cyrilzakka/clinical-trials huggingface dataset:
Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure

Randomized, double-blind, controlled clinical trial to evaluate the effect of parenteral nutrition (PN) supplemented with lipid emulsions containing 0.1-0.2 g omega 3 polyunsaturated fatty acids (n-3 PUFA)/kg body weight/day for 7 days on malondialdehyde (MDA) levels, a marker of lipoperoxidation of reactive species, compared with a control group (without n-3 PUFA) in patients with intestinal failure (IF).

IF is the loss of intestinal function that affects the decrease in the absorption of macronutrients, water, and electrolytes, so it requires intravenous supplementation such as PN and/or intravenous fluids to maintain health and/or growth. IF type II is associated with complex infectious and metabolic complications and patients require PN for weeks or months. Long-term PN use, however, includes the risk of complications, among which a serious one is the intestinal failure-associated liver disease (1). It has been proposed that metabolic endotoxemia (2-3), inflammation (4) and oxidative stress (5) are involved in the development of this intestinal failure-associated liver disease.

Although some studies have reported beneficial effects of n-3 PUFA to prevent and reverse the liver disease associated with IF (6-7), due to its antioxidant (8-10) and anti-inflammatory activity (11-12) and in the modulation of the intestinal microbiota (13), the literature on the use of n-3 PUFA in non-critical patients with IF and PN is limited and the results have not been conclusive.

Therefore, a randomized, double-blind, controlled clinical trial to evaluate the effect of PN supplemented with lipid emulsions containing n-3 PUFA/kg body weight/day for 7 days on oxidative stress (concentrations of MDA), compared with a control group (without n-3 PUFA) will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted in the non-critical areas of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) with a nutritional risk between January 2019 and July 2020 will be considered eligible.
* Patients with recent diagnosis of IF type II (an evolution \>28 days) originate from various gastrointestinal or systemic diseases (short bowel, intestinal fistula, intestinal dysmotility, mechanical obstruction, and extensive small bowel mucosal disease).

Exclusion Criteria:

* Patients with contraindications for PN
* Patients with known allergies to the components of the PN formula
* Severe liver or renal insufficiency
* Uncontrolled diabetes mellitus
* Certain acute and life-threatening conditions
* Immunological diseases (such as autoimmune diseases, human immunodeficiency virus infection, cancer, etc.)
* Those that take immunosuppressant medications
* Severe hemorrhagic disorders
* Pregnant or lactating
Quetiapine Augmentation Versus Clomipramine Augmentation of SSRI for Obsessive-compulsive Disorder Patients

The objective of this trial is to compare in an open trial format the efficacy of association of clomipramine and quetiapine with SSRI after SSRI treatment failed to produce complete remission of obsessive compulsive disorder symptoms.

The objective of this trial wis to compare in an randomized open trial format the efficacy of association of clomipramine at maximum dosage of 75mg per day and quetiapine at maximum dosage of 200mg per day with SSRI after SSRI treatment for 12 weeks failed to produce complete remission of OCD symptoms.

Eligibility Criteria:
Inclusion Criteria:

* primary OCD diagnosis according to DSM IV criteria
* current symptoms were responsible for significant distress
* previous trial of at least 12 weeks with SSRI (being at least 8 weeks at maximum tolerated dosage) failed to produce full remission of OCD symptoms

Exclusion Criteria:

* presence of clinical or neurological diseases that may be worsen by the medications included in treatment protocol
* current substance dependence or abuse,
* current psychotic symptoms
* current suicide risk
* and current pregnancy or intention to get pregnant before the end of the treatment protocol
Standardized Infant NeuroDevelopmental Assessment (SINDA) in 0-24 Months Age in Turkey

This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.

There are developments in the field of diagnosing children with a high risk of developmental disorders such as cerebral palsy (CP), mental problems and autism spectrum disorder in infancy. In particular, in infants experiencing the onset of extrauterine life in the neonatal intensive care unit, the combination of neonatal neuroimaging along with the assessment of general movements results in a highly accurate prediction of CP .

A clinical tool often used in predictions is a neurological examination. Various standard variants are available, such as the Hammersmith Infant Neurological Examination (HINE), Alberta Infant Motor Scale (AIMS).

The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome .This study aims to assess Turkish validity and reliability of Standardized Infant Neurodevelopmental Assessment and to spread its use for evaluation in early rehabilitation in our country.

