cyrilzakka/clinical-trials huggingface dataset:
Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells

In this study we want to evaluate the clinical use of allogenic mesenchymal stem cells (MSC), obtained from bone marrow of healthy donors, for treatment of knee osteoarthritis. The trial is based in our own previous results with autologous MSC (ongoing NCT01183728 trial). We propose here a multicenter, phase I-II clinical trial, prospective, randomized, blinded, and controlled for the treatment of osteoarthritis (degrees II and III and IV). The assay consists of two arms with 15 patients each one. Patients in the experimental arm will be given an intra-articular transplantation of allogenic MSC, expanded "Ex Vivo" with our GMP-compliant procedure (MSV, PEI No. 10-134, authorized by the Competent Authority; same as in NCT01183728). In the control arm a standard treatment with intra-articular injection of hyaluronic acid shall be given. We shall follow the evolution of pain, disability, quality of life and quantitative changes in structure and composition of cartilage determined by T2-weighted MRI relaxation (Cartigram) for one year.


Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthritis grade II, III and IV of Kellgren and Lawrence assessed by two observers.
* Chronic knee pain with mechanical characteristics.
* No local or systemic septic process.
* Haematological and biochemical analysis without significant alterations that contraindicate treatment.
* Informed written consent of the patient.
* The patient is able to understand the nature of the study

Exclusion Criteria:

* Age over 75 or under 18 years or legally dependent
* Present Infection (to be included in the study no signs of infection must be evidenced)
* Congenital or acquired malformation resulting in significant deformity of the knee (varus\<10º; valgus\<20º) and leading to problems in application or evaluation of results.
* Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
* Women who are pregnant or intend to become pregnant or breast-feeding
* Neoplasia
* Immunosuppressive states
* Intra-articular infiltartion of any treatments in the last 3 months previous to study inclusion
* Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
* Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Pars Plana Vitrectomy Combined With Phacoemulsification Cataract Surgery in Phakic Diabetes Retinopathy Patients

Pars plana vitrectomy (PPV) is one of the most widely used surgical therapies to proliferative diabetic retinopathy in the world.

However, as a predictable consequence of PPV surgery, postoperative cataract is observed in 79%-95% of phakic diabetes retinopathy patients after PPV in 6-24 months and a subsequent cataract surgery is usually required. While, the subsequent cataract surgeries not only bring additional economy and workload burden, but also increase the surgical risks. Since the two-step surgical approach has its defects, the combination of PPV and phacoemulsification is an ideal surgical option.

This study is a multi-center prospective study, aimed to evaluate the effect of PPV combined with phacoemulsification cataract surgery in phakic diabetes retinopathy patients, and make a comparation between the combined surgery and the two-step surgery in patients without severe lens opacities.

The prevalence of diabetes retinopathy is increasing dramatically recent years. Pars plana vitrectomy (PPV) is one of the most widely used surgical therapies to proliferative diabetic retinopathy in the world.

However, as a predictable consequence of PPV surgery, postoperative cataract is observed in 79%-95% of phakic diabetes retinopathy patients after PPV in 6-24 months.Generally, subsequent cataract surgeries are required for the phakic patients within 6-16 months after the PPV surgery to improve visualization. While, the subsequent cataract surgeries not only bring additional economy and workload burden, but also increase the surgical risks because of the deep anterior chamber, zonular dehiscence, and inflammation. Since the two-step surgical approach has its defects, the combination of PPV and phacoemulsification is an ideal surgical option, which is only suggested in patients with severe lens opacities before the PPV surgery so far. For those with mild-moderate lens opacities, the benefits of combined surgery is unknown.

This study is a multi-center prospective study, aimed to evaluate the effect of PPV combined with phacoemulsification cataract surgery in phakic diabetes retinopathy patients, and make a comparation between the combined surgery and the two-step surgery in patients without severe lens opacities.

