cyrilzakka/clinical-trials huggingface dataset:
Midostaurin in Indolent Systemic Mastocytosis

Rationale: Patients with indolent or smoldering systemic mastocytosis can have severe disabling symptoms. Almost all patients have fatigue, a compromised quality of life, hampering normal functioning. Because this form of mastocytosis is not considered life-threatening, mast cell eradication has never been applied and patients receive only symptomatic therapy with histamine blockers. Midostaurin, a c-KIT inhibitor has shown activity regarding symptom control and decrease of malignant mast cells in patients with aggressive systemic mastocytosis (ASM) or mast cell leukemia

Objective:

Primary: To study in a pilot phase II trial the efficacy of midostaurin administered at an oral dose of 100 mg twice daily in patients with indolent or smoldering systemic mastocytosis on mediator symptom reduction, documented by the Mastocytosis Symptom Assessment Questionnaire, measured at 3 months.

Secondary:

1. To study whether symptom improvement persists at 6 months, and whether midostaurin can reduce mast cell infiltration in the skin and bone marrow, documented by decrease of serum tryptase, decrease of urticaria pigmentosa and decrease of bone marrow mast cells.
2. To assess safety and tolerability of midostaurin in the above mentioned settings

Study design: Single arm, open label pilot phase II study.

Study population: Adult patients (n=20) with histologically documented systemic mastocytosis, indolent or smoldering subtype, with severe symptoms, not controlled by histamine 1 and 2 blockers.

Intervention: treatment with Midostaurin, twice daily 100 mg orally for 6 months continuously.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Indolent Systemic Mastocytosis (ISM) or Smouldering Systemic Mastocytosis (SSM) according to the WHO criteria
* Presence of the D816V c-KIT mutation
* Serum tryptase \> 20 mg/l
* Serious mediator-related symptoms that cannot be controlled by H1 and H2 blocking drugs. Symptoms will be scored by an adapted MSAF (mastocytosis symptom assessment form) with at least:

  * a pre-study score of 4 or more on 3 non-related items,
  * or a pre-study score of 5 or more on 2 non-related items.
  * one item from the scoring list can be replaced by flushes 7 or more per week or anaphylactic attacks 1 or more per week.
* Age \>18 years
* Willingness to apply optimal contraceptive measures (double barrier method, both men and women) for women below the age of 55, men at all ages; for both: if sexually active.
* Written informed consent

Exclusion Criteria:

* Aggressive systemic mastocytosis, mast cell leukemia, or ASM with or without accompanying non-clonal related non-mast cell disorder (SM-ANHMD).
* Any known other present malignancy, non-melanoma skin cancers excluded
* History of malignancy within the last 5 years, non-melanoma skin cancers excluded
* Any serious comorbidity interfering with therapy compliance and follow-up compliance
* Pregnancy
* Patients not willing or who are not able to comply with contraceptive measures
Long-term Comparative Cerebrovascular Outcome After Transplantation vs Standard Care in Sickle Cell Anemia

The purpose of the present observational study is to remotely reevaluate the cohort of 67 sickle cell patients with transcranial Doppler-detected cerebral vasculopathy included in the national "Sickle Cell Transplant" protocol and whose 1- and 3-year results were published in JAMA (Journal of the American Medical Association) in 2019 and in BHJ in 2020.

The present observational study has the objective to reevaluate at distance the cohort of 67 children with sickle cell anemia enrolled in the "Drepagreffe"trial because of cerebral vasculopathy detected by transcranial Doppler. Results at 1 and 3 years were reported in JAMA in 2019 in BHJ in 2020. This trial was the first worldwide prospective study comparing transplantation to standard care in sickle cell disease. Velocities were highly significantly more reduced with a higher proportion of patients with normalized velocities and better quality of life after transplantation than on standard care. Despite a trend to a better ischemic lesions outcome at 3 years, the difference was not significant and cognitive performances were not different between both groups. The biologic study only assessed at enrollment and 1-year showed lower levels of Ang-2 and HGF (hepatocyte growth factor) after transplant and a significant and independent association between Doppler normalization probability with low Ang-2 and BDNF (brain-derived neurotrophic factor) levels.The aim of the present study is to reassess at 9-10 years this cohort with grants allowing to reevaluate cognitive functioning and hypoxia/angiogenic factors not realized in the systematic cohort follow-up

Eligibility Criteria:
Inclusion Criteria:

* Patient of legal age or minor who participated in the DREPAGREFFE research protocol \[NCT 01340404\] between December 2010 and June 2013,
* Having read and understood the information letter

