cyrilzakka/clinical-trials huggingface dataset:
Smart Marker Annunciating Response to Rheumatologic Treatments SMART²T

European recommendations indicate to start a conventional synthetic disease modifying antirheumatic drug (csDMARD) as soon as possible to reach the remission in early RA or low disease activity in established RA. If the target is not achieved with the first csDMARD and in presence of poor prognostic, addition of a biologic (b)DMARD or a targeted synthetic (ts)DMARD should be considered . Nevertheless, as many as one-third of patients have persistent disease activity and insufficient (inadequate) response to a first b/tsDMARD according to international recommendations. This relatively long time (3 to 6 months) between treatment initiation and determination of individual clinical response represents:

* a risk for the patient who could be usually exposed to potential side effects,
* a loss of chance for the patient who will not receive an adequate treatment during the most favorable period and thus may develop irreversible lesions
* a cost for the healthcare system, especially in terms of expensive drug reimbursements, notwithstanding the increasing use of biosimilars.

Despite 20 years of research, no biomarker or no way are available in the daily practice to predict disease activity and the non-response to a b/tDMARD \[11\]. Thus exploration of a new approach is totally in purpose.

The aim of this project is to benefit from the declarative PRO (Patient Reported Outcomes), the physical activity and sleep quality to predict the individual clinical response to the b/tsDMARDs


Eligibility Criteria:
Inclusion Criteria:

* Social security affiliation
* Signed informed consent
* Adult patient (over 18 years old)
* RA according to ACR/EULAR 2010 criteria since less than 6 months
* DAS28 ≥ 3.2 despite methotrexate therapy and initiating for the first time a bDMARD or a tsDMARD
* Having an internet access at home and using an email address

Exclusion Criteria:

* Other arthritis than RA
* To participate to a blind-randomized study to assess RA treatment
* Pregnancy or breastfeeding
* Patient unable to understand the study, unable to give consent
* Patient deprived of liberty or patient under guardianship
* Patient refusing to participate in the study
* Patients having difficulty using connected objects
Comparison of rhBSSL With Placebo When Added to Infant Formula or Pasteurized Breast Milk During 4 Weeks of Treatment in Preterm Infants

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo.

The purpose of this study is to demonstrate that rhBSSL improves growth in preterm infants as compared with placebo. The infants should be born before week 32 of gestational age.

The study drug, rhBSSL or placebo, will be administered during a 4 week treatment period by adding it to either infant formula or pasteurized breast milk.

The study will also evaluate the safety and tolerability of rhBSSL.

Eligible patients will be randomized in a ratio of 1:1 (rhBSSL:placebo). The study consists of maximum 1 week screening period, a 4-week treatment period and a 2 year follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Preterm infants born before week 32 of gestation.
* Preterm infant who is less than 33 weeks postmenstrual age at the time of randomization.
* Preterm infant who is appropriate for gestational age (AGA) or small for gestational age (SGA) at birth.
* Preterm infant who is receiving food enterally (bottle or gavage tube) at a level of at least 100 ml/kg/day at randomization.
* Preterm infant whose enteral feeding consists of only infant formula or only pasteurized breast milk at the time of inclusion, and who are expected to remain on only infant formula for 4 weeks, or only pasteurized breast milk for at least 2 weeks following treatment initiation.
* Preterm infant who is expected not to receive any fresh breast milk for 4 weeks following treatment initiation.
* Informed consent is obtained.

Exclusion Criteria:

* Expected stay in the hospital is less than 4 weeks from the first dose of study drug.
* Criteria to ensure no disease or treatment affecting growth or development, e.g. brain disease, necrotizing enterocolitis.
* Enrolled in another concurrent clinical intervention study.
Effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas in Non-Specific Low Back Pain

This study is a randomized controlled trial and the purpose of this study is to determine the effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas combined with core stability exercises in Non-Specific Low Back Pain"

The purpose of this study is to determine the effects of Static Stretching Versus Post Facilitation Stretch of Iliopsoas on Pain, physical function, lumbar ROM and Hip ROM in patients Non-Specific Low Back Pain" adults (age : 30-50 years )

1. Numeric pain rating scale
2. Goniometer
3. Inclinometer
4. Oswestry Disability Questionairre Data will be collected before and after the intervention protocol for each participant.

Data collection procedure: Participants of interest would be approached and explained about the research. Informed written consent will be taken. Pre and post intervention scores will be recorded.

