cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate the Safety of ALLO-ASC-DFU in the Subjects With Dystrophic Epidermolysis Bullosa

This is a phase I/II open-label study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Dystrophic Epidermolysis Bullosa.

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a Dystrophic Epidermolysis Bullosa.

Eligibility Criteria:
Inclusion Criteria:

1. Age : 10\~60
2. Diagnosed with Dystrophic Epidermolysis Bullosa based on immunofluorescence test.
3. Bullous skin lesion sized over 10 cm\^2
4. Test negative for Serum β-HCG pregnancy test on screening, if the subject is fertile
5. A subject who is willing to follow the protocol and provide a informed consent on screening, given that the information with respect to the clinical trial is provided.

Exclusion Criteria:

1. A subject with history of epidermoid carcinoma within a year from screening.
2. A subject who requires antibiotics due to bacterial infection on skin.
3. A subject who was dosed with oral steroid, over 0.5mg/kg a day for subjects under 18, or over 20mg in 2 weeks for subjects over 18, within 30 days prior to screening.
4. A subject treated with radiotherapy or immunosuppressants, within 30 days prior to screening.
5. A subject treated with steroids locally, within 30 days prior to screening.
6. A subject with 2-times the maximum-standardized value of ALT, AST, ALP, bilirubin, total protein
7. A subject with 2-times the maximum-standardized value of BUN, Creatinine
8. A subject with Albumin below 2.0 g/dL.
9. A subject with Hemoglobin below 6 g/dL (anemic).
10. A subject with allergic response to bovine derived protein and fibrin glue.
11. A subject administered with biologic agents or cell therapy, within 30 days prior to screening.
12. A subject administered with stem cell treatment by IV or subcutaneously to the target wound, prior to the trial
13. A subject who enrolled into another clinical trial, within 30 days prior to screening
14. A subject with serious disease that can affect on clinical trial.
15. A pregnant or breast-feeding subject.
16. A subject with history of drug abuse within 1 year of clinical significance
17. A subject who cannot proceed according to the protocol.
Self-Acupressure on Pain, Fatigue and Sleep Quality in Systemic Lupus Erythematosus

The aim of this study is to examine the effect of Self-acupressure application on pain, fatigue and sleep quality in sle patients.

Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in our body in order to ensure the continuation and balance of the energy in our body.

Eligibility Criteria:
Inclusion Criteria:

* Being over the age of 18,
* Not using acupressure and similar integrative treatment methods,
* Not having a verbal communication disability (hearing and speaking),
* Not having a diagnosed psychiatric disorder,
* Not having a cognitive problem,
* Getting a score between 1-10 on the Piper Fatigue Scale,
* Getting a score between 1-10 on the VAS pain scale
* Agree to participate in the research.
* Not being in the active period of SLE (exacerbation in the last 3 months or not using steroids for 3 months)
* Not using other complementary and integrated health practices in the treatment process

Exclusion Criteria:

-
Qualitative & Quantitative Comparison of Hydrostatic vs Vacuum Casting Methods in Trans-Tibial Amputees

The purpose of this graduate research study is to compare hydrostatic and vacuum casting techniques using patient mobility indicators, volume displacement, comfort, and overall satisfaction outcomes in trans-tibial amputees.

Visit 1

* Informed Consent
* Subject will be casted using both the hydrostatic and vacuum system techniques

Visit 2 (7-10 days after Visit 1)

* One of two sockets will be randomly assigned and fitted/aligned by investigators
* Subject will be asked to perform a Timed Up and Go Test followed by a Six-Minute Walk Test
* Subject will fill out a comfort questionnaire for the prosthesis worn

Visit 3 (7 to 10 days after Visit 2)

• Subject will be asked to do the same testing as you performed in Visit 2

Eligibility Criteria:
Inclusion criteria :

* 18 years of age or older
* Trans-tibial amputation, unilateral
* Able to walk for a six-minute minimum w/o a break
* Amputation history of at least 6 months

Exclusion criteria:

* Syme amputation
* Physical disability or injury affecting a natural gait pattern
* Ulcers or blisters on the residual limb
A Study of Bevacizumab (Avastin) in Combination With Chemotherapy in Participants With Metastatic Cancer of the Colon or Rectum