Exclusion Criteria:

* Refusal to participate
* Patient deceased
Prediction of Lymph Node Status in Stage T1 Esophageal Squamous Cell Carcinoma（RENMIN-237）

Accurate assessment of lymph node status in superficial esophageal squamous cell carcinoma is of great significance for preventing undertreatment and overtreatment. However, the accuracy of the commonly used preoperative imaging methods for evaluating lymph node status is not high, and it is urgent to develop a prediction model that can predict the risk of individual lymph node metastasis to assist in clinical decision-making. In this context, investigators intend to retrospectively collect the clinical and pathological data of 300 patients with superficial esophageal squamous cell carcinoma, construct a lymph node metastasis risk prediction model. In addition, investigators are also preparing to prospectively collect tissue samples from 30 patients with superficial esophageal squamous cell carcinoma to further explore the mechanism of lymph node metastasis.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with esophageal cancer in Renmin Hospital of Wuhan University from 2013 to 2022.
2. Histopathological diagnosis was squamous cell carcinoma.
3. T1NxM0.
4. Received endoscopic resection or esophagectomy.

Exclusion Criteria:

1. Patients who received neoadjuvant therapy.
2. Positive surgical margin.
3. Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured.
4. Lack of complete histopathological information.
Diagnosis and Prediction of Pre-Eclampsia by Using Congo Red Dot Test in Bangladesh and Mexico

A cross sectional study design will evaluate the diagnostic value of the CRD test to the pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán, tertiary level facilities in Bangladesh and Mexico City.

A cross sectional study design will evaluate the diagnostic value of the Congo Red Dot test to the pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán, tertiary level facilities in Bangladesh and Mexico City. Women attending the hospital with clinically confirmed cases of preeclampsia and clinically healthy women who deliver at term will be eligible for the study. Investigators will enroll about 200 women at each facility. Investigators will target the following women for enrollment: women with clinical diagnosis of preeclampsia (severe, mild or superimposed) (n=100); and clinically healthy women who deliver at term (n=100). The purpose of the research is to determine the clinical utility of congophilia (affinity for the dye Congo Red) in the diagnosis and prediction of preeclampsia. Investigators will determine the diagnostic value of this test by testing the urine sample provided to determine the presence or absence of proteinuria or congophilia.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Willing to provide a urine sample
* Eligible to consent to research according to local laws and regulations
* Present with a clinical diagnosis of preeclampsia (severe, mild or superimposed) OR clinically healthy and delivering at term

Exclusion Criteria:

-None
Minimum Effective Volume of Lidocaine-Bupivacaine for Subgluteal Block

The aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block.

The aim of this study is to determine the minimum effective volume of LA in 90 % of patients (MEV90) required for US-guided subgluteal sciatic nerve block.

Success rate is defined as a minimal composite score of 6 points (out of 8 points) at 30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 75 years
* American Society of Anesthesiologists classification 1-3
* body mass index between 20 and 35

Exclusion Criteria:

* adults who are unable to give their own consent
* pre-existing neuropathy (assessed by history and physical examination)
* coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
* renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
* hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
* allergy to LA
* pregnancy
* prior surgery in the subgluteal region
* chronic pain syndromes requiring opioid intake at home
Pre-hospital Advanced Airway Management Studying Expedited Routines

In the Scandinavian and Swiss HEMS critical care teams, the prehospital tracheal intubations (TI) are performed by airway experts with high success rates and low rates of complications. Due to environmental conditions these are today frequently performed in-cabin before take-off. There are so far no published data on comparing outside and in-cabin TI under these circumstances.

This will therefore be the first prospective study comparing prehospital TIs outside or incabin, performed by airway experts.

Background Seriously ill or injured patients might require prehospital TI, which is a potentially lifesaving intervention. Performing TI in a prehospital context differ from the preconditions inhospital due to environmental and technical aspects and resources available (3). Today there is a consensus that prehospital critical care should at least be on the same standards as in-hospital care. The trend therefore has been towards more rigorous safety precautions introducing Standard Operating Procedures (SOP) including 360oaccess to patients with all equipment at close hand brought out from the helicopter or the ambulance and long challenge-response lists. This will shift focus towards adherence to SOPs instead of tailoring the sequence of procedures according to circumstances and patient needs. An experienced operator can plan and communicate appropriate actions from a risk-benefit perspective in a stressful situation. Prehospital interventions have to be time effective, especially where short on-scene times are preferable in time-critical conditions such as uncontrolled internal haemorrhage and traumatic brain injuries.

