cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients

In Dermatology, assessment of people of color remains underrepresented in RCTs (\<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in mild acne and isotretinoin in severe acne. In darker skin type patients, i.e., Fitzpatrick phototypes IV-VI, acne-related pigmentation (ARP) occurs in 65% of cases which reflects either per- or post-inflammatory hyperpigmentation. Whatever is the mechanism, ARP (number, size, importance of dyschromia) impacts the quality of life in such patients. In moderate acne, treatment is based on oral antibiotics for 3 months, i.e., doxycycline or lymecycline, with topical treatment like tretinoin targeting comedons (and potentially ARP). However, oral antibiotics first-line were developed in white skin patients only and never showed its efficacy in ARP. Moreover, doxycycline could be associated with new-onset hyperpigmentation in acne patients. Isotretinoin -acting on the sebaceous gland and therefore the most effective drug in acne- is only prescribed after failure of antibiotics according to the guidelines.The main objective: To assess the superiority at M6 of a treatment of moderate facial acne in skin of color patients with oral isotretinoin in first line compared to the current standard of care on the severity of ARP.Multicenter randomized controlled trial - open study. The number of subjects required for the trial = 420


Eligibility Criteria:
Inclusion Criteria:

* Women and men between 13 and 30-year-old
* Skin type IV, V and VI according to Fitzpatrick skin types
* Moderate acne as defined by the French Society of Dermatology recommendations based on ECLA grading https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf)
* Patients must have a cell phone able to take selfies pictures with a minimum definition of 5Mb.
* Signed informed consent
* Affiliation to French social coverage.

Exclusion Criteria:

* Mild and severe acne (ECLA grading : French recommendations) (https://document.sfdermato.org/groupe/centre-de-preuves/label-recommandations-acne-post-college.pdf)
* Past cure of oral isotretinoin
* Past cure of systemic antibiotics for acne in the last 6 months
* Phototype I-III patients
* Abnormal hemogram, liver enzyme, cholesterol, triglycerides at baseline
* Pregnancy: female patient of childbearing potential will undergo a pregnancy test (plasmatic β-hCG)
* Breast-feeding patients
* Refusal of effective contraception for women
* Contra-indications to oral isotretinoin, doxycycline, lymecycline, topical adapalene/tretinoin
* Vulnerable people: adult under guardianship or deprived of freedom
Investigation of the Cylex® ImmuKnow® Assay

Currently, there is no accurate way of predicting the occurrence of Graft vs Host Disease (GvHD) or infection. The purpose of this study is to analyze blood with the ImmuKnow® Assay to see if doctors can detect which patients are at risk for GvHD and for getting an infection before they occur.


Eligibility Criteria:
Inclusion Criteria:

Patients who are undergoing allogeneic HSCT using a myeloablative preparative regimen for any of the following disorders are eligible:

1. Acute leukemia
2. Non-Hodgkin's Lymphoma
3. Chronic lymphocytic leukemia
4. Hodgkin's disease
5. Multiple myeloma
6. Myelodysplastic Syndromes
7. Myeloproliferative Disorders
8. Aplastic Anemia
9. Chronic myelogenous leukemia
How Diabetic Patient Are Taken Care in Cardiology Service Actually?

Care of the diabetes is multidisciplinary with the involvment either private and hospital specialist


Eligibility Criteria:
Inclusion Criteria:

* evey patient admitted in cardiology department more than 24 hours
* 18 years old and above
* accepted to participate
* patient treated by insuline and/or with oral antidiabetic treatment
* Type 2 diabetes

Exclusion Criteria:

* Type 1 diabetes
* patient admitted for angiography
* iatrogenic hyperglycaemia
Esophageal Motility in Reflux Induced Cough

To determine whether contraction abnormalities in the esophagus plays a role in gastroesophageal reflux induced cough, and thus cough severity in patients with chronic cough.


