cyrilzakka/clinical-trials huggingface dataset:
National Clinical-biological Prospective Cohort of Incident Cases of Aggressive Fibromatosis (ALTITUDES)

The purpose of this study is to constitute the French largest Aggressive fibromatosis cohort.

Aggressive fibromatosis (AF) is a rare non-metastasizing connective tissue tumor (\< 300 cases/year in France), associated with high risk of local relapse, functional impairment and pain. AF can occur at any age, but most commonly between 25 and 40 with a significant female predominance. AF is most frequently (about 85%) sporadic and then associated with a somatic mutation of the CTNNB1 gene. AF is associated with heredity condition, as complication of familial adenomatous polyposis (with germinal mutation of Adenomatous polyposis coli (APC) gene). Most of AF arises on lims or abdominal wall. Nevertheless, some particular locations are life-threatening (mesenteric or cervical locations). The natural course of AF is unpredictable. One third of tumors are spontaneously stable. One third of tumor spontaneously decreases. One third of tumor is progressive, with a non-linear tumor growth dynamic. As the consequence the decision making for starting curative intent treatment is difficult, since some treatment could be mutilating (large en bloc surgery) or associated with late and severe complications (radiotherapy) and since these treatments could fail to control this benign tumor. Therapeutic options are: wait-and-see policy, surgery (sometimes mutilating), radiotherapy or systemic treatment (non-steroidal anti-inflammatory drugs, hormonotherapy, imatinib, chemotherapy). Level of evidence associated these options is very low, based on retrospective studies and rare non-randomized phase II clinical trials.

Regarding these uncertainties, physicians can hardly answer to patient questions.

Prospective data provided by a large multi-center cohort is needed. The objective of the present study is to create a large cohort of incident cases of AF associated with tumor bank and collection of blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Incident Case of aggressive fibromatosis in France, diagnosed after 01/01/2016
* Confirmed diagnosis by the French anatomopathological diagnosis network (including search for mutation of the β-Catenin Gene, CTNNB1)
* Affiliation to the National Health System
* Informed consent signed (both parents signature for non adult patients)

Exclusion Criteria:

* Administrative or legal measure of liberty privation
* Patient not able to give consent or unwilling to provide consent
Androgen Effects on the Reproductive Neuroendocrine Axis

This research study investigates whether male-level exogenous androgens inhibit the reproductive neuroendocrine axis in otherwise healthy (non-PCOS) females.

Testosterone Replacement Therapy (TRT) is the mainstay of gender affirming care for transgender men (TGM) who have male gender identity after female sex assignment at birth. TGM receiving TRT over time exhibit irregular menstrual bleeding, however, the mechanism of menstrual disruption is unknown. Therefore, the investigators propose to evaluate the effect of chronic testosterone (T) exposure on ovarian hormones and pituitary gonadotropin release that determines menstrual cyclicity. The investigators will conduct a detailed study of blood reproductive hormone secretion in TGM before and during TRT as well as in untreated cisgender female (CGF) control subjects who report female gender identity congruent with female sex assignment at birth. The investigators will also perform periodic clinical and ultrasonographic evaluations.

Eligibility Criteria:
Inclusion Criteria: Transgender/Non-binary Group, Initiating Testosterone Group

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Aged 18-35
* Plan to initiate testosterone therapy
* History of regular menstrual cycles (every 24-35 days) at baseline, before beginning TRT

Inclusion Criteria: Cisgender Female Group

* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Aged 18-35
* Having regular menstrual cycles (every 24-35 days)

Exclusion Criteria: All

* Pregnant
* Incarcerated
* Known cognitive impairment or institutionalized
* Hemoglobin less than 11 gm/dl at screening evaluation
* Weight less than 110 pounds
* BMI \<18 or \>35
* Current endocrine disease- including untreated thyroid abnormalities, pituitary or adrenal disease, polycystic ovary syndrome, or androgen producing tumor
* Current or recent pregnancy within two months of study enrollment
* Current or recent breast feeding within two months of study enrollment
* Diabetes, or renal, liver, or heart disease
* History of oophorectomy or hysterectomy
* History of radiation or surgery involving brain structures and/or pelvis/pelvic organs
* Currently taking any medications that may affect their reproductive hormones, such as contraceptive medications, androgens, estrogens, progestins, GnRH antagonists, GnRH agonists, insulinomimetics, and metformin.
* History of prior testosterone therapy
The Effect of Honey on Lessening the Withdrawal Symptoms

This project investigates the effect of honey on lessening the withdrawal symptoms according to the body constitution.


