cyrilzakka/clinical-trials huggingface dataset:
Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea

This study has been designed to investigate the comparative effects of sitagliptin vs. pioglitazone as add-on treatments in patients with type 2 diabetes who were uncontrolled on the full-dose of metformin and sulfonylurea


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes according to the American Diabetes Association
* Baseline level of 7% ≤ A1C \< 11% despite a minimum 6 months period of active treatment with metformin 2000 mg/day plus gliclazide 240 mg/day (uncontrolled type 2 diabetes)

Exclusion Criteria:

* Acute or chronic diseases of heart, lung, kidney,
* Active or past infectious conditions
* Malignancy
Project ACCEPT: Engaging Newly Diagnosed HIV+ Youth in Care

The proposed study is a two-group randomized repeated measures design that will examine the efficacy of Project ACCEPT (Adolescents Coping, Connecting, Empowering and Protecting Together) to improve engagement in care among youth newly diagnosed with HIV at five AMTU sites across the United States. Youth will be randomized into one of two study arms; Project ACCEPT, the intervention, or HEALTH, the health education attention-controlled comparison condition. Both arms consist of two individual sessions followed by six group sessions and a final individual session which is expected to take approximately nine weeks after which youth will have four follow-up visits at the following time points:

* post intervention (immediately after the last session);
* 3 months post the last session;
* 6 months post the last session; and
* 12 months post the last session. The trial will be repeated in up to three waves.


Eligibility Criteria:
Inclusion Criteria:

* HIV-infected and aware of his/her status as documented by medical record review or verbal verification by provider (i.e., medical or mental health care provider, case manager, social worker, etc.);
* Received HIV diagnosis within the past 12 months (+ 3 months) at the time of consent/assent as documented by medical record review or verbal verification with referring professional (i.e., medical or mental health care provider, case manager, social worker, etc.);
* Between the ages of 16-24 (inclusive) at the time of informed consent/assent;
* Receives services at one of the selected AMTUs or one of their community partners;
* Willing to participate in both the individual and group sessions;
* Ability to speak and understand spoken English;
* Able to understand and willing to provide signed informed consent/assent in English or Spanish; and
* Willingness to provide signed informed consent or assent with parental/legal guardian permission as applicable.

Exclusion Criteria:

* Participated in a previous wave, if enrolling into Wave 2 or 3;
* Intoxicated or under the influence of alcohol or other substances at the time of consent/assent;
* Visibly distraught and/or visibly emotionally unstable (i.e., exhibiting suicidal, homicidal, or violent behavior) in the opinion of the site personnel would interfere with the ability to give true informed consent; and
* Any concurrent participation in other behavioral studies. Permission from the protocol team may be provided for uncertain cases.
Evaluation of the COVID-19 Infection Response in Patients Admitted to the Emergency Department for Dyspnea

This research aims to improve our knowledge of the epidemiology of patients consulting in the COvid-19 Possible REspiratory Units (RECOP unit). Indeed, the epidemic linked to COVID-19 affects France and impacts its health system. The reception of all intermediate patients will be on the Emergency Structures (SU). Indeed, the French healthcare system centralizes unscheduled urgent care on the ER. The aspecific respiratory symptomatology in "intermediate" patients indicates them all the more at an admission to SU or the diagnostic approach to respiratory difficulty may be carried out.

A central issue of this diagnostic strategy will be to be rapid, since the diagnosis will have to be made in the context of significant flows, with a need to quickly refer patients to the most suitable downstream service, while limiting the risk contamination of caregivers and vulnerable patients if a COVID-19 + patient is admitted to an unsuitable service. However, virological tests do not currently allow rapid results for COVID-19.

Research project of investigatory aims to develop a predictive model of the risk of being COVID-19 positive for patients admitted to the emergency room for acute dyspnea.