Eligibility Criteria:
Inclusion Criteria:

1. Proliferative diabetes retinopathy ;
2. Age over 45 years old;
3. mild-moderate lens opacities(LOCSⅢ : C3N3P3 or below);
4. recognition of at least one alphabet in ETDRS chart.

Exclusion Criteria:

1. Long-standing retinal detachment (more than three months), macular affected
2. Low Vision or blind on the other eye;
3. Macular degeneration, including age-related macular degeneration and Polypoidal choroidal vasculopathy;
4. Ocular trauma;
5. Glaucoma;
6. Hereditary retinopathy;
7. Severe lens opacities before the surgery (LOCSⅢ : C4N4P4 or above).
Interfant-21 Treatment Protocol for Infants Under 1 Year with KMT2A-rearranged ALL or Mixed Phenotype Acute Leukemia

This study is a treatment protocol with blinatumomab for infants under 1 year old who are diagnosed with acute lymphoblastic leukemia with a specific unfavorable genetic alteration. The purpose of the study is to improve the outcome of this disease in infants.

All infants that are eligible for this study and for whom the parents/legal representatives give informed consent will be enrolled in this study. All patients will receive one cycle of blinatumomab on top of the standard treatment backbone after induction therapy. Medium risk patients, that respond well to the 1st cycle will be treated with a 2nd cycle of blinatumomab replacing one chemo course after consolidation therapy. If they do not respond well enough they will be treated according to the current treatment standard. Minimal residual disease will be used to determine the response to blinatumomab. High risk patients will be eligible for allogeneic stem cell transplantation after the first blinatumomab cycle if they are Minimal Residual Disease (MRD) negative (defined as \< 0.01%). Also medium risk patients with insufficient MRD response after induction or after the 1st cycle of blinatumomab will be allocated to high risk treatment and will be eligible for allogeneic stem cell transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with newly diagnosed B- precursor acute lymphoblastic leukemia (ALL) or B- cell mixed phenotype acute leukemia (MPAL) according to the World Health Organization (WHO) classification of tumours of haematopoietic and lymphoid tissues (revised 4th edition 2017, with KMT2A-rearrangement.
2. ≤365 days of age at time of diagnosis of ALL
3. Written informed consent of the parents or other legally authorized guardian of the patient according to local law and regulations.

Exclusion Criteria:

1. KMT2A-germline patients
2. T-ALL
3. Age \> 365 days at the time of diagnosis
4. Relapsed ALL
5. Treatment with systemic corticosteroids (equivalent prednisone \>10 mg/m2/day) for more than one week and/or any chemotherapeutic agent in the 4-week interval prior to diagnosis. Patients who received corticosteroids by aerosol are eligible for the study.

Additional exclusion criteria for blinatumomab:

1. CD19 negative B-precursor ALL at diagnosis
2. CNS involvement (CNS2/CNS3 status) at the EOI. Patients with CNS disease at the time of diagnosis are eligible if CNS1 status is achieved prior to the start of the first blinatumomab cycle (lumbar puncture at \~day 33 of induction).
3. Proven hypersensitivity to the active substance or any of the excipients in blinatumomab.
4. Patients who have received a live vaccine 28 days prior to blinatumomab administration or plan to receive a live vaccine prior to B-cell recovery after the last dose of blinatumomab.

If exclusion criteria for blinatumomab are met, the patient should be treated according to the protocol but without blinatumomab.
The Role of Intestinal Microbiota Dysbiosis in the Development of Spondyloarthritis

The primary objective of this case-control study aims to explore the role of bacterium Ruminococcus gnavus (R. gnavus) with intestinal biopsy and faecal sampling in the initiation and the development of spondyloarthritis (SPA) in comparison with health control subjets (patients without chronic disease but have indication to digestive endoscopy).