Eligibility Criteria:
Inclusion Criteria:

* the cessation clinic patients aged more than 18
* only take Champix for smoking cessation

Exclusion Criteria:

* diabetes, cancer, renal disease
* with wet and hot body constitution
* allergic to honey
* accepting traditional Chinese medicine intervention
Diabetes Remote Intervention to improVe Use of Evidence-based Medications

A randomized remote, implementation trial in the Mass General Brigham network was performed on 200 patients with T2D at high CV or kidney risk. The study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months.

A randomized remote, implementation trial in the Mass General Brigham network performed on 200 patients with T2D at high CV or kidney risk. Patients eligible for, but not prescribed, SGLT2i or GLP-1 RA were randomly assigned to 1) simultaneous patient education and medication initiation "simultaneous" arm or 2) 2-months of education followed by medication initiation "education-first" arm. A multi-disciplinary team provided education and prescribed GDMT using a treatment algorithm. The study's primary objective was to create a remote diabetes management platform that improved the initiation and adherence to glucose-lowering medications with CV and kidney benefit and was evaluated by the primary outcome: increasing the proportion of patients with prescriptions for GDMT therapy by 6 months. Secondary objectives included the primary outcome by randomization arm, prescribed therapy by 2 months, and patients taking prescribed therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 27 - 79 years at the time of agreeing to participate in the program
2. Presence of type 2 diabetes (treated with metformin unless intolerant, may also be treated with DPP4i, sulfonylurea, pioglitazone, and/or basal insulin)
3. HbA1c 6.5-8.9%; AND
4. At elevated cardiovascular and/or renal risk defined as any diagnosed ASCVD, estimated ASCVD risk \>10%, congestive heart failure, non-alcoholic fatty liver disease, estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2, albuminuria above 300mg/g; and those aged 60 years or older with at least two of: active tobacco use, dyslipidemia (LDL-c above 160 mg/dL or 4.1 mmol/L, non-HDL-C above 190 mg/dL or 4.9 mmol/L, triglycerides above 175 mg/dL,) hypertension (2 systolic blood pressure values above 130 mmHg and/or 2 diastolic blood pressure values above 90 mmHg within 12 months,) or BMI above 30
5. Has seen a primary care provider within the Mass General Brigham network within the last year

Exclusion Criteria:

1. Type 1 diabetes
2. Currently or previously prescribed an SGLT2i or GLP1-RA
3. Taking any short-acting insulin
4. History of diabetic ketoacidosis
5. History of hypoglycemia requiring hospitalization
6. Frequent (more than two times in 1 week) episodes of symptomatic hypoglycemia with blood glucose \<70 mg/dL
7. eGFR below 15 ml/min/m2
8. Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation, OR
9. Life expectancy less than 1 year or utilizing palliative care
Pulses of Vincristine and Dexamethasone in BFM Protocols for Children With Acute Lymphoblastic Leukemia

Studies in the 1970s and 1980s suggested that the outcome of childhood acute lymphoblastic leukemia could be improved by intensification of conventional continuation chemotherapy with pulses of vincristine sulfate and steroids. We aimed to investigate the efficacy and toxic effects of vincristine-dexamethasone pulses as an addition to the continuation-therapy phase in a large cohort of children with intermediate-risk disease who were treated with the BFM treatment strategy

The study enrols children from 8 participating organizations. All children are treated with similar protocols based on the BFM treatment strategy, which include induction, consolidation, reinduction and continuation-therapy phases. At the beginning of the continuation-therapy phase, those patients in complete remission are randomly assigned to either a treatment or a control group. Control patients are given conventional mercaptopurine and methotrexate chemotherapy only. Patients in the treatment arm are also given pulses of vincristine (1.5 mg/sqm weekly for 2 weeks) and dexamethasone (6 mg/sqm daily for 7 days) every 10 weeks for six cycles.