Eligibility Criteria:
Inclusion criteria:

1. Adult patients (ages 18-75 years old)
2. Cough for more than 8 weeks
3. Additional clinical evaluation of cough including a complete pulmonary function test with methacholine challenge and a high resolution CT scan of the chest.
4. Ability to understand the purpose and nature of the study
5. Willingness to participate and provide consent form

Exclusion criteria:

1. Actively smoke in the preceding 6 months.
2. Recent respiratory tract infection (\<4 weeks).
3. Drink above the recommended safe alcohol limit (21 units per week).
4. History of respiratory or gastrointestinal malignancies.
5. Previous gastrointestinal surgery (excluding minor surgeries, such as cholecystectomy, appendectomy).
6. Subjects with established and significant cardiac, pulmonary, or neurological disorders as deemed by the clinician or study personnel
7. Use of angiotensin converting enzyme inhibitors
8. Use of H2 blockers or proton pump inhibitors in the seven days prior to reflux testing (impedance/pH), or inability to withhold such medications for the duration of the study
9. Women of childbearing potential, using adequate birth control. Adequate birth control includes: (i) hormonal methods, such as birth control pills, patches, injections, vaginal ring, or implants; (ii) barrier methods (such as, a condom or diaphragm) used with a spermicide (a foam, cream, or gel that kills sperm); (iii) intrauterine device (IUD); or (iv) abstinence (no sex). Adequate birth control must be maintained for the duration of the study. Women not using adequate birth control will be excluded from the study, as funding for the pregnancy tests was not included in the small grant awarded for this study.
10. Nursing mothers will be excluded.
11. Persons with allergies to citrus will be excluded.
12. Inability to understand the purpose and nature of the study
13. Unwillingness to participate and provide consent form
A Study of the Response to AG-86893 in Patients With Pterygium Hyperemia

A pterygium is a wing-shaped, benign tissue growth which forms on the surface of the conjunctiva and grows towards the cornea. It can eventually lead to vision impairment. The precise cause of pterygium formation is unknown but new blood vessel growth and fibroblastic structures are characteristics of the disease. AG-86893 is an eye drop being developed to treat hyperemia (redness) and growth of the pterygium.

Hypothesis

1. AG-86893 dosed three times daily for 28 consecutive days has an acceptable safety profile as measured by the incidence and severity of adverse events (AEs) compared with vehicle
2. At least 1 concentration of AG-86893 is effective, as measured by the mean change from baseline in conjunctival hyperemia (redness), compared with vehicle


Eligibility Criteria:
Inclusion Criteria:

* Good health with no clinically significant findings based on the medical history, electrocardiogram, vital signs, blood chemistry, hematology, and urinalysis findings, as determined by the investigator
* Females of childbearing potential must have a negative pregnancy test at baseline and must be on established, adequate contraception and males must use condoms if their partner is of childbearing potential and their female partner should also use an additional effective means of contraception, or they must agree to abstain from sexual intercourse with a female partner for the duration of the study; contraception should be continued for 3 months after the last dose.
* Presence of pterygium with associated conjunctival hyperemia (redness) of grade ≥2 as assessed by a central reading center.

Exclusion Criteria:

* History or presence of any ocular diseases other than pterygium or its sequelae (after-effects), including neoplasia (uncontrolled overgrowth)
* Diagnosis of ocular hypertension or glaucoma requiring use of intraocular pressure-lowering medication
* Use of contact lenses during the study in the study eye
* History or evidence of ocular surgeries in the study eye at any time
* History of liver dysfunction or current abnormal liver enzymes
* Pregnancy, plans for pregnancy, or breastfeeding during the study
Neural and Metabolic Factors in Carbohydrate Reward