A recent Nordic multicentre study, PHAST, shows that emergency systems staffed with highly experienced anaesthetists can perform prehospital TI with high success rates, low incidence of complications and short on-scene times. Due to environmental factors, weather and light conditions in the Scandinavian countries, it is not always favourable to perform TI outside the helicopter or ambulance, with 360o -access. Technical aspects in-helicopter/in-ambulance such as access to better suctioning and stretcher positioning, can influence the operator's decision on where to perform the TI. Whether the location of the TI affects the outcome has not yet been studied. A recent experimental mannequin study, SPRINT, suggests that in-cabin intubations can offer equal to, or even better conditions than out of cabin and can shorten on-scene time. To investigate whether this applies to real life conditions, a prospective large-scale clinical study must be done.

Performing prehospital TI is dependent on a well-functioning team where the operator has an assistant backing up during the procedures. The assistants' level of airway experience and the teams' accumulated experience working together has not been studied earlier.

Eligibility Criteria:
Inclusion Criteria:

* Patients in need of prehospital drug-assisted intubation.

Exclusion Criteria:

* All cases where prehospital TI is performed without the use of any drugs.
Clinical Investigation Comparing Two Different Ultra-porous Coated Surfaces of Uncemented Cups

A randomised controlled study comparing two types of ultra-porous coated uncemented cups in total hip arthroplasty. Primary objective is to investigate if the clinical, radiological and patient-reported outcome of the new MobileLINK TabecuLINK cup combined with an X-LINKed insert is non-inferior to the clinical and radiological outcome of the Pinnacle Gription series 100 cup combined with the Marathon liner. Patients are evaluated up to 15 years postoperatively.

The purpose of this study is to evaluate the clinical outcome and long-term risk of development of osteolysis of a newly introduced cementless press-fit acetabular cup, consisting of a shell with a 3D surface structure and a highly cross-linked liner by precise measurement of early migration and wear.

Migration describes the movement between the implant and the surrounding bone over time. Early migration of the implant, within 2 years after operation, has shown to be a strong predictor for increased risk for late failure. Thus, high precision migration studies can be used to evaluate the performance of new implants in small groups of patients with a relatively short observation time. Wear particles are one of the main causes of periprosthetic osteolysis. Although modern, more wear resistant materials, appears to have a greatly reduced risk of osteolysis, the desired complete elimination of osteolysis appears to be yet unachieved. It is most likely that the mechanism of periprosthetic osteolysis is multifactorial.

In this study the investigators plan to include 70 patients that are planned for operation with an uncemented total hip arthroplasty. 35 patients will be randomized to receive the new implant and 35 patients will be included in the control group and receive a standard uncemented prosthesis. All patients will then be followed with CT scans and patient reported outcome measures 3-month, 1 year, 2 years, 5 years and 15 years after the operations. The CT scans will be used both for measurement of migration and wear and development of osteolysis around the implant.

Eligibility Criteria:
Inclusion Criteria:

* Patients are foreseen for implantation of an uncemented acetabular press-fit cup and an uncemented stem
* Age 30-70 years
* Primary osteoarthritis of the hip
* Body Mass Index between 18 and 35 kg/m2
* Willingness and ability to follow clinical investigation protocol

Exclusion Criteria:

* Grossly abnormal hip anatomy (hip dysplasia, Crowe Grade 2 or above, Perthes or other causes)
* Osteoporosis
* Paget's disease
* Inflammatory arthritis
* Secondary osteoarthritis
* Presence of malignancy in the area of surgery
* Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months or less prior to surgery
* Previous surgery in the affected hip
* Inclusion of the contralateral hip in this clinical investigation
* Not suited for the clinical investigation for other reason (surgeon's judgment)
* Pregnant or breastfeeding women
* Prison inmate
Serum Levels of Doxycycline at the Time of Abortion With Two Dosing Regimens

This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D \& E) abortion. The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels, but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion. Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery.

This is a randomized double-blind, controlled trial comparing two regimens of pre-abortion doxycycline. The aims of the study are to determine the serum levels of doxycycline when administered pre-operatively 4 hours or approximately 18 hours before a dilation and evacuation (D \& E) abortion. The hypotheses being tested are that subjects who receive doxycycline with food the night before an abortion will have adequate serum levels, but less nausea and vomiting compared to women who take the doxycycline on an empty stomach on the morning of the abortion. Subjects will either take 200mg doxycycline on the night before and 2 caps placebo with a sip of water on the morning of surgery or 2 caps placebo the night before and 200mg doxycycline on the morning of surgery with a sip of water. All capsules will look identical. Diaries, questionnaires and a 10cc sample of blood for doxycycline levels will be collected from the subjects at the time of surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Gestational age 15-23 weeks by ultrasound.
2. Willing and able to sign an informed consent.
3. Placement of cervical dilators. Dilators must be placed before giving any subject doxycycline in order to ensure that all subjects who receive doxycycline will have an abortion.
4. Willing to comply with the study protocol.
5. Age at enrollment of 18 years or more.