Eligibility Criteria:
Inclusion Criteria:

* All patients over 15 years admitted to the RECOP unit for dyspnea

Exclusion Criteria:

* Patient admitted to shock for respiratory distress requiring immediate respiratory support.
* Patient under justice safeguard
A Pilot Study of Filtrum-STI in Children With Viral Gastroenteritis

This is a phase II double blind multicenter randomized placebo-controled clinical study aimed to find out whether treatment with Filtrum-STI (orally administered 0,4g tablets) is safe and effective in children with viral gastroenteritis. Filtrum-STI (lignin hydrolytic) is a drug with a high absorbing ability, that binds and eliminates toxins, pathogenic microorganisms and viruses. Filtrum-STI is inoffensive for mucous membranes, enhances colonic propulsion and improves its natural microflora. The drug is not toxic and well combines with other medication


Eligibility Criteria:
Inclusion Criteria:

* children aged 0-4 y.o. diagnosed with moderate viral gastroenteritis;
* 72 h or less from the onset of gastrointestinal symptoms.

Exclusion Criteria:

* severe diseases;
* individual intolerance of Filtrum-STI
* treatment with antiviral, immunomodulatory drugs during the study and 2 weeks before inclusion
* treatment with pre- pro- and antibiotics 2 weeks before inclusion
* participation in other clinical study 1 month before inclusion and during participation in the study.
Abnormal Regulation, Estimation and Cognitive Impacts of Physical Efforts as an Endophenotype of Anorexia Nervosa

The purpose of this study is to check if patients, but also relatives (as they share familial and genetic risk factors), are having more difficulties in regulating a spontaneous, pleasant physical effort (doing "too much") compared to healthy controls, and if physical efforts are participating to core symptoms of anorexia nervosa, such as more appetite (instead of less), less pain, more abnormal body image, and less cognitive flexibility.

Such a result could help to further understand the role of difficulties with physical exercise as part of the phenotype of anorexia nervosa.

This is a three steps protocol. First, patients (with anorexia nervosa), controls (with no eating disorder) and first degree relatives (with no eating disorder) will be tested for emotional accuracy (seing faces on a screen with different core emotions), pain threshold (how long they can support a cold probe), body size (how they see themselves), appetite and cognitive flexibility (a test where the capacity to change rules during a game is done easily or not).

Then all subjects will do a standardized physical exercise which represents an effort with the equivalent level of energy for each participants as being chosen according to each level of competency (assessed through the "maximal aerobic power").

The third step consists in the repetition of (nearly) initial tests.

Eligibility Criteria:
Inclusion Criteria:

Patients :

* Woman
* 18 - 50 years
* eating disorders (with or without bulimia) according to the EDI-2 (Eating Disorder Inventory) and the MINI (Mini International Neuropsychiatric Interview)
* BMI (Body Mass index) between 14 and 17,5
* first degree relative without ED (eating disorders)

First degree relatives :

* Woman
* 18 - 50 years
* Mother or sister of patient with eating disorders
* BMI (Body Mass index) upper to 17,5
* Healthy of all ED (eating disorders)

Controls :

* Woman
* 18 - 50 years
* BMI \> 17,5
* Without ED (eating disorders)

Exclusion Criteria:

All groups :

* Contraindication in the practice of an intensive sport
* Cardiovascular Family history with risk of cardiovascular unwanted events
* Cardiovascular, surgical personal Histories, ostéoarticulaires or musculo-tendinous against indicating to the practice of a sport
* Intercurrents psychiatric pathologies (humor or psychotics disorders, chronic or acute)

Related and controls :

Diagnosis of ED (eating disorders) in the EDI-2 and in the MINI
Using Botox to Treat Patients With Idiopathic Clubfoot

The purpose of this study is to determine the effectiveness of treatment of idiopathic clubfoot utilizing Botulinum Toxin Type A (Botox). This is not a hypothesis-generating study as we are reporting on outcomes of patients who have been treated by this method of clubfoot treatment.

Subjects with clubfoot will be assessed at the initial visit by Dr. Alvarez. During this visit, the first part of treatment, which is manipulation and casting of the clubfoot will be started. Following this visit, there will be weekly visits for continued manipulation and casting until no further correction of the clubfoot is seen. At this point, (usually after four weeks of casting or when the subject is 6-8 weeks of age), Botox® will be injected into the calf muscles of the affected foot or feet. Before the injection, the patch of skin overlying the intended site(s) of injection will be covered with a local anaesthetic cream (EMLA). This will be applied 30 minutes prior to the injection. This helps numb the skin where the injection will take place. A dose of 10 IU/kg Botox® will be used.