Dietary factors contributed to nearly 50% of all cardiometabolic deaths in the US in 2012, making it one of the leading causes of preventable death in the US, second only to tobacco use. Human diets and food choices can't help but be influenced by the ubiquitous availability of processed foods of high-energy density and low nutrient content, consumption of which can lead to obesity, type II diabetes, heart disease, and other types of metabolic dysfunction. Surprisingly, food reinforcement does not rely on perceived energy density. Rather food reinforcement is associated with actual energy density and therefore, on an implicit knowledge of caloric content. That implicit knowledge must have a neural signature and a mechanism by which the gut communicates nutritive value to the brain. There is evidence, at least for fat and carbohydrates, that these pathways are separable, but terminate in a common neural structure, the dorsal striatum or caudate. This could be one mechanism by which modern processed foods high in both fat and carbohydrate are so sought after and readily consumed, In fact, when experimentally tested, fat and carbohydrate combinations were more reinforcing calorie for calorie than fat or carbohydrates alone and the level of reinforcement correlated with activity in reward- related brain areas. Beyond simple reinforcing value, it is known from the literature on drugs of abuse that the faster a drug is arrives at the brain, the higher it's abuse potential, however, little is known about how the kinetics of nutrient excursion influence food preference, choice, and brain activity. This project aims to test this specifically for carbohydrate reward.


Eligibility Criteria:
Inclusion Criteria:

1. BMI between 18.5-30 kg/m2
2. Not pregnant or planning to become pregnant during study participation
3. Residing in the Roanoke area and/or willing/able to attend sessions at the Fralin Biomedical Research Institute
4. Able to speak and write in English

Exclusion Criteria:

1. Current inhaled nicotine use
2. History of alcohol dependence.
3. Current or past diagnosis of diabetes or thyroid problems.
4. Taking medications known to influence study measures (including antiglycemic agents, thyroid medications, sleep medications)
5. Active medical or neurologic disorder.
6. Current shift work (typical pattern of work/activity overnight)
7. Previous weight loss surgery
8. Adherence to a special diet within the past 3 months (e.g., low-carb or ketogenic diet, exclusion of food groups/specific macronutrients, intermittent fasting, etc.)
9. Allergy to any food or ingredient included in the study diets, meals, or beverages
10. Currently pregnant or planning to become pregnant during study participation
11. Claustrophobia
12. Contraindications for MRI, including pacemaker, aneurysm clips, neurostimulators, cochlear or other implants, metal in eyes, regular work with steel, etc.
Determination of Optimum Duration of Treatment With Bromfenac (Xibrom) Eyedrops Following Cataract Surgery

The objective of this study is to determine if an extension of bromfenac BID monotherapy is effective in the decreasing retinal thickening post cataract IOL placement surgery. No studies exist on how long to treat with an NSAID post cataract IOL placement surgery. Currently, NSAID therapy post IOL placement surgery is in conjunction with steroid treatment, lasting approximately 3 weeks. This study is designed to examine if there is benefit to extending NSAID monotherapy in regards to macular thickening and the incidence of CME.


Eligibility Criteria:
Inclusion Criteria:

* Male or female \>18 years of age scheduled to undergo bilateral cataract surgery
* Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (e.g. diabetics with normal retinal exams)
* Expected visual outcome of BCVA \> \[greater than or equal to\] 20/30 postoperatively
* Ability to provide informed consent, take study medications as directed, and likely to complete all study visits

Exclusion Criteria:

* Known contraindication to any study medication or any of their components
* Required use of ocular medications other than the study medications during the study
* Significant AMD, epi-retinal membrane, retinal vein occlusion, diabetic macular edema, or any macular disease predisposing them to cystoid macular edema.
* Posterior capsule rupture, Vitreous loss during surgery or any other complication that in the surgeon's opinion, could reduce potential for targeted visual outcome
* Anticipated need for mechanical iris dilating devices
A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs

This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>=18 years of age;
* moderate to severe rheumatoid arthritis;
* inadequate response to current non-biologic DMARDs

Exclusion Criteria:

* rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
* previous treatment with other biologics.
Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery

Use of neuromuscular blockade (NMB) may improve the surgical work space in patients scheduled for laparoscopic surgical cases (e.g. hysterectomy, ovarian cystectomy, myomectomy). Clinical studies investigating this question often use a numerical or verbal rating scale for subjective evaluation of the surgical workspace. However, no good subjective rating scale have been developed or validated. Neither have possible inter-individual differences in use of such subjective scales been described.