Eligibility Criteria:
Inclusion Criteria

* Gender: Both male and female
* Individuals aged 30-50 years
* Non-Specific low back pain for at least 3 months
* pain radiating no further than the buttock
* Pain range between 3-8 on NPRS
* Positive Thomas Test

Exclusion Criteria:

* Diagnosis of systemic metabolic and/or neurological disorder, neuromuscular disorders, pregnancy
* Patients who have been receiving any other physical therapy treatment for NSLBP in the same period of the interventions
* Patients having Low back pain with any specific cause
Silodosin in Retrograde Intrarenal Surgery

Selective alpha-blockers have been used for the treatment of ureteric stones as medical expulsive therapy (MET). Recently they have been successfully used in passive ureteric dilatation before semirigid ureteroscopy. This study enables us to know the role of silodosin in ureteric dilatation to facilitate ureteral access sheath placement in Retrograde Intrarenal Surgery with flexible ureteroscopy.

The ureteral access sheaths (UAS) used during Retrograde Intrarenal Surgery (RIRS) were produced for easy access to the upper urinary tract. The main advantages of UAS are providing repetitive access to the ureteral and collecting duct system, decreasing intrarenal pressure, preventing bleeding-related distortion of vision by the acceleration of liquid flow, and eventually contributing toward the protection of the flexible device.

Nevertheless, there might be certain challenges during UAS placement. There are also risks, such as ureteral injury and the occurrence of ureteral stricture in the long term. However, considering the benefit/risk balance, RIRS is routinely performed in many clinics because of the ease provided by UAS.

Some problems might occur during the placement of UAS whose diameters vary between 9.5 and 14 Fr. In cases where UAS cannot be placed, manipulations can be used, such as ureteral balloon dilatation, providing access through a rigid ureteroscope with a guide wire, or dilatation with the inner sheath of the UAS, which may vary depending on the amount of personal experience. Despite such manipulations, if UAS placement is still unsuccessful, it is always more logical to place a double-J stent, enables passive dilatation, and postpone RIRS until the second operation.

This study will examine whether intramural ureteral resistance can be reduced or not and whether UAS placement can be facilitated using silodosin or not.

Eligibility Criteria:
Inclusion Criteria:

* Both sex.
* Age \>18 yrs old.
* Upper ureteric stones or renal stones \< 2 cm.
* Patients with normal renal anatomy.
* No history of infectious or inflammatory renal condition.

Exclusion Criteria:

* • \< 18 years old.

  * Multiple or bilateral stones.
  * Pregnant women.
  * Ureteric strictures.
  * Urinary tract infection.
  * Coagulopathy and uncorrected bleeding disorders.
  * Refusal of the surgery and requiring stent.
LUNG FIBROTIC CHANGES ASSOCIATED WITH SARS-CoV-2 INFECTION

Prospective, observational, multicenter study that will evaluate the changes in lung function that patients admitted with SARS-CoV-2 pneumonia will present according to the level of severity at 4, 12, 26 and 52 weeks after hospital discharge.

The project consists of a prospective, observational, multicenter study that will evaluate changes in lung function (forced spirometry, measurement of static lung volumes using plethysmography and pulmonary carbon monoxide diffusion test) that patients admitted with pneumonia will present. caused by SARS-CoV-2 according to the level of severity at 4, 12, 26 and 52 weeks after discharge from hospital. Restrictive pulmonary abnormalities will be confirmed by imaging tests (high resolution chest CT).

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted for bilateral pneumonia caused by SARS-CoV-2 (confirmed by PCR).
* Age over 18 years.
* Acceptance of informed consent.
* Life expectancy over 1 year.

Exclusion Criteria:

* Patients with a previous diagnosis of interstitial lung disease.
* Inability to attend review visits.
Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)

This phase I research protocol is designed to assess immunogenicity and clinical endpoints in patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The protocol tests the use of artesunate in suppository formulation applied intravaginally in patients with cervical dysplasia (CIN2/3).

The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility of intravaginal administration of artesunate in health women with CIN2/3.