Exclusion Criteria:

1. Need for an urgent D \& E. Indications for this include ruptured membranes, advanced cervical dilation, infection, and fetal demise.
2. Allergy to doxycycline or any tetracycline
3. Exposure to or treatment for gonorrhea or chlamydia within the past 90 days.
4. Current or recent (within the past week) use of any other antibiotic.
5. Prior cardiac valve surgery or cardiac valve replacement. These patients should all receive alternative antibiotics for endocarditis prophylaxis.
6. Active use of alcohol, heroin, or cocaine. Active use of alcohol will be defined as more than 2 drinks per day. Any use of heroin or cocaine will be considered exclusionary.
Response Profiles to High-concentration Capsaicin Desensitization in Patients with Peripheral Neuropathic Pain with or Without Allodynia: a Regional Multicenter Prospective Cohort

Prospective multicenter cohort to determine patient profiles (associated factors, including allodynia) with a better response to pain desensitization by capsaicin delivered in the form of a high concentration patch (8%), in a population of patients with peripheral neuropathic pain and followed up in a pain consultation in the Auvergne Rhône Alpes region.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age on the day of inclusion
* Patient who has been informed and has not expressed opposition to participating in the study,
* Patient with peripheral neuropathic pain (whatever the etiology), defined by :

  * "Neuropathic Pain 4" score ("DN4" score) ≥ 4/10
  * AND pain according to the numerical scale (EN) \> 4/10,
  * AND stable analgesic treatment for at least 1 month,
  * AND with or without mechanical allodynia according to the Quantitative Sensory Testing (QST) : Brush test (dynamic), Von Frey test (static)
  * AND with or without thermal allodynia to hot or cold as determined by a ROLLTEMP-II® (Rolltemp is a device designed for quick screening of temperature sensibility over large body areas).
* Patient responding to an indication of desensitization to high concentration capsaicin concentration and not presenting any contra-indication.
* Patient naïve of high concentration of Capsaicin on the concerned zone
* Patient understanding French

Non-inclusion Criteria:

* Patient with pain related to complex regional pain syndrome (criteria not meeting the indication for capsaicin)
* Patient with active cancer (underlying disease and treatments may modify pain perception),
* Patient receiving or having received in the last 3 months Botulinum toxin A on the concerned area (this treatment of neuropathic pain may modulate the effect of capsaicin and disturb the demonstration of causality),
* Patient with planned surgery within the next 12 months on the painful site (surgery may cause neuropathic damage and/or bias the pain assessment),
* Patient included in an interventional research protocol,
* Patient under guardianship or curators,
* Patient under legal protection

Exclusion Criteria:

None
Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease

Huangkui Capsule is a single medicament of traditional Chinese medicine consists of Abelmoschus manihot and has been widely used to treat kidney disease. The purpose of this study is to evaluate the safety and efficacy of Abelmoschus manihot for treating chronic kidney disease in large scale samples with long time take.

The test has not been completed.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosed as non-ESRD chronic kidney disease (stage I-IV)
* Blood pressure of ≤140/90mmHg
* Obtaining the signed informed consent from patients

Exclusion Criteria:

* Be allergic to Huangkui Capsule
* Combined with severe primary diseases of heart, brain, liver and hematopoietic system and so on, or other serious diseases which can affect the patient's life
* Lactation, pregnancy or plans pregnancy during the study period
* Participating in another clinical study in the same period
HD17 for Intermediate Stage Hodgkin Lymphoma

This study is designed to test the non-inferiority of the experimental arm compared to the standard arm in terms of progression free survival (PFS).


Eligibility Criteria:
Inclusion Criteria:

* Hodgkin Lymphoma
* CS I, II with risk factor (stage IIB with risk factor 1 or 2 are not included)
* large mediastinal mass (\>1/3 of maximum transverse thorax diameter)
* extranodal involvement
* elevated ESR
* 3 or more involved nodal areas
* written informed consent

Exclusion Criteria:

* Leucocytes \<3000/µl
* Platelets \< 100000/µl
* Hodgkin Lymphoma as composite lymphoma
* Activity Index (WHO) \>2