cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of Venetoclax Combined With CACAG Regimen in the Treatment of Relapsed/Refractory Acute Myeloid Leukemia

The purpose of this study is to compare the efficacy and safety of venetoclax combined with CACAG regimen with BAT regimen in the treatment of relapsed/refractory acute myeloid leukemia.

Despite advances in therapies for acute myeloid leukemia (AML) in the past decades, some patients still suffer from relapsed/refractory (R/R) disease, resulting in poor outcomes. With a median overall survival (OS) of 4-7 months under classic chemotherapy approaches, it is imperative to explore new treatment options.Accumulating research has demonstrated the importance of epigenetic modification in the pathogenesis of chemoresistance. Recent studies have shown that combining venetoclax with hypomethylating agents (HMAs) such as azacitidine, or low-dose cytarabine (LDAC) improves the response and survival rates in R/R AML patients. To enhance the response rate, we designed a regimen that combines chidamide, azacitidine, cytarabine, aclarubicin, and G-CSF with venetoclax (CACAG+VEN regimen) for the treatment of patients with R/R AML. In this study, we intend to compare the efficacy and safety of venetoclax combined with the CACAG regimen with Best-Available Therapy(BAT) regimen in the treatment of relapsed/refractory acute myeloid leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are able to understand and willing to sign the informed consent form (ICF).
* All patients should aged 14 to 75 years,no gender limitation.
* Patients with R/R AML, diagnosed in accordance with the 2021 edition of the CMA criteria
* Liver function: ALT and AST≤2.5 times the upper limit of normal ,bilirubin≤2 times the upper limit of normal;
* Renal function: creatinine ≤the upper limit of normal;
* Patients without any uncontrolled infections , without organ dysfunction or without severe mental illness;
* The score of Eastern Cooperative Oncology Group (ECOG) is 0-3,and the predicted survival ≥ 4 months.
* Patients without severe allergic constitution.

Exclusion Criteria:

* Patients with allergy or contraindication to the study drug;
* Female patients who are pregnant or breast-feeding.
* Patients with a known history of alcohol or drug addiction on the basis that there could be a higher risk of non-compliance to study treatment;
* Patients with mental illness or other states unable to comply with the protocol;
* Less than 6 weeks after surgical operation of important organs.
* Liver function: ALT and AST\>2.5 times the upper limit of normal ,bilirubin\>2 times the upper limit of normal;Renal function: creatinine \>the upper limit of normal;
* The patient is not suitable for this clinical trial (poor compliance, substance abuse, etc.)
Maxillary and Mandibular Nerve Block

Mandibular fractures are among the most common (60-70%) maxillofacial fractures observed in emergency rooms. In the closed reduction (non-surgical), the bone fragments are realigned manually or by using traction devices. The open reduction surgery of mandibular fractures should first ensure the restoration of the occlusion of the mandible to prevent postoperative malocclusion, followed by stabilization by means of rigid fixations such as plates, screws, and rigid intermaxillary blocks in order to minimise any nonunion, malunion, or delayed union of the fracture segments. These surgical procedures are associated with moderate postoperative pain, being the first 24 hours the most intense pain period. Maxillary and mandibular nerve blocks are performed in patients with refractory trigeminal neuralgia. However, there have been few studies evaluating the analgesic effects of these blocks for maxillofacial surgeries.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) I/II patients,
* within the age group of 21-60 years
* both sex
* scheduled for elective faciomaxillary surgery

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patients with polytrauma
* Patients necessitating postoperative ventilation
* Oral or facial infection
* Coagulopathy
* Drug intake for chronic pain
* Known allergy to the study drugs
* Psychiatric disorder
Ancillary Effects of Oral Naloxegol (Movantik)

The purpose of this study is to find out whether oral Naloxegol can reduce the side effects of opioid painkillers following surgery. This study aims to explore whether Naloxegol can similarly reduce opioid-induced side effects in post-surgical patients. About 130 surgery patients will participate in this study which is being conducted at Cleveland Clinic Main Campus.