Phase I open-label dose escalation study of intravaginal artesunate, formulated in suppositories, in adult females with biopsy-confirmed CIN2/3. Thirty (30) subjects will undergo up to a total of three cycles of intravaginal artesunate. The first cycle will be initiated on Day 0, the second at Week 4, and the third and final cycle at week 8.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Capable of informed consent
* HPV-positive by DNA test
* Histologically confirmed CIN 2, CIN 3, or CIN 2/3
* Body weight ≥ 50 kg
* Immune competent

Exclusion Criteria:

* Pregnant and nursing women
* HIV seropositive
* Active autoimmune disease
* Taking immunosuppressive medication
* Evidence of concurrent adenocarcinoma in situ
* Concurrent malignancy except for nonmelanoma skin lesions
Safety and Efficacy of Convalescent Plasma Transfusion for Patients With COVID-19

This is a multicenter double blinded study to evaluate the efficacy and safety of convalescent plasma from COVID-19 recovered individuals to treat hospitalized patients with severe COVID-19 disease. The study will enroll 410 subjects who will be randomized 1:1 to receive convalescent plasma or normal saline solution in a blinded manner. The primary endpoint will be improvement on the 8 point WHO scale over 28 days. Mortality at day 28 will be a secondary endpoint. An interim analysis will be done when 224 patients have completed their follow up to assess safety and to indicate continuation or stopping of the study, based on safety and efficacy observed.

A total of 410 patients with COVID 19 who fulfill inclusion criteria will be invited to receive:

Human convalescent plasma from recovered patients in two infusions of 200 ml separated with 24 to 72 hours or Normal saline solution in a similar plasma bag. Both products will be covered in an identical material to avoid identification of the infused product.

Primary endpoint:

Improvement on the 8 point WHO scale over 28 days.

Secondary endpoints.

Mortality at day 28

* Presence of antibodies against SARS-CoV-2 in serum on days 0, 3, 7, 14, 21 y 28 after plasma administration, as long as the patient remains in the hospital.
* Disease progression to a worse stage compared to the baseline on admission to the study according to SOFA scale.
* Disease progression to a worse stage defined as worsening in at least two categories in the OMS disease scale on different timelines in comparison to baseline on admission to the study
* Number of hours on mechanical ventilation in those who enter the study on mechanical ventilation.
* Number of days with fever defined as temperature \>38°C on at least one occasion during the day

Inclusion criteria:

1. Adults older than 18 years.
2. Confirmed SARS-CoV2 infection
3. Patient hospitalized for COVID 19
4. Severe disease or risk for severe disease
5. Informed consent from patient or responsible person.

Exclusion criteria

1. History of allergic reactions to blood products
2. SOFA scale \>12 points
3. Absolute contraindication for administration of plasma
4. Participation in other blinded clinical trial
5. Projected life expectancy less than 3 months
6. Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.

Eligibility Criteria:
Inclusion Criteria:

1. Adults 18 years of age and older.
2. Confirmed SARS-CoV2 infection
3. Hospitalized for COVID 19
4. Severe disease or risk for severe disease
5. Informed consent from patient or responsible person.

Exclusion Criteria:

1. History of allergic reactions to blood products
2. SOFA scale \>12 points
3. Absolute contraindication for administration of plasma
4. Participation in other blinded clinical trial
5. Projected life expectancy less than 3 months
6. Any condition perceived by the investigator as not appropriate for participation of the patient in the trial.
A Study of MRG003 in Patients With Advanced Solid Tumors

The objective of this study is to assess the safety, efficacy, and pharmacokinetics of MRG003, as well as immunogenicity as defined by the incidence of anti-drug antibody (ADA) of MRG003 in patients with advanced solid tumors, including colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma.

This study consists of two parts: Phase Ia dose escalation and Phase Ib dose expansion. The objective of Phase Ia is to determine MTD or RP2D, and Phase Ib is conducted to evaluate efficacy of MRG003 in patients with advanced colorectal cancer, squamous cell carcinoma of head and neck (SCCHN), and nasopharyngeal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign the ICF and follow the requirements specified in the protocol.
* Age: ≥18 years and ≤75 years, both genders
* Expected survival time≥12 weeks
* Phase Ia: Patients with histologically and cytologically confirmed advanced or metastatic solid tumor
* Phase Ib: Patients with histologically and cytologically confirmed EGFR-positive advanced or metastatic colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma
* Subjects must have measurable lesions according to the response Evaluation Criteria In Solid Tumors（RECIST v1.1）
* ECOG performance score 0 or 1
* Acceptable liver, renal, and hematologic function
* Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment

Exclusion Criteria:

* History of hypersensitivity to any component of the investigational product
* Presence of central nervous system metastasis
* Prior history of other primary malignancies
* Known history of clinically significant hepatic diseases
* Evidence of active infection of human immunodeficiency virus (HIV)
* History of ophthalmic abnormalities
* Any severe or uncontrolled systemic disease judged by the investigator
* Patients with poorly controlled heart diseases
* Received radiotherapy, chemotherapy, biotherapy, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment
* Major surgery or surgical therapy for any cause within 4 weeks prior to the first dose of investigational drug
* Planned surgery or surgery is the best interest of patients as determined by investigator
* History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy
* Active concomitant diseases that might increase risks of toxicity
* Pregnancy, or breast feeding
Study of the Efficacy and Safety of Somatropin in Japanese Participants With PWS