This expanded access study will assess the efficacy and safety of intravenous (IV) bevacizumab in combination with chemotherapy regimens as first-line treatment of metastatic cancer of the colon or rectum. The anticipated median time on study treatment is approximately 10 months, and the target sample size is 40 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Previously untreated metastatic colon or rectal cancer
* Scheduled to begin IV 5-fluorouracil-based chemotherapy as a first-line treatment

Exclusion Criteria:

* Prior chemotherapy for metastatic colon or rectal cancer
* Planned radiotherapy for underlying disease
* Central nervous system metastases
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study start
* Treatment with any investigational drug, or participation in another investigational study, within 30 days prior to enrollment
Effect of CGM on Glucose Control in Non-insulin-treated Patients with Type 2 Diabetes Mellitus

The clinical value of CGM for diabetic patients undergoing insulin therapy has been widely recognized, but the evidence-based support for its use in non-insulin-treated type 2 diabetic patients remains insufficient. The primary objective of this study is to evaluate the effect of real-time continuous glucose monitoring (CGM) compared with self-monitoring of blood glucose on glycemic control in adults with non-insulin treated type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* (1)Subjects aged ≥18 years at screening (based on the day of signing the informed consent form) and of any gender
* (2)Patients diagnosed with type 2 diabetes
* (3)Prior to the screening, glycemic control was suboptimal with diet, exercise control, and oral medication or glucagon-like peptide-1RA (GLP-1RA) therapy maintained for more than 3 months, 7.5%≤HbA1c≤10%
* (4)Subjects voluntarily sign an informed consent form

Exclusion Criteria:

* (1)Patients treated with insulin within 3 months prior to screening
* (2)Currently or have used a CGM device within 3 months prior to enrollment
* (3)Serious skin disease at the sensor placement site, allergy to tape or adhesives
* (4)Pregnant females, those with a positive pregnancy test result at screening, or those who plan to become pregnant during the study
* (5)Those who are participating or will participate in other clinical trials
* (6)Those who, in the opinion of the investigator, should not participate in this clinical trial, such as: ①those who have a history of eye trauma or other diagnosed eye diseases resulting in visual impairment, etc.; ②those who are unwilling or unable to fully understand or cooperate due to speech disorders; ③those who suffer from mental disorders
Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis

In this first-in-human volunteer phase I clinical trial, a vaginal ring that slowly releases lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy volunteering women and left in place for 7 days. The primary objective of this phase I study is to assess the safety and the tolerability of this new intravaginal delivery system.

The eventual goal of this and related studies is to develop a vaginal ring that reduces recurrences in women suffering from bacterial vaginosis, which is the commonest form of vaginal infection.


Eligibility Criteria:
Inclusion Criteria:

* Good general physical and mental health
* Presence of normal (lactobacilli-dominated) vaginal microbiota
* Prepared to take oral contraception during the study

Exclusion Criteria:

* Pregnancy
* Lactation
* Systemic disease
* Menopause
* Recent use of antibiotics (\<1 week before entering the study)
* Recent use of intravaginal products or devices (\<1 week before enrolment)
* Presence of vaginal infection
Chemoradiotherapy With or Without Metformin in Locally Advanced Cervical Cancer

This is a prospective, single-center, phase II, randomized, window-of-opportunity trial initiated by researchers. The research hypothesis is that metformin can improve the level of hypoxia in locally advanced cervical cancer and further improve progression-free survival. The study aims to compare the improvement of tumor hypoxia with synchronous chemoradiotherapy with or without metformin, using CA-IX PET/CT and radiation positioning spectral CT to evaluate tumor hypoxia, screening hypoxic patients for inclusion in the study, and comparing the effects of synchronous chemoradiotherapy with or without metformin on the degree of hypoxia and progression-free survival in the two groups of patients.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18-70 years old
2. Pathologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
3. FIGO stage IB2-IVA
4. Baseline CT or MRI indicating tumor necrosis (clinical hypoxia)
5. Hemoglobin ≥90g/L (blood transfusions allowed); no prior chemotherapy
6. ECOG performance status 0-2
7. No severe hematopoietic dysfunction, and no significant cardiac, pulmonary, hepatic, renal dysfunction, or immune deficiency
8. Able to undergo PET/CT imaging
9. Feasible for gynecological examination and cervical biopsy
10. Not pregnant or breastfeeding