Opioids are the gold standard for postoperative pain management, but they have been shown to produce uncomfortable side effects such as urinary retention (an inability to completely empty the bladder), constipation and nausea/vomiting. Clinical evidence demonstrates that Naloxegol can safely and effectively block these undesirable side effects while maintaining the painkilling effects of opioids in outpatients suffering from opioid-induced constipation.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female or male aged at least 18 years
3. American Society of Anesthesiologists physical status 1-4;
4. Scheduled for elective primary hip or knee surgery under spinal anesthesia;
5. Expected to receive intravenous patient-controlled analgesia (IV PCA)
6. Expected to have significant postoperative pain
7. Negative pregnancy test

Exclusion Criteria:

1. Severe hepatic impairment, with/or twice the upper normal levels of liver enzymes
2. Severe renal impairment, or creatinine level \> 2.0
3. History of bladder cancer
4. Patients receiving perioperative regional anesthesia blocks
5. Presence of a sacral nerve stimulator
6. Medications (anticholinergic agents such as antihistamines, phenothiazines, antidepressants, antipsychotics), conditions or comorbidity causing urinary retention
7. Patient with requirement of urinary catheter insertion before or immediately post-surgery due to immobility
8. Urinary Tract Infections and other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which can cause urinary retention
9. Severe peptic ulcer disease, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases
10. Patients with known or suspected disruption of blood brain barrier, which may include but not limited to: Alzheimer's disease, stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, and Parkinson's disease
11. Gastrointestinal obstruction/Gastrointestinal perforation
12. Strong CYP3A4 inhibitors (some antibiotics, antifungals, protease inhibitors, and antidepressants), Strong CYP3A4 inducers, Other opioid antagonists
13. Hypersensitivity to MOVANTIK (naloxegol) or any of its excipients
Ischemic Stroke Nutrition Intervention Study

The primary goal of this clinical trial is to assess whether vitamin K2 or zinc supplementation can effectively improve skeletal muscle and neurological function in patients with ischemic stroke. The main questions it aims to answer are: 1. Does supplementation with vitamin K2 or zinc improve the subjects' muscle strength and muscle mass? 2. Can supplementation with vitamin K2 or zinc improve the subjects' neurological function after a stroke? Researchers will compare vitamin K2 or zinc supplements with a placebo to observe whether vitamin K2 or zinc supplementation can improve skeletal muscle and neurological function in patients with ischemic stroke. Participants will: 1. Take vitamin K2 (MK-7), zinc supplements, or a placebo daily for 2 years. 2. Attend face-to-face visits and provide biological samples and relevant data at 0, 3, 6, 9, 12, and 24 months (intervention phase). After the intervention, follow-up will continue for 1 year to observe the long-term effects.


Eligibility Criteria:
Inclusion Criteria：

Participants who meet all the following conditions will be included in the trial:

1. Men or women aged ≥ 18 years.
2. Patients with recent ischemic stroke（first or recurrent stroke no more than 7 days before admission）without significant residual limb paralysis, NIHSS score between 2-15, and muscle strength graded 2-4.
3. The patient and their legal guardian (or legally acceptable representative) voluntarily sign the informed consent form.

Exclusion Criteria：

Participants who meet any of the following conditions will be excluded from the trial:

1. Presence of consciousness disorders, aphasia, or swallowing disorders.
2. The diagnosis or suspicion of cerebral hemorrhage, atrial fibrillation, or other factors leading to cardiogenic cerebral infarction.
3. Coagulation dysfunction or use of vitamin K antagonists.
4. Suffering from chronic gastrointestinal malabsorption (such as celiac disease, short bowel syndrome), severe congestive heart failure, malignant hypertension, severe liver and kidney dysfunction, persistent malignant tumors (continuous treatment, or diagnosis of malignant tumors\<5 years), or other related diseases considered by researchers that seriously affect the patient's survival.
5. Having musculoskeletal diseases or cognitive impairment before the stroke.
6. Currently using or planning to use non research approved dietary supplements during the study period.
7. Currently using or planning to use drugs that affect cognitive or neurological function during the research period.
8. Restricted normal eating or currently receiving enteral or parenteral nutrition support.
9. Contraindications for MRI and other examinations.
10. Currently pregnant or planning pregnancy, currently breastfeeding.
11. Participated in a clinical trial using experimental drugs or devices within the past 3 months.
Adolescent Smoking Cessation in Pediatric Primary Care