Eligibility Criteria:
Inclusion Criteria:

* age \<1 or \>5 years or
* white blood cell count at diagnosis \>=20000

Exclusion Criteria:

* prednisone poor response
* no complete remission at the end of induction (IA)
* t(9,22) clonal translocation
* t(4,11) clonal translocation
Rasburicase for Hyperuricemia

Primary: To estimate efficacy of SR29142 to the pediatric patients with newly diagnosed hematological malignancies at high risk for Tumor Lysis Syndrome, by evaluation of plasma uric acid concentration.

Secondary: To investigate the safety in this population and anti-SR29142 antibodies, anti-SCP antibodies, and pharmacokinetic parameters.


Eligibility Criteria:
Inclusion Criteria:

* \<18 years of age
* Patient with newly diagnosed hematological malignancies presenting with hyperuricemia:
* Uric acid \> 7.5 mg/dL in patients ≥ 13 years old- Uric acid \> 6.5mg/dL in patients \<13 years old

Or, patient with newly diagnosed hematological malignancies presenting with high tumor burden defined:

* Non-Hodgkin's lymphoma, Stage IV regardless of uric acid level,
* Non-Hodgkin's Lymphomas stage III regardless of uric acid level with one of the following:

  * At least one lymph node or mass \>5 cm in diameter
  * LDH ≥ 3 x ULN (IU/L): Judging according to modified Murphy's classification
* Acute leukemia with white blood cell count (WBC) ≥ 50,000/mm3 or LDH ≥ 3 x ULN (IU/L) regardless of uric acid level. etc.

Exclusion Criteria:

* Patients who have received or are scheduled to receive other investigational drugs in 30 days prior to the start of SR29142 administration or during the trial period.
* Low birth weight infant (\<2500g) or gestational age \<37 weeks
* Patients who have received or are scheduled allopurinol within 72 hrs prior to the first dose of SR29142 or during the trial period.
* Known history of severe allergic reaction and/or severe asthma.
* Known history or family history of glucose-6-phosphate dehydrogenase deficiency.
* Known history of hemolysis and methemoglobinemia.
* Severe disorders of liver or kidney. ALT (GPT) \> 5.0 x ULN, Total Bilirubin \> 3.0 x ULN, Creatinine \> 3.0 x ULN
* Uncontrollable infections (including viral infections).
* Known positive tests for HBs antigen, HCV antibodies, or HIV-1, 2 antibodies. etc.
Impact of Oligonol to Cardiometabolic Risk and Muscular Health

This project will mainly focus on Middle and old-aged adults, and examine whether Cardiovascular and metabolic risks can be reduced. In the meanwhile, this project will develop strategies for improving muscle loss , muscle strength decline, and the quality life of the elderly.

Cardiovascular diseases are common among the elder. However, previous researches mainly focus on observational research or small scale clinical trial, and the subjects are mainly youth. Therefore, this project hope to understand whether Oligonol can reduce Cardiovascular and metabolic risks among senior adults. Consequently,improve muscle loss muscle strength decline, quality of old adults life. This project design may potentially develop new strategies for curing Sarcopenia as well.