Exclusion Criteria:

1. Renal insufficiency with eGFR \<45 ml‧min-1‧1.73 m-2, and acute conditions that may lead to renal impairment such as dehydration, severe infectious diseases, shock, etc.
2. Diagnosed diabetes mellitus or current use of metformin or any other antidiabetic medication.
3. Concurrent diseases that may lead to tissue hypoxia (especially acute or exacerbated chronic conditions), such as acute heart failure, pulmonary fibrosis, respiratory failure, recent myocardial infarction, or blood pressure monitoring showing less than 90/60 mmHg, SpO2 \<90%.
4. Serum transaminases exceeding 3 times the upper limit of normal, liver failure, alcohol poisoning.
5. History of allergic reactions to compounds chemically or biologically similar to metformin.
6. Concurrent hypoglycemia, such as insulinoma, autoimmune hypoglycemia, or functional hypoglycemia, or fasting blood glucose persistently less than 2.8 mmol/L before enrollment.
7. Malnutrition, BMI \<18.5.
8. Concurrent unhealed gastric ulcer, duodenal ulcer, ulcerative colitis, Crohn's disease, or recent episodes of severe abdominal pain, diarrhea, vomiting, etc.
9. Concurrent rectovaginal fistula, vesicovaginal fistula, uncontrolled vaginal bleeding, or those at risk of fistula.
10. Inability to undergo intracavitary radiotherapy as assessed by the investigator.
11. Human immunodeficiency virus (HIV) infection.
12. Severe underlying diseases that are untreatable.
13. History of other malignant tumors (excluding cured basal cell carcinoma of the skin) or previous pelvic radiotherapy.
14. Currently participating in other clinical trials or stopped participating in clinical trials less than 4 weeks ago.
15. Neurological or psychiatric abnormalities affecting cognitive function.
A Longitudinal, Observational Biomarker Study in Participants With Primary Sjogren's Syndrome

The main objective of the study is to characterize the gene expression in immune and epithelial cells in salivary gland biopsy samples and blood of pSS (primary Sjögren's syndrome) and non-pSS participants including healthy volunteers.


Eligibility Criteria:
Key Inclusion Criteria:

For Healthy Volunteers:

* In good overall health as determined by the Investigator For Participants With Sicca
* Subjects should present with sicca (i.e., dry eyes and dry mouth) at Baseline
* Must be willing to undergo a minor salivary gland (labial) biopsy

Key Exclusion Criteria:

* A history of any clinically significant medical condition, as determined by the Investigator, that may impact study analyses
* A chronic or persistent infection human immunodeficiency virus (HIV), hepatitis B, hepatitis C, and/or tuberculosis
* Pre-existing connective tissue disease or autoimmune disease, such as systemic lupus erythematosus (SLE), rheumatoid arthritis, systemic sclerosis, or sarcoidosis
* Any known contraindications of sialoscintigraphy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Radiographic Assessment of Bone Dimension Around Immediate Implants With FDBA and I-PRF vs FDBA Alone

The present study is a human, prospective, parallel, randomised controlled clinical trial conducted for radiographic assessment of bone dimension around immediate implants with FDBA and I-PRF vs FDBA Alone The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.

Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients. All the patients were treated with immediate implants in endodontically and periodontically compromised sites. FDBA graft along with I-PRF is combined to form a sticky bone, this stable element is placed around the implants where bone is compromised.

The clinical and radiographic parameters were recorded at baseline, three months and six months postoperatively

Eligibility Criteria:
Inclusion Criteria:

1. Patients between 18-55 years of age.
2. Presence of non-restorable single rooted teeth (maxillary or mandibular) due to trauma, caries, root resorption, root fracture, endodontic or periodontal failure.
3. Grade I or Grade II extraction socket according to El Chaar et al 2016.
4. Good oral hygiene.
5. Good patient compliance.