This is a study of the effectiveness of adolescent smoking cessation interventions in pediatric primary care settings. Our specific aims are to:

1. Demonstrate providers' fidelity to guidelines for tobacco counseling and delivery of cessation interventions using practice system changes over time, (including systematic screening using charting tools and linkages to adjunct materials, including self-help handouts and Internet resources); and
2. Assess the impact of primary care provider counseling interventions on adolescent smoking cessation.

We hypothesize that adolescents who receive guidelines-based clinician-delivered smoking cessation counseling at primary care visits will be more likely to make quit attempts and more likely to remain abstinent (with better long term cessation rates) at 6 and 12 months after intervention, compared to those who do not receive interventions. In addition, we hypothesize that successful referral to stage-based self-help adjuncts, and more adjunct use will be associated with more quit attempts and better long-term cessation rates.

We will evaluate provider interventions in up to 120 pediatric practices, recruited from the American Academy of Pediatric's Pediatric Research in Office Settings (PROS) practice-based research network. Adolescents presenting for care will complete a short baseline survey prior to their doctor-visit, and a percentage of participants will be surveyed by phone 4-6 weeks after their visits to assess quit attempts and short-term cessation, and again at 6 and 12 months to evaluate long-term cessation outcomes. We will describe the patterns of smoking among youth, and explore how much receiving interventions affects motivation, quitting, abstinence/relapse attitudes, attitudes and use of adjunct strategies, and other smoking behaviors for adolescent smokers.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents presenting for regular well or sick visits at their pediatrician's office.
* Must live in a home or apartment with access to a telephone and mailing address.
* Must be able to speak English.
* Must be able and willing to give informed consent (if 18 years of age or older) or assent (if 14-17 years of age).
* In addition: parents/legal guardians of minors must be able and willing to give informed consent either in person or by phone in cases where the teen presents for care without a parent/legal guardian.

Exclusion Criteria:

* Adolescents who fall outside of the age range specified above.
* Unable to speak English.
* Do not have access to a telephone and/or mailing address.
Lifestyle Modification for Obesity-Related Type 2 Diabetes

Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary evidence suggests that low carbohydrate diets improve glycemic control when accompanied by weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate during weight loss, we compared two weight loss diets with different carbohydrate levels for the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus for at least one year
* hgba1c \> 6.0
* BMI from 27-50 kg/m2

Exclusion Criteria:

* Unstable medical condition
* Serious medical condition
* AST or ALT \> 100
* Serum creatinine \> 1.5
Epidemiological EMESIS-Registry

The purpose of this registry is to record information on reality of anti-emetic therapies of cancer-patients in Germany. The outcome of this study is the efficacy of anti-emetic therapies dependent on the rate "complete and major control" of nausea and emesis in moderately and highly emetogenic chemotherapies, consisting of platin-derivates (cisplatin, carboplatin and oxaliplatin), anthracyclines and/or cyclophosphamid.


Eligibility Criteria:
Inclusion Criteria:

* Moderately or highly emetogenic chemotherapy consisting of platin-derivates (cisplatin, carboplatin and oxaliplatin), anthracyclines and/or cyclophosphamid.
* start with the 1st cycle of the regimen (chemo naive patients). Inclusion of pretreated patients is also possible, if the last treatment cycle of a previous chemotherapy was given \>= 24 months ago.
* Compliance with registry procedures
* Age \>= 18 years
* WHO Performance Status of 0 or 1 (Karnofsky-Index \>= 70%)
* Life expectancy of at least 12 weeks
* Signed and dated informed consent before the start of the registry

Exclusion Criteria:

* Mentally incapable or incompliant patients
* Last chemotherapy \<= 24 months (if pretreated)
* Known hypersensitivity to antiemetic medication
* unability of the patient to be treated with oral medication
* pregnancy or lactation period
Complexity & Distraction in LBP

Motor control, notably expressed through the complexity of the variability of the locomotor pattern, is disturbed at the central level by an apprehension of pain and movement, more than pain itself (or by biomechanical / structural damage of the spine) in chronic low back pain (cLBP) patients.