Following the Botox injection another cast will be applied. This will be followed by at least 3 more weekly cast changes to maintain the correction. After the casting and once the child's foot (feet) are big enough and have achieved a minimum of 15 degrees of ankle dorsiflexion with the knee in flexion, the bracing period will begin. This involves use of boots and bars which are worn fulltime until the child begins to weight-bear (usually occurs between 4 to 6 months of age). Until the child reaches skeletal maturity, there will always be a tendency for the foot to return to its clubbed position. Therefore, continued vigilance is part of the care for clubfoot. The following is the appointment schedule, assuming that there are no recurrences:

* Weekly appointments for 3 - 5 weeks for initial manipulation and casting
* Botox® injection
* Weekly appointments for 3 - 4 weeks for casting post Botox® injection or until the foot is big enough to fit in the brace
* Weekly appointments for 10 weeks (brace wear at this point)
* Monthly appointments for 9 months (brace wear at this point)
* Appointments every 6 months until your child reaches 8 years of age
* Yearly appointments thereafter until your child reaches 14 years or skeletal maturity

If there is a recurrence of clubfoot malposition, manipulation and casting will be reinstated and a possible repeat of injection of Botox® will be administered.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic clubfoot or clubfoot that is not associated with any other neuromuscular disorders or syndromes
3rd-year Post-surgical Evaluation of Adjacent Segment Disc Degeneration Onset in Lumbar Spine (Spinal Fusion vs. Lumbar Arthroplasty With Disc Replacement)

The main objective of the study is to compare the onset of adjacent segment disk degeneration in two groups of patients (one "spinal fusion group" and one "lumbar arthroplasty with disc replacement" group) with each patient acting as their own control for either group under study and more than three years of follow-up.

This is a non-randomized prospective monocentric open cohort study. Patients whose surgical intervention goes back to more than 3 years will be preselected from the KEOPS database and contacted by phone. Information on the study and its restrictions is delivered to the patient. The investigator organizes the inclusion visit. The patient is seen for consultation by the orthopedic surgeon (inclusion visit /end of research) ; the information notice is given to the patient who is free to ask questions about the study. The patient's consent is collected. The investigator proceeds with a clinical examination (the Lasègue manoeuver), evaluates pain (EVN, DN4) and administers four different questionnaires .

The patient is then oriented towards the imaging department where he/she will have the benefit of and Magnetic Resonance Imaging and also a spinal X-ray(front and profile ; Roussouly classification).

The patient's participation in the study ends once the examination is over. The consultation in the orthopedic department and the imaging session will be planned in such a way that they can be performed all on the same day.

The study program provides for 12 months of inclusion and 4 months of data management, statistical analysis and writing up the report on the study.

Eligibility Criteria:
Inclusion Criteria:

* All patients who have given written, informed consent.
* All patients covered by a health insurance scheme.
* All patients aged over 18.
* All patients operated with a lumbar spine disk prosthesis or vertebral arthrodesis with an anterior approach at the Orthopedic, Traumatology and Spine Surgery Department of Nimes University Hospital, France, at least 3 years previously.
* All patients who have undergone initial MRI before surgery.

Exclusion Criteria:

* Any patient taking part in a category 1 interventional study and in an exclusion period determined by a previous study.
* Any patient under legal protection, guardianship or tutorship.
* Any patient who refuses to sign the consent form.
* Any patient for whom it is impossible to give clear information.
* Any patient with contra-indications for Magnetic Resonance Imaging such as an incompatible pacemaker, claustrophobia, metal apparatus or prosthetic hip.
* Any patient with a septic complication.
* Any patient with instrumentation or posterior arthrodesis.
First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors

A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BBP-398, a SHP2 inhibitor, in patients with advanced solid tumors.