Exclusion Criteria:

1. Systemic complications (uncontrolled diabetes and severe cardiovascular or infectious diseases).
2. Intravenous and oral bisphosphonate therapy.
3. Patients who are psychologically unable to participate.
4. Pregnant patients, patients with bone diseases and patients on chemotherapy or radiotherapy, alcohol or drug abuse.
5. Patients with hemorrhagic disorders.
Study Of Hernia Repair Utilizing The Bard Ventrio Hernia Patch

This study will collect data on patients undergoing hernia repair using the Bard Ventrio Hernia Patch. The study will evaluate hernia recurrence rates, operating time, quality of life and complications associated with the device and surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age ≥ 18
2. Be able to undergo study procedures
3. Have signed an Informed Consent form (ICF)
4. Be diagnosed with a ventral hernia requiring an open surgery for repair.

Exclusion Criteria:

1. Patient is participating in another device or drug study.
2. Patient exhibits clinical symptoms indicating infected hernia site.
3. Patient currently has a clean contaminated or contaminated site.
4. Patient has a life expectancy less than 2 years at the time of enrollment.
5. Anything in the opinion of the Investigator that would preclude the use of the Ventrio Hernia Patch, or preclude the subject from completing the follow-up requirements.
Multi-center Imaging Genetics Studies in China

To study the impact of genetic and environmental factors on high-level cognition associated neural circuits among healthy young Chinese Han subjects.

The investigators plan to collect behavioral assessment and environmental factors data,peripheral blood sample, MRI brain images in more than 10,000 healthy young Chinese Han individuals in order to build the pathway from gene to high-level cognitive phenotypes.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-30
* Chinese Han
* right-handed
* without history of neuropsychiatric disease
* no substance addiction
* smoking

Exclusion Criteria:

* younger or elder than 18-30 year-old
* other ethnics
* with history of neuropsychiatric disease
* with history of neuropsychiatric disease among first,second and third degree relatives
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis

The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.

This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:

   * Positive for anti-HCV antibody (Ab) or HCV RNA \> 1,000 IU/mL at least 6 months before Screening, and positive for HCV RNA and anti-HCV Ab at the time of Screening; or
   * HCV RNA \> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
2. Screening laboratory result indicating HCV genotype 1b-infection.
3. Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
3. Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
4. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)
5. Use of contraindicated medications within 2 weeks of dosing
6. Screening laboratory analyses showing any of the following abnormal laboratory results:

   * Calculated creatinine clearance (using Cockcroft-Gault method) \< 30 mL/min
   * Albumin \< 2.8 g/dL
   * International normalized ratio (INR) \> 1.8. Participants with a known inherited blood disorder and INR \> 1.8 may be enrolled with permission of the AbbVie Study Designated Physician.
   * Hemoglobin \< 10 g/dL
   * Platelets \< 25,000 cells per mm3
   * Total bilirubin \> 3.0 mg/dL
Immune Activation Markers in HIV-infected Patients Switching to Long Acting Dual Therapy

The purpose of the study is to measure the impact on immune activation and inflammatory markers of switching from a triple combination antiretroviral therapy (cART) to a long acting dual therapy in HIV-infected patients

Patients meeting the inclusion criteria will be offered to participate to the study.

In case of acceptance by given their writting consent, 6 ml of blood will be collected for measuring immune activation and inflammatory markers, during the blood test scheduled for the routine follow-up.

Six months after cART change, an equal volume of blood will be collected for measuring the same immune activation and inflammatory markers

Eligibility Criteria:
Inclusion Criteria:

* Patients agreeing to participate to the study and to collect their data
* HIV-1 infected subjects
* Patients switching from a stable (at least 6 months) and successful triple cART to a long acting dual cART
* Patients older than 18 yrs and regularly followed in Cannes and Nice hospitals
* Patients with a healthcare card

Exclusion Criteria:

* HIV-2 infected subjects
* Patients not being on successful and stable cART
* Patients having being treated during acute HIV-infection
* Patients modifying cART for virological failure
* Subjects modifying their treatment for another combination than from a triple cART to a dual cART
* Patients modifying cART during the 6 months of follow-up
* Patients refusing to participate to the study
* Patients included in an interventional study during the 6 months of follwo-up
* Patient under juridical procedure