The aim of this study is to control that variability is reduced during gait at comfortable level and to test that distraction can reduce pain avoidance and therefore increase variability in cLBP patients.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have his informed consent and signed the consent form.
* The patient must be affiliated or beneficiary of a health insurance plan
* The patient is at least 18 years old and under 75 years old
* Patients with common chronic low back pain for more than 6 months

Exclusion Criteria:

* The subject participates in another interventional study
* The subject is in an exclusion period determined by a previous study
* The subject is under the protection of justice, guardianship or curatorship
* The subject refuses to sign the consent
* It is impossible to inform the subject
* Chronic symptomatic low back pain (tumoral pathology, infectious, or progressive inflammatory)
* Unable to walk for more than 10 minutes (during interrogation)
* Lower limb pain (EVA lower limb (s) ≥ Lumbar EVA)
Project PREVAM : Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy

The aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and a high resolution colonoscope (with high definition). Both procedures will be perform in the same day with an adapted bowel preparation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Patient with 40 years old and first degree relative affected by colo rectal cancer at age ≥ 60 ans
* Patient with 40 years old or ten years before the age at affected disease in case or first deree relative colo rectal cancer before 60 years old.
* Fecal occult blood test positive
* Personal history of adenomatous polyps
* Personnal history of acromegaly
* Patient with social insurance
* Persons already participating in another clinical trial..
* Signature of informed consent

Exclusion Criteria:

* Pregnancy or breast feeding woman
* Déficience mentale du sujet rendant sa participation à l'essai impossible
* Pacemaker or all electronic devices implanted
* Patient with swallowing disorder, or digestive stricture know or suspected by the investigator
* Previous history of intestinal surgery, radiotherapy or inflammatory bowel disease
* Previous history of polyadenomatous congenital disease, Lynch syndrome
* Intolerance with dompéridon and/or bisacodyl
* Intolerance with oral intake of NaP, polyethylen glycol (PEG) or macrogol
* Colonoscopy contre indication for anesthesiologic reasons
Oxytocin, Couple Interaction and Wound Healing

effects of intranasal oxytocin and couple interaction on wound healing.

* Trial with medicinal product


Eligibility Criteria:
Inclusion criteria:

* healthy heterosexual couples
* in a stable relationship since \> 1 year

Exclusion criteria: pregnancy

* breast feeding
* heavy smoking (\> 5 cigarettes/d)
* extensive skin disease
* artificial UV irradiation during \< 3 months before study inclusion
Prepubertal Children With Growth Failure Associated With Primary Insulin-Like Growth Factor-1 (IGF-1) Deficiency

This study is intended to determine whether twice daily weight based dosing with recombinant human insulin-like growth factor (rhIGF-1) will safely and effectively increase the growth of prepubertal children with short stature associated with low IGF-1 levels but who produce sufficient growth hormone (GH). Subjects will be randomized to either an observation arm or to active treatment.

Prepubertal growth failure associated with primary IGF-1 deficiency (IGFD). Primary IGFD is a term that has been used to describe patients with intrinsic cellular defects in GH action. In this protocol, primary IGFD is defined as short stature (height standard deviation score\[SDS\]\<-2 below the mean for age and gender), low serum IGF-1 (IGF-1 SDS \<-2 below the mean for age and gender), and levels of growth hormone (GH) that are normal (≥7ng/mL) after a GH stimulation test. Primary IGFD is believed to result from a lower than normal ability to produce IGF-1 when exposed to normal levels of GH, i.e., a type of GH insensitivity or GH resistance.

This trial is one year, randomized, open label, observation-controlled, parallel-dose comparison efficacy and safety study conducted in approximately 40 centers across the United States.