Eligibility Criteria:
Inclusion Criteria:

* People who aged more than 50 years
* Patients with following characteristics:
* feeling loss in activity.
* detecting decline in self's walking speed.
* feeling tired of doing everything.
* having fallen down last year.
* People can accept undergoing MRI
* People willing to follow the program and cooperate with us for following tracking.
* People who are neither vegan nor vegetarian

Exclusion Criteria:

* Walking speed less than 0.3m/s
* People with any disease affecting their limbs, including:
* having fracture on limbs in the past 6 months.
* having severe arthritis in the past 6 months
* any other whom PI recognized as weak control of their nervous system( e.g.: Parkinson's disease and stroke).
* People with intermittent limp caused by peripheral artery diseases
* People with weak control of mental disorder
* People with weak control of Cardiopulmonary disease
* People with weak control of Malignant tumor
* People with weak control of kidney diseases (GFR \< 30 mL/min/1.73 m2 for at least 3 months)
* People with visual impairment and hearing disorder who cannot complete the program.
* People who are unable to undertake MRI
* Any other condition that PI recognized as not suitable.
Evaluation of Adipose Derived Stem Cells Exo.in Treatment of Periodontitis

The adipose stem cells exosomes will be extracted from adipose stem cells isolated autogenously from the patient to be injected locally into the periodontal pockets in order to evaluate their regenerative effect.


Eligibility Criteria:
Inclusion Criteria:

* Advanced periodontitis (Stage III or IV)
* Healthy patients.

Exclusion Criteria:

* Smokers, Diabetic, Pregnant ladies, Under corticosteroids or contraceptive treatment,poor oral hygiene.
Influence of Hyperbilirubinaemia on Two Different Near Infrared Spectroscopy Devices

Protocol Near infrared spectroscopy liver transplants: comparison of two monitoring of Near infrared spectroscopy in pediatric liver transplant.

Hyperbilirubinaemia may interfere with oximetry values as measured by Near Infrared Spectroscopy devices. The number of wave lengths used by different devices can influence the oximetry values in adult patients. This has never been demonstrated in children with hyperbilirubinaemia scheduled for elective liver transplantation.The study will compare cerebral and somatic oximetry values measured by two different Near infrared spectroscopy devices (FORESIGHT and INVOS) and analyse the influence of bilirubin levels on these differences.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients 0 to 18 years, with a liver transplant with living donor program of our institution
* Free, informed and written consent signed by the investigator or employees and by the legal guardians of minor patients in the days preceding the procedure

Exclusion Criteria:

* refusal of the patient or his parents to consent
* known brain or Neurological pathology
Suramin in Treating Patients With Recurrent Primary Brain Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of suramin in treating patients with recurrent primary brain tumors following radiation therapy.

OBJECTIVES: I. Estimate the efficacy of suramin in patients with recurrent primary brain tumors as measured by radiographic response, time to progression, and survival. II. Assess the toxic effects of suramin in this patient population.

OUTLINE: Single-Agent Chemotherapy. Suramin, SUR, NSC-34936.

PROJECTED ACCRUAL: If at least 1 of the first 14 patients experiences at least a partial response, a total of 25 patients will be entered over approximately 30 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Recurrent brain tumor based on one of the following: Tissue diagnosis if there was a prior diagnosis of astrocytoma or oligodendroglioma or if there is a question of radiation necrosis from prior interstitial brachytherapy Metabolic activity in excess of normal cortex measured by 18-fluorodeoxyglucose uptake on PET One of the following histologic types required: Glioblastoma multiforme Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed glioma Tumor progression required, i.e.: 28% increase in contrast-enhancing area or 50% increase in contrast- enhancing volume over at least 4 weeks Measurable disease required No history, surgical findings, or radiographic signs of intratumoral hemorrhage

PATIENT CHARACTERISTICS: Age: Over 15 Performance status: Karnofsky 50%-100% Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000 Platelets at least 75,000 Hepatic: Bilirubin less than 1.5 mg/dL AST/ALT less than 3 times normal No history of bleeding disorder No hepatic disease resulting in hospitalization Renal: Creatinine less than 1.5 mg/dL No renal disease resulting in hospitalization Cardiovascular: No ongoing anticoagulation for deep vein thrombosis (DVT) No residual symptoms from DVT after discontinuation of anticoagulation No cardiac disease resulting in hospitalization Pulmonary: No pulmonary disease resulting in hospitalization Other: No peripheral neuropathy of any etiology HIV negative No pregnant or nursing women Adequate contraception required during and for 12 months following protocol therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for glioblastoma multiforme No more than 1 prior chemotherapy regimen for anaplastic astrocytoma, malignant oligodendroglioma, or malignant mixed glioma At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin) Endocrine therapy: Not specified Radiotherapy: Completion of 1 course of conventional external radiotherapy required At least 4 weeks since radiotherapy Surgery: Decompressive surgery for clinically suspected increased intracranial pressure performed prior to entry
One-year Outcomes in Survivors of the Severe COVID-19 Pneumonia (CO-Qo-ICU)