As secondary objectives, the study aims:

* to research the abundance of bacterial strain of R. gnavus in mucosal sampling by biopsy;
* to study the interaction between R. gnavus bacterium and mucus from histological sampling;
* to correlate the expression of genes of intestinal mucus with the variations of identified microbiota of mucus biopsy;
* to study the interaction between bacteria and intestinal epithelial cells during culture;
* to demonstrate perturbations of the immune responses by dysbiosis.

Eligibility Criteria:
Inclusion Criteria:

Patients with SPA:

* Patients ⩾ 18 years;
* Diagnosed as spondyloarthritis (SpA) according ASAS classification;
* Affiliated to a social security scheme;
* Have signed the written informed consent form.

Control subjects:

* Subjects ⩾ 18 years;
* Subjects free of SPA and planned for a digestive endoscopy for another indication such as to explore the risk of colorectal cancer in family member;
* Affiliated to a social security scheme;
* Have signed the written informed consent form.

Exclusion Criteria:

* Subjects unable to understand the proposed study and/or sign a informed consent form;
* Pregnant women or breast feeding women;
* Subjects under guardianship or curatorship;
* Have taken antibiotic 1 month prior to inclusion;
* Presenting acute or chronic severe pathology may likely to interfere with the interpret of outcome;
* Refusal of subjects to participate to the study;
* Foreign patients under french AME scheme.
Piloting a Biomarker-augmented Alcohol Screening, Brief Intervention, and Referral to Treatment (SBIRT) Program Among HIV-affected Adolescents and Young Adults in Zambia

This will be a pilot study of an alcohol screening, brief intervention, and referral to treatment (SBIRT) program conducted within existing HIV prevention and treatment services for adolescents and young adults (AYA) in Lusaka, Zambia. The screening component of the program will feature both a self-report and a urine biomarker (ethyl glucuronide; EtG) to evaluate recent alcohol use. We will recruit 60 AYA to participate in the pilot. The specific aims of this pilot are to:

Specific aims:

1. Explore implementation factors of the SBIRT program within HIV prevention and treatment services through a process evaluation. We will quantitatively track the number of AYA in the SBIRT care cascade: 1) the number screened who have recent alcohol use; 2) the number of those with recent alcohol use who receive the brief intervention (BI); 3) the number of those who are referred for additional treatment; and 4) among those who are referred, the number who successfully link and complete treatment. We will collect time use data from clinic staff and counselors to estimate the time burden required for the SBIRT program. We will conduct 30 in-depth interviews with AYA three months after the screening. The sample will include adolescents who: (1) did not recently use alcohol; (2) received BI due to recent alcohol use that was low/moderate risk; and (3) were referred for treatment due to higher risk alcohol use. Interviews will focus on: (1) implementation factors (e.g., acceptability, feasibility) of the SBIRT program and (2) barriers and facilitators to the program's implementation. Focus group discussions and in-depth interviews will also be conducted with program staff (e.g., counselors, clinic staff) and other stakeholders (e.g., community leaders, policy-makers).
2. Evaluate the preliminary impact of the SBIRT program on AYA alcohol use. Among AYA who have recent alcohol use at screening, we will measure change in use at a three-month follow-up visit.


Eligibility Criteria:
Inclusion Criteria:

* 16-24 years of age
* Residing in Lusaka, Zambia
* Meets definition of HIV-affected as evidenced as being involved in HIV testing and treatment and Adolescent Friendly Spaces Programs at the three sites (we will not ask adolescents direct questions about HIV during screening; see Recruitment section).

Exclusion Criteria:

• Unable or unwilling to provide informed assent/consent
Safety and Pharmacokinetics of Subcutaneous Dose of IMG-007 in Healthy Participants

This is a double-blind, randomized, placebo-controlled study to assess the safety and PK profile of a single subcutaneous dose of IMG-007 in healthy participants. The study will comprise of a 5-week screening period, a 3-day In-patient Period in a clinical research unit (CRU) and an Out-patient Follow-up Period up to 127 days. The study will include 3 dose cohorts which will be enrolled sequentially. Participants will receive a single subcutaneous dose of IMG-007 or placebo at Baseline according to their assigned dose.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) greater than or equal to 18.0 kg/m2 and less than or equal to 32 kg/m2, and a minimum body weight of 50 kg for males and 45 kg for females
* Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent to participate in the study.
* Female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception.
* Male participants who agree to practice true abstinence or agree to use highly effective methods of contraception with female partners of childbearing potentials or are surgically sterilized.