Eligibility Criteria:
Inclusion Criteria:

* at-risk infants
* discharged from neonatal intensive care unit;
* age between 0 - 24 months old (corrected age for premature infants);
* having a family acceptance for the participation

Exclusion Criteria:

* having congenital anomalies,
* musculoskeletal disorders,
* cyanotic congenital heart disease and
* mechanical dependency
Evaluation of Scalp and Hair Shaft With Biologic Markers in African American and Caucasian Hair

The purpose of this research study is to better understand African American hair and scalp, its biologic appearance and how this relates to African Americans' perceptions of their hair and scalp health. Since most hair studies have looked at Caucasian hair and scalp, we will use a population of Caucasian subjects for comparison in evaluating various hair and scalp parameters.


Eligibility Criteria:
Inclusion Criteria:

* Must be willing to sign informed consent
* Female from the ages of 21-60 years
* Must be willing to have a thorough scalp and hair shaft examination
* Must be willing to discuss hair care regimen currently and in the past
* Must have washed hair at least 48 hours prior to initial study visit
* Pregnant and nursing females will not be allowed in the study; a baseline pregnancy test will be done to exclude pregnancy on females of childbearing potential
* Must be \>6 months (26 weeks) postpartum
* Must have sufficient contrast between scalp skin color and hair color
* Must have hair at least 2 inches long
* May have mild itching and mild scaling of the scalp
* Must be willing to have hair clipped and shaved to 1mm within an approximately 2.5cm test site
* Must be in good stable general health, with no current infections.

Exclusion Criteria:

* May not have sewn-in or glued hair pieces or extensions at the time of the study
* Must not cut hair during the study
* Must not have hair loss beyond what is considered normal in the opinion of the Investigator at the time of the study
* Must not color hair or have other salon-type procedures (relaxer, permanent, highlighting, etc.) performed within 2 weeks of the initial visit
* Must not have any other underlying scalp disorder that could interfere with the test procedures or findings
* Must not have lost ≥10% of body weight within the past 12 months
* Must not have been on a weight reduction program overseen by a physician or nutritionist within the past 12 months
* Has used hair growth products e.g. minoxidil in the past 18 months
* Has undergone a hair transplant or scalp reduction surgery
* Has participated in a hair growth study within the past 15 months
* Is currently participating in another clinical study at this or any other facility
* Is taking, for a chronic condition, any prescription or over the counter medication(s) that in the opinion of the Investigator are likely to affect the hair properties (e.g. immunosuppressive agents, corticosteroids; or chronic use of anti-inflammatory medication)
* Application of any over-the-counter or prescription drug to the scalp on a routine basis within the past 3 months including but not limited to retinoids (e.g. retinal, tretinoin, retinyl palmitate, retinyl acetate, retinyl propionate), topical corticosteroids, benzyl peroxide, or any topical hormone therapy (e.g. Eterna 27)
Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol

The objective of this study is to compare the relative bronchoprotection (at trough) conferred by 2-week chronic dosing with levosalbutamol and racemic salbutamol in mild to moderate asthmatics. Patients will be preselected into two groups on the basis of their beta-2 adrenoreceptor polymorphisms. The investigators will evaluate if this has a differential effect on the bronchoprotection conferred by both formulations of salbutamol, as evidenced by a rebound in airway hyper-responsiveness, in order to determine whether any effect can be explained by the S enantiomer in the racemic formulation.


Eligibility Criteria:
Inclusion Criteria:

1. Mild to moderate stable asthmatics on ≤ 2000μg BDP or equivalent, who are methacholine responsive PC20\< 4 mg/ml
2. \>1dd change in methacholine PC20 after the administration of racemic Salbutamol.
3. Male or female 18-65
4. Informed Consent
5. Ability to comply with the requirements of the protocol

Exclusion Criteria:

1. Severe asthmatics as defined by an FEV1≤ 60% or PEF variability \> 30% or with continual daytime or nocturnal symptoms.
2. The use of oral corticosteroids within the last 3 months.
3. Recent respiratory tract infection (2 months).
4. Significant concomitant respiratory disease such as COPD, CF, ABPA, bronchiectasis and active pulmonary tuberculosis.
5. Any other clinically significant medical condition such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA/ CVA, that may endanger the health or safety of the participant, or jeopardise the protocol.
6. Any significant abnormal laboratory result as deemed by the investigators
7. Pregnancy, planned pregnancy or lactation
8. Known or suspected contra-indication to any of the IMP's
9. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.
COMPArison of Screening Strategies for Active TuBerculosis (COMPASS-TB)

The study is an evaluation of the diagnostic performance of different tests and their association in order to confirm or exclude active tuberculosis.