This is a multicenter, open label, multi cohort study to evaluate the efficacy and safety of somatropin in a cohort of Japanese participants with PWS.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female participants with documentation of genetically confirmed diagnosis of PWS.
2. No plan to initiate a new treatment that may affect the body composition, such as gonadal hormone replacement therapy.
3. Currently on appropriate diet and exercise programs and willing to continue throughout the study period at the discretion of the investigator.
4. Participants, and if required by local/site regulations their parent(s)/legal guardian(s) must be willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
5. Evidence of a personally signed and dated ICD (and written assent where applicable based on age and country regulation) indicating that the participant or a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study. Refer to Appendix 1 for the detailed process of obtaining consent.

   For inclusion of GH naïve pediatric cohort, participants must meet criteria 6 to 8:
6. 18 years or younger.
7. Naïve to GH treatment.
8. Tanner stage 1 (for testes in males, for breasts in females).

   For inclusion of GH treated pediatric cohort, participants must meet criteria 9 and 10:
9. Continued GH treatment for at least 2 years with stable dose for the last 6 months and being on GH at time of inclusion. The recent dose should be higher than 0.084 mg/kg/week.
10. Participants who are about to complete GH treatment for his/her short stature (eg, due to meeting the treatment stopping criteria defined as a height SDS more than -2.5 for Japanese adult standards).

    For inclusion of adult cohort, participants must meet criteria 11 to 13:
11. 18 years of chronological age or older at Day 1 visit.
12. Off from GH treatment for at least 1 year.
13. Serum IGF-I level within +2 SDS, adjusted for age and sex.

Exclusion Criteria:

1. Participants with uncontrolled diabetes at the discretion of the investigator.
2. Participants with malignant tumors.
3. Participants with severe obesity or serious respiratory impairment.
4. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
5. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half- lives preceding the first dose of study intervention used in this study (whichever is longer).
6. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer

This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint. The study will evaluate the efficacy, safety and impact on quality of life of treatment with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu negative breast cancer will receive chemotherapy alone with oral Xeloda plus intravenous (iv) Taxotere (docetaxel). Patients with HER2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) Herceptin (trastuzumab). Patients will receive 3-weekly cycles of treatment with Xeloda (825mg/m2 oral administration \[po\] twice daily (bid) on days 1-14) + Taxotere (75mg/m2 iv on day 1). HER2-neu positive patients will also receive Herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* women \>=18 years of age;
* newly diagnosed;
* infiltrating (invasive) HER2-neu-negative or HER2-neu-positive breast cancer.

Exclusion Criteria:

* evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes;
* previous systemic or local primary treatment.
Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus

The aim of the study is to investigate the efficacy and safety of premixed insulin treatment in patients With type 2 diabetes mellitus using professional and personal Flash Glucose Mornitoring.

Professional and personal Flash Glucose Mornitoring will be used in patients with type 2 diabetes who are treated with premixed insulin. The frequency of hypogycemia and the blood glucose control will be analyzed by flash glucose mornitoring once a month for 3 months and doctors will adjust the hypoglycemia treatment according to the results every month. HbA1c, glycemic variation, beta-cell function and androgen levels will be measured.

Eligibility Criteria:
Inclusion Criteria:

1. participate voluntarily and sign the subject informed consent before the test.
2. for patients with type 2 diabetes who met WHO1999 diagnostic criteria, subcutaneous injection with premix insulin Bid/Tid, single drug and/or combination of oral hypoglycemic drugs, the treatment regimen was stable for more than 2 months.
3. no acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
4. subjects are able and willing to undergo FGM examination, diet and exercise regularly.

Exclusion Criteria:

1. patients treated with GLP-1 agonist in the last 3 months
2. patients who are allergic to insulin.
3. impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
4. a history of drug abuse and alcohol dependence within the past 5 years.
5. used systemic hormone therapy in recent 3 months.
6. patients with poor compliance and irregular diet and exercise.
7. patients with infection and stress within four weeks.
8. patients who cannot tolerate flash glucose mornitoring.
9. patients who are pregnant, nursing or or preparing to become pregnant.
10. any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.