Exclusion Criteria:

* Conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.
* Major surgery ≤ 4 weeks before the Baseline Visit or planned major surgical procedure during the study.
* Use of any prescription medication (except for hormonal contraceptives for female participants within the 14 days prior to the first dose.
* Drug or alcohol abuse.
* Use of more than 5 tobacco/nicotine-containing products per month within 3 months of the first dose.
* Hepatitis B, hepatitis C, or human immunodeficiency virus infection.
* Evidence of latent tuberculosis (TB) or a history of untreated or inadequately treated TB infection.
* Receipt of a live/live attenuated vaccine within 2 months prior to Baseline Visit.
* Hypersensitivity to study treatment or other biologics
* Participation in prior IMG-007 study or another research study involving an investigational product within 30 days (small molecule) or 3 months (biological product), or 5 half-lives (whichever is longer) prior to the Baseline (Day 1) Visit.
Examining the Efficacy of Kiko Exercises on the Prevention of Migraine Headaches

This pilot study hopes to show that after 3 months of Kiko training, Kiko naive patients with migraine will have a decrease in the frequency and severity of their migraines.

3.1 Study Design

Eligible subjects in this pilot study will be taught a series of Kiko exercises. Subjects who meet inclusion and exclusion criteria at the screening visit will be given a diary in which they will document their migraine frequency and severity for one month. Once subject diaries are complete, subjects will meet for a group lesson to learn the background of Kiko and study exercises. A DVD or videotape will be issued for subjects to use during practice at home. Subjects will maintain a diary of their migraine headaches, as well as a diary of their exercise routines. Subjects will meet weekly to reinforce training and encourage training continuation. Diaries will be collected at the end of the first, second, and third months.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, 18 to 70 years of age, with at least a 1-year history of migraine headaches
* With or without aura, (IHS criteria 1.1 and 1.2), who have experienced at least 4 migraines a month, or 2-3 migraines a month that last 2-3 days per attack in each of the 3 months prior to screening.
* The subjects must be naïve to Kiko and Qigong training.

Exclusion Criteria:

1. Subject has any cardiac condition, as determined by the investigator, that would preclude safe participation in a low level exercise program.
2. Uncontrolled hypertension at screening (sitting systolic pressure \>160 mmHg, diastolic pressure \>95 mmHg.)
3. Subject has had tension-type headaches, \>15 days/month in any of the 3 months prior to screening.
4. Subject has more than 8 migraines per month, or more than 16 days of migraine per month.
5. Subject is pregnant or expects to become pregnant during the course of the trial.
6. Subject has substance or alcohol abuse within the the last year which, in the investigator's judgement, will interfere with the study conduct, cooperation or evaluation and interpretation of the study results.
7. Subject has any concurrent medical or psychological condition that, in the investigator's opinion, may affect the interpretation of efficacy or safety data or which otherwise contraindicates participation in the trial.
8. Subject has participated in an investigational drug trial within the previous 4 weeks.
9. Subject uses pain medication in excess of 40 doses of over the counter medication and/or prescription pain medication per month to treat headaches of any type.
10. Subject is unable to differentiate between migraine and non-migraine headaches.
LODS Role in Predicting 30-day Mortality Outcome in ICU

LODS score for deceased ICU patients within 30 days is higher than survived ICU patients


Eligibility Criteria:
Inclusion Criteria:

* adult patient (age 18 years and above) admitted to ICU

Exclusion Criteria:

* patients admitted to ICU due to burn injury, coronary artery disease, post cardiac surgery
* patients with incomplete required information for LODS score
* patients deceased or discharged less than 24 hours of admission
Gastric CLEANsing by Intravenous AZithromycin in Urgent Endoscopy

This study will test the hypothesis that azythromycin is efficient and safe in cleansing the upper gastrointestinal tract for endoscopic examination in the case of acute bleeding.