Background : diagnostic methods to distinguish between latent TB infection (LTBI) and active TB disease remains challenging. Data are scarce concerning the positive predictive value of Current diagnostic approaches, including Interferon-Gamma Release Assay (IGRA) and chest radiography, which is often very low. Computed tomography (CT) scanning, although not recommended by the World Health Organization (WHO) for TB diagnosis, may be of high interest in our high-income low-burden countries. This study assess the performance of the combination of CT scanning and IGRA to diagnose active pulmonary TB and identifies discriminatory CT scan features indicative of active disease.

Methods : A retrospective study was conducted on 580 patients clinically suspected of TB or in contact with bacteriologically confirmed cases (index cases). Patients underwent IGRA testing, thoracic CT scans, and respiratory (or other organs) samples culture. CT scan findings were blindly analyzed, and a composite score combining significant radiological signs with IGRA results was constructed. Diagnostic performance measures, including sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV), were calculated.

Eligibility Criteria:
Inclusion Criteria:

Major patients who received the following examinations at the Montpellier University Hospital for tuberculosis screening (clinical suspicion and/or contact with a person with active tuberculosis):

* Chest X-ray AND
* Chest CT scan AND
* Mycobacteriology examination of respiratory or tissue sample (direct/culture/GenXpert) AND
* IGRA test (Quantiferon)
Percutaneous Repair of Acute Achilles Tendon Rupture With Assistance of Intraoperative Ultrasound

This is a prospective randomized controlled study carried out between May 2016 and December 2020. It included 98 patients presented with acute rupture of Achilles tendon The patients were randomly distributed by closed envelop technique (49 in each group). Group A included those managed with the assistant of an intra-operative ultrasound. Group B included those done without ultrasound assistant

A preoperative prophylactic dose of antibiotic was given intravenously in the form of 2gm of cephalosporin one hour before operation. Under general or regional anesthesia, the patient laid in prone position without a tourniquet and both feet out of the table for easily mobilization of the ankle joint. In group A, an intraoperative ultrasound was done by a radiologist before the repair for identification the course of sural nerve and outline the medial and lateral edges of torn tendon. Then ultrasound was repeated after repair for confirmation of adequate contact of both stumps and satisfactory strength of the repair by visualization of the tendon with passive motion of the ankle. For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al. This technique depends on the leg length for location the point where the nerve crosses the lateral edge of the tendon. The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between. The technique of repair was standardized for all patients in both groups. We used the technique described by Maffulli et al

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 50 years
* acute ( not more than two weeks) closed complete injury
* injury of Achilles tendon in zone 2 (the area between 3 and 6 cm from the insertion) according to Langergran and Lindholm

Exclusion Criteria:

* incomplete injury
* recurrent injury
* associated fracture ankle or foot
* previous history of local corticosteroids injection
* patients with neurovascular problem (e.g. diabetic, autoimmune ...etc), smoking, and alcoholics
A Study of TQ-B3101 in Subjects With Relapsed or Refractory Anaplastic Large Cell Lymphoma (ALCL)

The objective of this study is to evaluate efficacy and safety of TQ-B3101 in subjects with relapsed/refractory anaplastic large cell lymphoma (ALCL) .


Eligibility Criteria:
Inclusion Criteria:

-1.Female or male, 10 years and older. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2. 3.Histologically or cytologically confirmed ALK positive relapsed or refractory Anaplastic Large Cell Lymphoma.

4.At least one measurable lesion. 5.Life expectancy ≥ 3 months. 6.Adequate organ system function. 7.Understood and signed an informed consent form.

Exclusion Criteria:

* 1.Primary cutaneous anaplastic large cell lymphoma. 2.Other malignancies occurred within 5 years, with exception of cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder tumors.

  3.Has received ALK inhibitor. 4.Has received an allogeneic stem cell transplant. 5.Has received autologous stem cell transplant within 12 weeks before the first administration.

  6.Has received other anti-tumor medications within 4 weeks of the first administration.

  7.Has received major surgery within 4 weeks before the first administration. 8.Has received any curative radiotherapy or minor surgery within 2 weeks before the first administration.

  9.Has received palliative radiation therapy within 2 days before the first administration.

  10.Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

  11.Has uncontrollable congestive heart failure. 12.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Safety and Effectiveness Clinical Evaluation of Injectable Medical Devices Viscol

Evaluation of safety and performance of HA based injectable device for skin quality improvement

The primary objective is to evaluate the effectiveness of the device used one month (M1) after treatment using clinical evaluation of the global aesthetic improvement (GAIS) rated by an independent investigator.