The first-in-human (FIH) study of BBP-398 will be an open-label, sequential-cohort, non-randomized, Phase 1/1B study utilizing BOIN dose escalation followed by an expansion phase in patients with MAPK pathway- or RTK-driven advanced solid tumors. The primary objective is to determine safety and tolerability of BBP-398, the MTD and RP2D. The secondary objectives are to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile, preliminary anti-tumor activity, objective response rate (ORR, complete response + partial response rate) and the duration of response (DoR) of BBP-398. The exploratory objective is to assess predictive biomarkers of response.

Eligibility Criteria:
Key Inclusion Criteria

* Male and non-pregnant females \>18 years old.
* Patients must have a diagnosis of advanced (primary or recurrent) or metastatic solid tumor with MAPK-pathway alterations as assessed by clinically validated and/or FDA-approved molecular diagnostic and no available standard of care or curative therapies (MAPK-pathway alterations include, for example KRASG12C mutant, EGFR-mutant).
* Dose expansion only: Patients with specific genomically defined tumor types will be recruited.
* Patients must have measurable disease by RECIST v1.1.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
* Patients must have adequate organ function.
* Patients must have the ability to understand and the willingness to sign a written informed consent document prior to the initiation of the study and any study procedures.
* Patients must be willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures.

Key Exclusion Criteria

* Patients with known active Hepatitis B, Hepatitis C infection, or HIV infection.
* Patients with a history of CVA, myocardial infarction or unstable angina within the previous 6 months before starting therapy.
* Patients with clinically significant cardiac disease.
* Patients with tumors harboring known activating mutations.
* Patients with a known additional malignancy that is progressing or requires active treatment.
* Patients with known central nervous system (CNS) tumors.
* Patients with known active CNS metastases and/or carcinomatous meningitis.
* Patients who have previously received a SHP2 inhibitor.
* Patients with inability to swallow oral medications or with gastrointestinal illness that would preclude the absorption of an oral agent.
* Patients on dialysis.
* Patients with a life expectancy of ≤12 weeks after the start of IP according to the investigator's judgement.
* Patients with known intolerance/hypersensitivity to BBP-398 or its excipients.
The Effect of Intrauterine Lidocaine Infusion and Oral Tramadol on Pain During Diagnostic Office Hysteroscopy

The purpose of this study is to compare the effectiveness of Tramadol and intrauterine lidocaine infusion in reducing pain during outpatient diagnostic hysteroscopy in postmenopausal women.

The purpose of this study is to compare the effectiveness of Tramadol and intrauterine lidocaine infusion in reducing pain during outpatient diagnostic hysteroscopy in postmenopausal women. Postmenopausal Women undergoing outpatient hysteroscopy in Cairo university will be divided into three groups, the first group will receive Tramadol 5mg 1 hour before the procedure, the second group will receive 20 ml lidocaine in 1000 ml normal saline infusion during the procedure, and the third will receive a placebo. A visual analog scale will assess pain.

Eligibility Criteria:
Inclusion Criteria:

* Menopausal patients with an indication for office hysteroscopy (postmenopausal bleeding or abnormal ultrasound findings)
* Consent to the procedure

Exclusion Criteria:

* Positive Chlamydia culture.
* patients who have an Allergy to local anesthesia or tramadol.
* A previous adverse reaction to any of the drugs used in the study.
* Patients were receiving any form of analgesia or current use of monoamine oxidase inhibitors.
* Nulliparous patients and patients with cervical pathology, retroverted uterus (detected by transvaginal ultrasound), and previous cervical surgery.
* Patients who have severe vaginal bleeding.
A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer

This study will evaluate the efficacy, safety and tolerability of HS-20093 compared with active surveillance as consolidation therapy after chemoradiotherapy in participants with limited-stage small cell lung cancer.

This is a randomized, controlled, open-label, multi-center, phase III clinical study to evaluate the efficacy and safety of HS-20093 versus active surveillance as consolidation therapy in participants with limited-stage small cell lung cancer (LS-SCLC) who have not progressed after receiving chemoradiotherapy (CRT).