In this study patients with upper GI bleeding will be randomzied to either i.v. azythromycin or placebo in order to evaluate the efficiency and safety of azythromycin for upper GI cleanliness during diagnostic endoscopy. A validated upper GI cleanliness score (Toronto score with values up to 10) and a visual analog scale will be used to evaluate cleanliness. Need for repeat endoscopy due to poor preparation, duration of hospitalization and requirement for blood transfusions during hospitalization will also be assessed. Adverse venets due to medication will also be recorded carefully.

Eligibility Criteria:
Inclusion Criteria:

* acute upper GI bleeding (\<12 hours)

Exclusion Criteria:

* prokinetics \<12 hours
* allergy to azithromycin
* use of contraindicated drugs (due to interactions)
* pregnancy
* physician option
A Study in Healthy Adults Investigating Eptinezumab Produced by 2 Different Manufacturing Cell Lines

Eptinezumab is a preventive treatment for migraine. The drug is made from a process that currently uses yeast cells for production of the drug. The trial researchers want to test whether using a new production cell line to make eptinezumab will affect the way the drug behaves in the body. To do this, the researchers will give a single dose of eptinezumab to healthy participants. Some of the participants will get eptinezumab that has been made from yeast cells. Others will get eptinezumab made with the new cell line.


Eligibility Criteria:
Key Inclusion Criteria:

* The participant has a body weight ≥50 and ≤100 kilograms (kg).
* The participant has a body mass index (BMI) ≥18.5 and ≤30 kg/meter (m\^2) at the screening visit and at the baseline visit.
* The participant has a resting supine pulse ≥45 and ≤100 beats per minute (bpm) at the screening visit and at the baseline visit.
* The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the screening visit and at the baseline visit.
* The participant is, in the opinion of the investigator, generally healthy based on medical history, a physical examination, vital signs, an electrocardiogram (ECG), and the results of the clinical chemistry, haematology, urinalysis, serology, and other laboratory tests.

Key Exclusion Criteria:

* The participant has taken disallowed medication \<1 week prior to the dose of investigational medicinal product (IMP) or \<5 half-lives prior to the screening visit for any medication taken.
* The participant has taken any IMP \<3 months or \<5 half-lives (whichever is longer) prior to the first dose of IMP.
* The participant has or has had any clinically significant immunological, cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, or psychiatric disease or other major disorder.
* The participant has been dosed with a monoclonal antibody (mAb) ≤6 months prior to the screening visit.
* The participant is a smoker or uses other nicotine-containing products (for example, snuff, nicotine patches, nicotine chewing gum, mock cigarettes, inhalers). Ex-smokers must have ceased smoking \>3 months prior to the screening visit.

Other inclusion and exclusion criteria may apply.
Vitamin D Treatment for Crohn´s Disease

The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.

Crohns Disease is an inflammatory disease of primarily the small intestine and colon.

In recent years scientists have hypothesized that low blood vitamin-D levels play a role in the development of autoimmune diseases, including Crohns disease. The purpose of this study is to examine whether vitamin-D is effective in keeping remission in inactive Crohns Disease (double blind placebo controlled trial). The patients who have active disease in the placebo group (reach primary endpoint), will in an open setting receive a higher single dose vitamin-D and the effect will be measured within 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Crohn's disease
* Inactive Crohn's disease for at least 4 weeks
* Crohn's Disease Activity Index (CDAI) \< 150
* C-reactive protein within normal range
* Serum albumin within normal range

Exclusion Criteria:

* Hypercalcemia
* Short bowel syndrome
* Pregnancy