mg/dl
* History of heart failure
* History of allergy to rabbit proteins
Table to Tablet (T2T): A Novel Intervention Framework for Children With Speech Sound Disorders

The primary aim of this study is to develop software as a tool in speech and language therapy for the treatment of children (Portuguese and English) with phonologically based Speech Sound Disorders (SSD). Further, this project aims to test the effectiveness of this approach with two groups of preschool and school aged children with phonologically based SSD, with one group consisting of European Portuguese (EP) speakers and one group of British English (BE) speakers. Performance across the two groups will be compared. The total duration of the project will be 30 month.

The Table to Tablet (T2T) project aims to develop software as a tool in speech and language therapy for the treatment of children (Portuguese and English) with phonologically based Speech Sound Disorders (SSD). Further, this project aims to test the effectiveness of this approach with two groups of children aged between 3 years and 6 months and 6 years and 6 months with phonologically based Speech Sound Disorders (SSD).

One group consists of European Portuguese (EP) speakers and one group of British English (BE) speakers. Each group should include 20 children with the referred criteria and the performance across the two groups will be compared.

The total duration of the project will be 30 month (software development over the first 12 months and an intervention study during following 18 months).

The T2T team includes 3 Speech and Language Therapists and 3 engineers/researchers plus a designer that will develop the T2T material.

Eligibility Criteria:
Inclusion Criteria:

* Diagnose of Phonologically based Speech and Sound Disorder;
* Portuguese as native language;
* Audition of 20 decibels (dB) or lower in the frequencies 500, 1000, 2000 and 4000;
* Normal non-verbal ability (NVIQ) according to age;
* Receptive language skills within normal limits.

Exclusion Criteria:

* Diagnose of childhood apraxia of speech;
* Structural or functional oral alterations
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients

The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alpha-2a and ribavirin as part of their treatment.

This is a randomized, double-blind (neither physician nor participants know the name of the assigned drug), placebo-controlled study of TMC435 in participants who are infected with genotype 1 hepatitis C virus (HCV), who have never received treatment for HCV infection before. Participants in this study will also receive two other drugs for their HCV infection called peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV). The purpose of the study is to investigate if TMC435 is superior to placebo in reducing plasma levels of HCV ribonucleic acid (RNA) to an undetectable level 12 weeks after the end of treatment. For the first 12 weeks, participants will take either TMC435 or placebo, plus PegIFNα-2a and RBV. For the next 12 weeks, participants will take PegIFN alpha-2a and RBV only. After that, some participants will continue to take PegIFN alpha-2a and RBV for up to 24 additional weeks and some will stop taking PegIFN alpha-2a and RBV depending on response-guided treatment criteria. The study doctor will inform each participant about how to take their study medication and when they should stop taking it. After a participant stops taking study medication, they will continue to come to the doctor's office for study visits until a total of 72 weeks after they enroll in the study. The total duration of the study is 78 weeks (including screening). Participants will be monitored for safety throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Genotype 1 hepatitis C infection (confirmed at screening)
* Patient has not received any prior treatment for hepatitis C
* Patient must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
* Must agree to use 2 forms of effective contraception throughout study (both males and females)

Exclusion Criteria:

* Infection with HIV or non genotype 1 hepatitis C
* Liver disease not related to hepatitic C infection
* Hepatic decompensation
* Significant laboratory abnormalities or other active diseases
* Pregnant or planning to become pregnant