Many of the patients hospitalized for a severe form of SARSCoV-2 respiratory impairment require prolonged intensive care that can be complicated in the short term, In the medium and long term, physical and psychological sequelae can affect patients' quality of life and prevent a return to normal working life.

To date, there is little data on the fate of patients treated in Resuscitation for a severe form of COVID-19, both in terms of respiratory sequelae, as well as in terms of psychological sequelae and their quality of life. The objective of this study is to be able to describe and evaluate the possible physical and psychological sequelae and quality of life of patients hospitalized in Resuscitation for a severe form of COVID-19 in the short (3 and 6 months), medium (1 year) and long (5 years) End of their stay in ICU. To do this, we want to carry out a prospective, observational and monocentric study in the consultation department of the Nice CHU. All patients admitted to Resuscitation for a severe form of COVID-19 who have accepted the longitudinal medical follow-up proposed by the Nice CHU will be included in the study and data from the computerized medical record will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized in ICU for an ARDS table
* PCR SARSCoV-2 nasopharyngeal or positive pulmonary samples
Epidural and Spinal Anesthesia Techniques in Pilonidal Dermoid Sinus Surgeries

Pilonidal dermoid cyst surgery under general anesthesia and regional anesthesia techniques is used.regional anesthesia techniques; spinal, epidural, spinal epidural (combined) and is the local anesthesia.In the investigators study, pilonidal dermoid cyst surgery in spinal and epidural anesthesia techniques activity, reliability will be compared to the side effects and complications.

One hundred patients will be randomly assigned to either the pilonidal dermoid cyst under Spinal anaesthesia (50 patients)(Group 1) or pilonidal dermoid cyst under epidural anaesthesia (50 patients)(Group 2). Group 1 will be used in spinal catheter in spinal anesthesia procedures or Group 2 will be used epidural catheter in epidural anaesthesia procedures.All patients has symptomatic pilonidal dermoid cyst.

Pilonidal dermoid is a tubular skin defect which can be seen in both female and male patients between the ages of 12 to 80. Treatment alternatives includes surgical excision. During the surgical treatment local, general, spinal or epidural anesthesia could be applied. However, local anesthesia usually is not preferred due to the fact that pilonidal dermoid sinuses depth, width could not be determined precisely. General anesthesia also is not preferred due to the fact that difficulties arising from patient's positioning and positioning based potential lung related problems. In general, spinal anesthesia and epidural anesthesia is preferred for pilonidal dermoid sinus surgeries. In this study, the investigators will demonstrate advantages, disadvantages, complications, (sensory and motor block levels), and durations of spinal and epidural anesthesia and superiority of each on these subjects.

Patients who are over 18 and have a America Society of Anesthesiologist (ASA) physical score of I and II will be included in the study. Patients who are pregnant, have a known allergic reactions to local anesthetic and have contraindications against spinal and epidural anesthetic will be excluded from the study.

In this study the investigators separate the patients into 2 groups. Group1: pilonidal dermoid cyst under Spinal anaesthesia (50 patients).Group 1 will be used in spinal catheter in spinal anesthesia procedures ; Group2:pilonidal dermoid cyst under epidural anaesthesia (50 patient).Group 2 will be used epidural catheter in epidural anaesthesia procedures. All patients has symptomatic pilonidal dermoid cyst

Eligibility Criteria:
Inclusion Criteria:

* America Society of Anesthesiologist (ASA) physical score of I and II
* the men and women over the age of 18, pilonidal sinus disease

Exclusion Criteria:

* Pediatric patients
* Pregnant women
* Patients with bleeding disorder
* Patients with spinal deformity