Purpose:

The aim of this study is to validate different subjective rating scales to determine which scale is most useful among surgeons.


Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 years old
* elective gynecologic laparoscopic operation
* can read and understand Danish
* informed consent

Exclusion Criteria:

* BMI \> 30 kg/cm2
* known allergy to medications that are included in the project
* severe renal disease, defined by S-creatinine\> 0,200 mmol/L, GFR \< 30ml/min or hemodialysis)
* neuromuscular disease that may interfere with neuromuscular data
* lactating or pregnant
* impaired liver function
* converting to laparotomy
* perioperative use of neuromuscular blocking agents before randomization
* pneumoperitoneum set to \>12 mmHg on the insufflator
An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's Lymphoma

This is a prospective, observational, longitudinal, multicenter study of patients with newly diagnosed follicular Non Hodgkin's Lymphoma (NHL) designed to delineate differences in clinical outcome by comparing the effectiveness and safety of common treatment regimens.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form (unless the Institutional Review Board \[IRB\] has granted a waiver of consent)
* Signed Authorization for the Use and Disclosure of Health Information document
* Age ≥18 years
* Histologic documentation of follicular NHL, according to Revised European-American Lymphoma (REAL) classification system, as assessed by the local pathologist and treating physician
* Initial diagnosis of follicular B-cell NHL within 6 months prior to enrollment
* Availability of cancer-specific historical data points in the patient's medical records

Exclusion Criteria:

* Other indolent or histologic NHL subtypes
* Diagnosis of lymphoma \> 6 months prior to enrollment
FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)

The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-38 years old;
* BMI: 18-28 kg/m2;
* Less than 3 previously completed IVF cycles;
* Basal FSH \<10 IU/L and E2 \<80 pg/ml;
* TSH \< 2.5 mIU/L
* \>10 and \<30 antral follicles 2-10 mm in size for both ovaries combined
* AMH: \>1 ng/ml (7.15 pmol/l) and \<5.6 ng/ml (40.0 pmol/l)
* Presence and adequate visualization of both ovaries;
* Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination;

Exclusion Criteria:

* Primary ovarian failure or women known as poor responders;
* PCO and PCOS;
* Severe OHSS in a previous COH cycle;
* Uterine malformation that may impair the possibility to get pregnant;
* Ovarian cysts \>10 mm;
* Hydrosalpinx that have not been surgically removed or ligated;
* Endometriosis stage 3 or 4;
* Oocyte donation;
* Severe male factor;
* Pathologies associated with any contraindication of being pregnant;
* History of recurrent miscarriage (more than 3 previous miscarriages);
* Hypersensitivity to the study medication;
* Abnormal bleeding of undetermined origin;
* Uncontrolled thyroid or adrenal dysfunction;
* Neoplasias;
* Severe impairment of renal and/or hepatic function.
Simultaneaous Detection of Quantitative Somatic Alterations Using the Qantitative Multiplex Pcr of Short Fluorescent Fragments Method (QMPSF) in Stage II-III Colon Cancer: a Prospective Study

Lymph node involvement remains the main criteria for postoperative chemotherapy in patients with colon cancer (CC) without distant metastasis. To date, the prognostic value of the somatic quantitative molecular alterations such as loss or gain of genomic region is not established in CC.

AIMS \& METHODS: Using the one-step screening method based on the Quantitative Multiplex PCR of Short fluorescent Fragments (QMPSF), we aimed to assess the prognostic role of the simultaneous detection of main quantitative somatic alterations in stage II-III CC.