Eligibility Criteria:
Inclusion Criteria:

* Chronological age ≥ 3 and chronological or bone age less than or equal to 11 years inclusive in girls;
* Chronological age ≥ 3 and chronological or bone age less than or equal to 12 years inclusive for boys
* Prepubertal
* Height SD score of \< -2
* IGF-1 SD score of \< -2

Exclusion Criteria:

* Prior treatment with rhGH, rhIGF-1, or other growth-influencing medications
* Growth failure associated with other identifiable causes (e.g., syndromes, chromosomal abnormality)
* Chronic illness such as diabetes, cystic fibrosis, etc.
Safety Dermatological Assessment of Topical Use Product Through Dressings Predictive Studies for Evaluation of Photoirritation and Dermal Photosensitivity

The purpose of this study is to prove the product tested does not cause photoirritation or photosensitization reactions when exposed to sun light.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 70 years old;
* Skin types: I (light caucasian) or III (light brown);
* Intact skin where the product will be applied;
* Agreement to comply with the test procedures and attend the clinic in the days and fixed times for medical assessments and application and reading of dressings
* Signature of informed consent form

Exclusion Criteria:

* Pregnancy and lactation
* Use of anti-inflammatory and immunosuppressive from 30 days up to three months prior to selection;
* Diseases that cause immune suppression;
* Use of photosensitizing drugs;
* History or photodermatoses activities;
* Personal or family history of photoinduced skin cancer;
* Presence of precursor lesions of skin cancer, such as melanocytic nevi and actinic keratoses;
* Intense sun exposure in the experiment area Use of new drugs and/or cosmetics during the experiment;
* Previous participation in a study with the same product under test;
* Relevant medical history or current evidence of alcohol or other drugs abuse;
* Known historical or suspected intolerance to any ingredient of the product under study (product under test or comparator);
* Sponsor's employees involved in the study, or close family member of an employee involved in the study;
Treatment of Atrial Fibrillation in the Community Settings

Description of treatment of cardiovascular diseases in community settings in Russia

The study will describe different treatment modalities used in management of cardiovascular diseases in community hospital in small town of Tarusa in Russia. This part of the study will focus on atrial fibrillation and its treatment.

Eligibility Criteria:
Inclusion Criteria:

* all patients undergoing direct current cardioversion for atrial fibrillation or flutter

Exclusion Criteria:

* none
A Study Comparing Non Myeloablative (Flu-TBI) and Reduced Intensity (FLU-BU-ATG) Conditioning in Allogenic Transplantation

This study is a prospective comparison between 2 popular regimens based on reduced intensity or non-myeloablative approaches to define the optimal myeloablative and/or immu-nonsuppressive association for reduced intensity conditionings (RIC).

Flu-Bu-ATG (Study A) associated Fludarabine (30mg/m²/5 days), Oral Busulfan (8 mg/kg over 2 days) and Thymoglobuline (2.5 mg/m²/1day).

Flu-TBI (Study B) consisted of Fludarabine (25mg/m²/ 3 days) and 2 Gy total body irradiation (TBI).

A randomization of 2 phase study according to the methodology developed by Liu et al (Liu, 1993 and 2001) for the evaluation of multiple innovative approaches.

Primary endpoint is one year overall survival (OS). Stopping rules included excessive engraftment failure and trans-plant related mortality ratio. Data are yearly reviewed by an independent safety review board (ISRB).

Inclusion criteria are patients presenting a hematological malignancy, eligible for non myeloablative allo stem cell transplantation (SCT), aged between 18 and 65, with a suitable HLA identical sibling. All patients and donors are included after giving written informed consent.

Protocol was submitted and accepted by the ethical committee and the AFFSSAPS cellular therapies committee (national agency).


Eligibility Criteria:
Inclusion Criteria:

* hematological malignancy or solid tumor,
* eligible for non myeloablative allogenic transplantation,
* aged between 18 and 65,
* with a suitable HLA identical sibling

Exclusion Criteria:

* contra-indication to allogenic transplantation
* pregnant women or breast feeding
* active infection