This study consists of an experimental arm and a control arm. The experimental arm will be administered HS-20093, and the control arm will only receive active surveillance. Efficacy and safety were assessed in both arms by follow-up analyses.

Eligibility Criteria:
Inclusion Criteria:

1. Have signed Informed Consent Form.
2. Males or females ≥18 years old.
3. Patients with limited-stage SCLC who are deemed unsuitable for surgery or decline surgery.
4. ECOG performance status of 0-1.
5. Patients who have received CRT and have not progressed.
6. Minimum life expectancy \> 12 weeks.
7. Males or Females should be using adequate contraceptive measures throughout the study.
8. Females must not be pregnant at screening or have evidence of non-childbearing potential.

Exclusion Criteria:

1. Patients with mixed SCLC or NSCLC or sarcoma-like carcinoma, or large cell neuroendocrine carcinoma.
2. Patients with extensive-stage SCLC.
3. Disease progression during CRT or before randomization.
4. Received or are receiving the following treatments:

   1. For LS-SCLC, prior treatment with or current use of other chemotherapy regimens other than platinum plus etoposide
   2. Received any other anti-cancer treatment.
   3. Previous or current treatment with B7-H3 target therapy.
   4. Traditional Chinese medicine indicated for tumors within 2 weeks prior to the first dose of study drug.
   5. Major surgery within 4 weeks prior to the first dose of study drug.
5. Interstitial lung disease (ILD)/non-infectious pneumonitis.
6. History of other primary malignancies.
7. Inadequate bone marrow reserve or organ functions.
8. Severe, uncontrolled or active cardiovascular disorders.
9. Severe or uncontrolled diabetes.
10. Serious or poorly controlled hypertension.
11. Severe bleeding symptoms or bleeding tendencies within 1 month prior to randomization.
12. Severe arteriovenous thrombosis occurred within 3 months prior to randomization.
13. Serious infection within 4 weeks prior to randomization.
14. Presence of Grade ≥ 2 toxicities due to prior anti-tumor therapy.
15. Having serious neurological or mental disorders.
16. History of hypersensitivity to any component of HS-200093 or its similar drugs.
17. Participants with any condition that compromises the safety of the participant or interferes with the assessment of the study, as judged by the investigator.
Trial to Compare the Efficacy of Systane Ultra and Refresh Drop in the Treatment of Dry Eye in Asian Eyes

Systane Ultra is at least as efficacious and safe as Refresh Tears in Asian people with Dry Eyes

Comparison of efficacy of Systane Ultra and Refresh Tears

Eligibility Criteria:
Inclusion Criteria:

1. Subject age is between 40 and 65 years old.
2. Corneal fluorescein staining present in at least one/five sectors of at least one cornea
3. At least one question out of 6 questions on dry eye symptom present often or all the time.

   based on the Salisbury Eye study by Oliver Schein et al. (Does your eye feel dry, gritty, red, watery, crusted, stuck in the morning?) Please see appendix 1.
4. At least one of the following: TBUT \<= 5 s or Schirmer I less than 8 mm in at least one eye
5. Yamaguchi score 2 in at least one sector of one of 4 lids (slight advancement of Marx's line in line with Meibomian orifice)
6. Not using non-lubricant ophthalmic drops within the last 30 days and able to abstain from non-trial topical eye medications for 6 weeks.
7. Use of lubricants during the week before recruitment (ranging from 3 times in the week to less than 6 times a day every day).
8. Able to use saline eyedrops during the 7 day 'washout' evaluative phase, between 3 times over week to less than 6 times a day in all days.

Exclusion Criteria:

1. Known history of thyroid disorders (diagnosed by physician).
2. Known history of Sjogren syndrome or rheumatoid arthritis (diagnosed by physician).
3. No ocular surgery within 6 months and LASIK within 1 year.
4. Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
5. Ocular surface diseases such as pterygium, or obvious lid/orbital disease with lagophthalmos.
6. Anticipated necessity to wear contact lens in the duration of the study.
7. Not living in the same household as another participant of the study.
8. Any other specified reason as determined by clinical investigator.