Patients and Methods. We enrolled and collected all baseline characteristics of patients operated for a stage II-III CC with storage frozen tissues. The QMPSF was based on a simultaneous amplification of 9 selected target genomic sequences from literature: DCC (18q21); EGFR (7p12); P53 (17p13.1); BLK (8p23-p22); c-myc (8q24.12); APC (5q22.2); ERBB2 (17q12); STK6 (20q13.31); NR21 (14p11.1) and two control: DCOHM (5q31.1); HMBS (11q23.3). Comparison of each amplicon electropherograms obtained from tumour vs normal peritumoral tissue allowed us to identified gain or loss genomic region. The primary end-point was the local and/or distant recurrence and relation between clinical and single or combined molecular alterations and recurrence were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* age over 18
* localized colon cancer
* proven adenocarcinoma
* surgery R0
* no metastatic disease
* stage II or III
* WHO performance status 0, 1 or 2
* availaible frozen tissue
* written consent
* no major co-morbidities

Exclusion Criteria:

* metastatic disease
* hereditary colorectal cancer
* rectal cancer
The Early Integrated Intervention for Child Brain-developmental Disorders in China

This study is focused on developing the early integrated intervention for child brain-developmental disorders, including globe developmental delay (GDD), autism spectrum disorder (ASD), and attention deficit-hyperactivity disorder (ADHD), in China.

The early integrated intervention of GDD and ASD is developed by Children's Hospital of Fudan University.

The early integrated intervention of ADHD is developed by Nanjing Brain Hospital.

Eligibility Criteria:
Inclusion Criteria:

* GDD: IQ\<70, in more than 2 areas of development;
* ASD: Diagnose must meet the criteria of DSM-V;
* ADHD: Diagnose must meet the criteria of DSM-V, and IQ\>70 tested by Wechsler Intelligence Scale；
* At least one of the parents could take part in the whole courses, and do the training at home.

Exclusion Criteria:

* Physical disability, visual or hearing loss;
* Combined other sever chronic diseases: liver or kidney function failure, rheumatic diseases, or tumor, and so on;
Cognitive Function and Body Mass Index in Children and Adolescents

The child will complete computerized tasks and paper-pencil test, and will be presented with symbols, letters, or numbers on a computer screen and asked to respond by pressing a button on the computer. Before each task a researcher will explain the instructions of the task and assess if the child needs a break before completing the next task. While the child is completing computerized tasks, the parent/guardian will be asked to fill out paper-pencil questionnaires about the child and to sign a release of medical information form so that we can study how physical markers of health effect cognition.


Eligibility Criteria:
Inclusion Criteria:

* Local population (based on ethnicity)
* Healthy or overweight/obese

Exclusion Criteria:

* History of developmental delay or disorders
* History of any medical conditions ( that may impact the development)
Low Dose Euthyrox in Treatments of Paraquat Intoxication.

Paraquat is a common human toxicant and accounts for 20 deaths per million persons in the world. Paraquat usually cause multiple organ dysfunction syndrome, including liver, kidney, lung and heart dysfunction. Besides, pituitary insufficiency also occurs on those patients with paraquat poisoning, which leads to multiple endocrine gland dysfunction, involving adrenal gland, thyroid and sex gland.

As a result, the investigators decide to initiate the clinical trial to find whether thyroid replacement therapy can furtherly reduce the mortality, and improve patients long-term prognosis.

Paraquat is a common human toxicant and accounts for 20 deaths per million persons in the world. Its accidental or deliberate ingestion is associated with a high mortality rate ranging from 40% to 70%. Paraquat usually cause multiple organ dysfunction syndrome, including liver, kidney, lung and heart dysfunction. Besides, pituitary insufficiency also occurs on those patients with paraquat poisoning, which leads to multiple endocrine gland dysfunction, involving adrenal gland, thyroid and sex gland. Nowadays, steroids, as a hormone replacement therapy, is one of most important drugs for paraquat poisoning, and it has decreased patients' mortality greatly since using it. However, the clinicians have not paid enough attention to thyroid replacement therapy, as thyroid dysfunction is also the key pathophysiological course when paraquat poisoning occurs.

As a result, the investigators decide to initiate the clinical trial to find whether thyroid replacement therapy can furtherly reduce the mortality, and improve patients long-term prognosis.

Eligibility Criteria:
Inclusion Criteria:

* all the patients who are diagnosed by paraquat poisoning

Exclusion Criteria:

* patients who can not cooperate with the trial; patients who would not like to join in the trial.