The secondary objectives of the study are to collect data on:

* the effectiveness four months (M4) after treatment.
* the effectiveness on the improvement of facial skin quality by objective measurements of skin biomechanical parameters using Cutometer® and skin hydration using Moisturemeter®.
* subject's satisfaction and subject's opinion on aesthetic improvement.
* the injector's satisfaction on the injection quality.
* the safety using clinical evaluation of the Injection Site Reactions (ISR).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy Subject.
2. Sex: male or female.
3. Age: between 35 and 70 years.
4. Subject seeking an improvement for HA skin quality improvement product.
5. Subject with BMI \<30.
6. Subject whose weight did not fluctuate in the last 6 months and who agrees to keep a stable weight during the study.
7. Subject having given his/her free, express, and informed consent.
8. Subject psychologically able to understand the information related to the study, and to give their written informed consent.
9. Subject registered with a social security scheme.
10. Women of childbearing potential should use a contraceptive method considered effective since at least 12 weeks and throughout the study

Exclusion Criteria:

In terms of population

1. Pregnant or nursing woman or planning a pregnancy during the study.
2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
3. Subject in a social or sanitary establishment.
4. Subject suspected to be non-compliant according to the investigator's judgment.
5. Subject having received a total of 6.000 euros as compensations for their participation in clinical research in the last 12 months, including their participation in the present study.
6. Subject enrolled in another study or whose non-enrollment period is not over.
7. Subject with scar(s), mole(s), hair or any other lesion on the studied zones which might interfere with the evaluation (tattoo, permanent make-up...). In terms of associated pathology
8. Subject suffering from a severe or progressive disease or any other pathology that may interfere with the evaluation of the study results and/or subject safety.
9. Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
10. Subject suffering from active disease such as inflammation, infection, tumours, inflammatory and/or infectious cutaneous disorders (herpes, acne, rosacea, porphyria ...) in the 6 months before screening visit.
11. Subject with a history of streptococcal disease or an active streptococcus infection.
12. Subject prone to develop inflammatory skin conditions or having tendency to bleeding disorders
cTACE or DEB-TACE+HAIC Combined With Regorafenib ± Anti-PD1 Antibody for uHCC

explore the effectiveness and safety of conventional transarterial chemoembolization (cTACE) or transarterial chemoembolization (DEB-TACE) plus hepatic arterial Infusion chemotherapy (HAIC) combined with regorafenib and anti-PD-1 antibody or not for unresected hepatocellular carcinoma (uHCC)

This is a non-randomized, open, single-arm clinical study. Patients receive cTACE/DEB-TACE+HAIC treatment( 6-8 weeks as a cycle) and regorafenib and anti-PD1 antibody or not until the disease progresses, intolerable toxicity occurs, the patient is lost to follow-up or death, or situations other judged by researchers which treatment should be stopped.

Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate and sign the informed consent in writing;
2. Age: 18-75 years old;
3. No gender limit;
4. Unresectable hepatocellular carcinoma with clear pathological diagnosis or clinical diagnosis;
5. Unresectable hepatocellular carcinoma patients who failed first-line treatment (including but not limited to sorafenib, lenvatinib, atezolizumab combined with bevacizumab, etc.);
6. At least one measurable lesion (according to mRECIST criteria) imaging diagnosis time ≤ 21 days from selection;
7. Child-pugh grade A-B7 grade
8. The expected survival period is ≥3 months;
9. General physical condition (ECOG) 0-2;
10. Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥9 g/dL, white blood cells ≥3.0×10\^9/L, neutrophils ≥1.5x 10\^9/L, platelets ≥80x 10\^9/L; liver and kidney functions are normal; (Within 14 days): TBIL≤1.5 times the upper limit of normal; ALT and AST≤5 times the upper limit of normal; creatinine≤1.5 times the upper limit of normal; INR≤1.7 or prolonged PT≤4s.

Exclusion Criteria:

1. Those who are currently receiving other effective treatments;
2. Patients who have received regorafenib in the past;
3. Patients who have participated in other clinical trials within 4 weeks before enrollment;
4. Unable to cooperate with cTACE and HAIC treatment;
5. Patients with primary malignant tumors other than hepatocellular carcinoma at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
6. Clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or a history of myocardial infarction within the past 1 year;
7. Neurological or mental abnormalities that affect cognitive ability, including central nervous system transfer;
8. There were active serious clinical infections (\>grade 2 NCI-CTCAE version 4.0), including active tuberculosis within 14 days before enrollment;
9. Known or self-reported HIV infection;
10. Uncontrolled systemic diseases, such as poorly controlled diabetes;
11. Known to have hypersensitivity or allergic reactions to any component of the study drug;
12. Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding