cyrilzakka/clinical-trials huggingface dataset:
Bortezomib-Melphalan Conditioning Regimen vs Melphalan for Frontline Transplant Eligible Patients With Multiple Myeloma

Phase III multicenter randomized, open-label study comparing the efficacy of a combined high dose chemotherapy using melphalan and bortezomib versus melphalan alone followed by stem cell transplant in frontline multiple myeloma patients, non-progressive after induction therapy.


Eligibility Criteria:
Inclusion Criteria:

* Must have results from their initial diagnosis available at the time of screening to confirm all the following :

  1. Diagnosis of multiple myeloma according to the diagnostic
  2. Symptomatic de novo Multiple Myeloma
* Be eligible for high-dose therapy with autologous stem cell transplantation
* Autologous cell graft with a total number of CD 34 cells \> or = 5 X 106/kg before freezing

Exclusion Criteria:

* Progressive disease
* Females participants pregnant or breast-feeding
* A known infection by the human immunodeficiency virus
* An active viral hepatitis B or C
* Unstable angina or myocardial infarction within 4 months prior to inclusion, heart failure NYHA class III or IV angina, uncontrolled, history of severe coronary artery disease, an uncontrolled serious ventricular arrhythmia, a sick sinus syndrome, or electrocardiographic evidence of acute ischemia or conduction disturbances grade 3 unless the patient has a pacemaker
* Uncontrolled hypertension or uncontrolled diabetes within 14 days before enrollment
* A history of another malignancy. If cancer was diagnosed more than 10 years and considered as cured, an authorization may be requested on a case-by-case basis after discussion with the principal investigator
* A significant neuropathy of grade 3-4 or grade 2 with pain in the 14 days prior to enrollment
Cerebrospinal Fluid Cytology-guided Intrathecal Chemo-holiday Therapy for EGFR-positive NSCLC Leptomeningeal Metastases

With the rapid development of targeted drugs, the treatment of patients with leptomeningeal metastasis has become a very difficult problem in clinical work. High-dose targeted drugs and intrathecal chemotherapy are important treatment methods for meningeal metastasis. However, it is vital to note that safety is also of concern in previous studies of intrathecal chemotherapy. In this study, we aim to evaluate the safety and effectiveness of patient using chemo-holiday therapy based on the cerebrospinal fluid cytology, combined with double-dose EGFR-targeted drug in patients with leptomeningeal metastases from EGFR-positive NSCLC.

This is a single arm phase II clinical trial. The objective of the study is patients with leptomeningeal metastases from non-small cell lung cancer after EGFR TKIs treatment. The pemetrexed is administrated by intrathecal injection with a dose of 50mg, once per week for 4 weeks, followed by every four weeks thereafter. The cerebrospinal fluid(CSF) samples are collected every 4 weeks and the cytology examination will be performed. If CSF cytology was negative, CSF cytology was tested again 1 week later. Two negative tests were considered as negative CSF cytology. If the cytology of cerebrospinal fluid was negative after 4 consecutive intrathecal injections, the intrathecal injection should be stopped. If positive, continue to give a intrathecal injection every 4 weeks until CSF cytology is negative. If CSF cytological positivity or worsening of neurological symptoms occurs again during discontinuation, or if new symptoms appear, the intrathecal injection should be resumed every 4 weeks. in the meantime, double dose of vometinib (160mg) is given.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female aged between 18 and 75 years.
2. Histologically or cytologically confirmed diagnosis of NSCLC with EGFR mutations.
3. Cytologically confirmed diagnosis of leptomeningeal metastasis.
4. Normal organ function.
5. No history of severe nervous system disease.
6. No severe dyscrasia.

Exclusion Criteria:

1. Any evidence of nervous system failure, including severe encephalopathy, grade 3 or 4 leukoencephalopathy on imaging, and Glasgow Coma Score less than 11.
2. Any evidence of extensive and lethal progressive systemic diseases without effective treatment.
3. Patients with poor compliance or other reasons that were unsuitable for this study
Study With Two Different Doses of Desmopressin Orally Lyophilisate Tablet With Nocturnal Enuresis

This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed nocturnal enuresis with reduced nighttime urinary osmolality
* Age 6 or above but under 16 regardless of gender
* Out-patient
* Had 10 or more wet nights during the 14-day baseline period and at least 4 wet nights in each respective week
* Deemed healthy by the investigator
* Able to agree to and comply with fluid-intake restriction during the clinical trial and matters specified in the clinical trial protocol
* Consent from the pediatric patient's legally acceptable representative
* Demonstrate an understanding about this clinical trial after receiving an explanation corresponding to the prospective subject's intelligibility
* Show no possibility of being a nursing mother or pregnant, or becoming pregnant
* If under drug or medical therapy other than Desmopressin for treating nocturnal enuresis: able to discontinue such treatment

Exclusion Criteria:

* Suffer from enuresis with an underlying disease
* Participated in another clinical trial within six months preceding consent
* Used an intranasal Desmopressin in the past
* Presently undergoing a systemic antibiotic treatment, a treatment with an antidiuretic or a drug that affects urinary concentration, or a drug or medical therapy for overactive bladder
* Have an anomaly or a disease that may affect the oral absorption of drug products
* Hard to get cooperation from subject by school refusal, punishment or bullying
* Deemed by the investigator to be inappropriate to participate in this trial
* Unable to be placed on water-intake restriction starting from two hours before bedtime
* Evidence of hepatic, renal, cardiac, or pulmonary dysfunction
Individualizing Dose of Growth Hormone to Maintain Normal Growth Velocity After Fulfilled Catch up Growth in Children

The objective was to study whether normal growth velocity can be maintained with adapted GH dosage in GH treated prepubertal children who have responded to GH treatment with fulfilled catch up growth (=difference to target height reached, less than - 0.6 SDS).

The aim of the trial is to study the effect of adapted GH treatment in order to find an individualized GH dose maintaining normal growth velocity close to target height SDS and normal metabolism after fulfilled catch up growth in prepubertal children treated with individual doses of GH within the trial 98-0198-003 (1). The overall aim is to find for the individual the lowest effective GH dose during maintenance period, maintaining normal growth velocity and metabolism, i.e. a satisfactory biological active dose.

Eligibility Criteria:
Inclusion Criteria:

* Participated in the 'GH-dose catch-up study' 98- 0198-003.
* Midparental height reached (difference less than 0.6 SDS)
* Prepubertal at start of the study (girls =B 1, boys: testes :\<; 3ml).
* Signed written informed consent from the patient's parents (and the child if old enough)

Exclusion Criteria:

* Disease affecting growth other than correctly treated hypothyroidism.
* Incapable of following the study protocol (i.e. bad compliance in the previous study).
* Puberty (\> breast stage 2, or testes \> 4ml).
* Poor compliance.
Characteristics of Mediastinal Lymph Node With False Positive FDG PET/CT Results in Lung Cancer Staging : Relation With TB and Latent TB Infection

The purpose of this study is to analyze pathologic and radiologic characteristics of mediastinal lymph nodes with false positive FDG PET/CT results in lung cancer staging and assess relationship between false positive mediastinal lymph node and TB/latent TB.


Eligibility Criteria:
Inclusion Criteria:

* age 20-75, men and women
* person who performed PET/CT and surgical biopsy of mediastinal lymph node for diagnosis of primary lung cancer of metastatic lung cancer

Exclusion Criteria:

* age \< 20
* person who don't agree with enrollment
* illiterate
* person who is diagnosed as active tuberculosis now
* person who has history of hypersensitivity on PPD (tuberculin purified protein derivative)
* pregnant woman
* person who is treated as active tuberculosis
AURORA: Crestor 10mg Versus Placebo in Subjects With End-stage Renal Disease (ESRD)

The purpose of this study is to see if rosuvastatin helps to reduce the number of heart attacks, strokes and cardiovascular deaths in patients undergoing haemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with end-stage renal failure aged 50-80 years, who have received regular haemodialysis treatment for at least 3 months

Exclusion Criteria:

* Subjects will have no underlying condition that is expected to limit survival to less than 1 year and is also unrelated to end-stage renal disease (ESRD). Subjects should not have received a statin therapy within the past 6 months
Functional Power Training on Mobility and Gait Parameters in Cerebral Palsy

Cerebral Palsy is a lifelong neuromuscular disorder impacting movement, posture, and muscle control, ranging from mild hand weakness to severe paralysis. Risk factors are grouped into specific stages: preconception (linked to the mother's health), prenatal (during pregnancy), perinatal (at birth), and the neonatal and infant stages. Functional power training is employed to improve the functional abilities of children with Cerebral Palsy by involving them in various power-based exercises to strengthen muscles, increase power, and build endurance. This study aims to evaluate the impact of functional power training on gait and mobility in children with Cerebral Palsy.

Cerebral Palsy (CP) is a chronic neuromuscular disorder that affects movement, posture, and muscle control, with symptoms ranging from mild weakness to severe paralysis. The risk factors for CP are classified into preconception, prenatal, perinatal, and neonatal categories. Functional power training (FPT) is a therapeutic approach aimed at improving muscle strength, power, and endurance in children with CP. This study seeks to evaluate the impact of FPT on gait parameters and mobility in children with CP. This randomized controlled trial will include 26 children, aged 6 to 12 years, with Gross Motor Function Classification System (GMFCS) I or II. Participants will be randomly assigned to either the experimental group (FPT plus routine physical therapy) or the control group (routine physical therapy alone). Exclusion criteria include recent botulinum toxin A treatment, serial casting within the last 6 months, or selective dorsal rhizotomy. Gait parameters (step length, stride length, cadence, gait speed, and step width) and mobility outcomes (6MWT and Timed Up and Go test) will be assessed before and after the intervention. Data will be analyzed using SPSS version 23.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 to 12
* Gross Motor Function Classification System (GMFCS) I and II
* Either gender will be included

Exclusion Criteria:

* Treatment with botulinum toxin A in lower limb
* Serial Casting of lower limb less than 6 months before the start of the functional power training
* Selective dorsal rhizotomy treatment
* Children who did not (yet) choose walking as their preferred way of mobility
Rectal Indomethacin as Early Treatment for Acute Pancreatitis (INDOMAP Trial)

Acute pancreatitis (AP) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. The production and release of inflammatory factors is generally considered as the key factor of pathogenesis. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly applied agents for inflammatory diseases. A series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ERCP), but high-quality evidence is still lacking in the field of effectiveness of NSAIDs to treat, rather than prevent, other types of AP. Majority of animal experiments showed that NSAIDs had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. Randomized controlled trials are eagerly awaited to elucidate its effects on AP.


Eligibility Criteria:
Inclusion Criteria:

* All patients ages 18-80 years admitted to Peking Union Medical College Hospital (PUMCH) with a diagnosis of AP based on at least 2 of the following criteria:
* Abdominal pain characteristic of AP
* Serum amylase and/or lipase ≥ 3 times the upper limit of normal
* Characteristic findings of AP on abdominal CT scan will be screened for study enrollment.

Exclusion Criteria:

* Onset time \>48 hours
* Presence of renal dysfunction (serum creatinine \> 1.5 \*normal upper limit)
* Active peptic ulcer disease or GI bleeding
* Pregnancy or breast-feeding
* Use of daily antiplatelet or anticoagulant drug(s) within 2 week of presentation
* Hypersensitivity to NSAIDs
* New-onset, exacerbation or uncontrolled hypertension
* Presence of serious cardiovascular events, including severe heart failure, myocardial infarction (MI) and stroke
* Mental disability
Paravertebral Block for Proximal Humeral Fracture Surgery

This study evaluates the effects of T2 paravertebral block block improving interscalene brachial plexus block and superficial cervical plexus block on the relief of pain intensity during elderly proximal humerus fracture fixation surgery. The brachial plexus and cervical plexus block(IC block) will be performed in half of participants, while the T2 paravertebral block combined with IC block will be performed in the other half.


Eligibility Criteria:
Inclusion Criteria:

1. Participant age≥ 65 years
2. Body mass index (BMI) \< 30kg/m2
3. American Society of Anesthesiologists (ASA) classification I-II
4. Anterior operative incision approach

Exclusion Criteria:

1. Request for general anesthesia
2. Nerve block is unable to be performed due to various reasons
3. Coagulation dysfunction or anticoagulation therapy
4. History of upper limb nerve injury or phrenic nerve injury
5. Multiple trauma
6. Uncontrolled respiratory disease (severe chronic obstructive pulmonary disease, asthma, pulmonary infection, pneumothorax, etc.)
7. Uncontrolled hypertension (systolic pressure over 180mmHg or diastolic pressure over 110mmHg)
8. Uncontrolled heart disease (coronary heart disease, valvular disease or arrhythmia, etc.)
9. Stroke or cognitive dysfunction (unable to communicate or cooperate)
10. Hypersensitivity or allergy to anesthetics (ropivacaine or remifentanil)
Biomarker Analyses in Hepatocellular Carcinoma (HCC) Patients Treated With TheraSphere®

To analyze specific angiogenic, inflammatory and immune profiles in hepatocellular carcinoma patients who undergo radioembolization.

Patients who have planned lobar radioembolization (TheraSphere (TS)) and consent to this study will have peripheral blood samples collected pre-TS, post-TS, 4 hours post-TS, 24 hours post-TS, 3 days post-TS, 7 days post-TS and 30 days post-TS to analyze specific angiogenic, inflammatory and immune profiles.

Eligibility Criteria:
Inclusion Criteria:

* Must have the diagnosis of HCC (biopsy or imaging criteria)
* Must have planned lobar TheraSphere treatment
* Must be able to give consent
* Must have an ECOG (Eastern Cooperative Oncology Group) performance status of ≤ 2
* Must have a life expectancy of ≥ 3 months
* Women must not be pregnant with an acceptable contraception in premenopausal women
* Must be \> 4 weeks since prior radiation
* Must be \> 2 weeks since liver surgery
* Must be ≥ 2 weeks post radiosensitizing chemotherapy or \> 6 weeks since prior BCNU (carmustine) or Mitomycin-C

Exclusion Criteria:

* Patients are excluded if they do not meet the inclusion criteria
Endoscopic Ultrasound-guided Large Diameter Lumen-apposing Metal Stent Gastro-gastrostomy for Bypass Reversal in Patients With Roux-en-y Gastric Bypass

The primary objective of this open-label pilot study is to investigate whether an endoscopically placed lumen apposing metal stent is an effective alternative to surgery in patients that have a clear indication for reversal of their gastric bypass.


Eligibility Criteria:
Inclusion Criteria:

* Group 1) patients needing any kind of parenteral nutritional support (eg. hypo- albuminemia, hypovitaminoses, mineral deficiencies,...) that can not be corrected by dietary intervention/oral supplementation
* Group 2) patients with persistent invalidating symptomatic dumping syndrome despite optimal dietary intervention (typical complaints are headache, sweating, trembling, weakness and feeling hungry).
* Group 3) patients with a refractory marginal ulcers with stenosis of the gastrojejunostomy leading to feading difficulties.
* Group 4) patients with F3 or F4 liver fibrosis and a tendency to decompensation after bypass surgery, as demonstrated by an increase in serum bilirubin/INR and/or lowering of serum albumin.

Exclusion Criteria:

1. Uncorrectable coagulopathy
2. Presence of significant portal hypertension as demonstrated by 2.1) the presence of esophageal and/or gastric varices AND/OR 2.2) a hepatic venous pressure gradient (if measured) equal to or more than 10mm Hg AND/OR 2.3) the combination of

   1. a platelet count \<150000/µl AND
   2. liver stiffness measured by elastometry equal to or more than 20 kPa (Baveno guidelines).
3. Pregnant women, breastfeeding women or women that can not assure adequate anticonception for the duration of the study (based on anamnesis).
4. Karnofsky index less than 60
5. Vulnerable patients
Predicting Relapse After Cocaine Inpatient Cessation

Can brain MRI at entry of cocaine inpatient cessation attempt predict relapse during a three month follow-up ? Hypothesis : White matter losses in the prefrontal cortex are associated with relapse to cocaine use.

A multivariate model using MRI parameters, craving score, impulsivity score, and neuropsychological testing results will be tested to predict relapse or continuous abstinence three month after cocaine inpatient cessation attempt.

Eligibility Criteria:
Inclusion Criteria:

* cocaine dependent patient requiring inpatient cessation
* 18 years old and older
* giving his/her consent to come back for visits up to three months
* having a social insurance

Exclusion Criteria:

* minor
* under guardianship
* restraint hospitalization
* contraindication to brain MRI
* pregnant women
Several Studys Showed That Upper Limb Amputated Patients Are Able to Experience the Illusion of the Rubber Hand Whith Prosthesis: We Want to go Futher by Comparing the Strength of the Incorporation According to the Type of Prosthesis Using the Illusion of the Rubber Hand With Prothesis

The goal of this observational study is to compare the strength of the incorporation according to the type of prosthesis (aesthetic, mechanical, myoelectric) with the experience the illusion of the rubber hand. The investigators will replace is the rubber by the patient's prothesis. The population will be people with upper arm amputation above the hand and they will be their own comparation.

Participants will do the the experience the illusion of the rubber hand in asynchronic and synchronic way and to answer questionnaries.


Eligibility Criteria:
Inclusion Criteria:

* At least one upper limb amputation
* Informed and consented to participate to the study

Exclusion Criteria:

* having a history of severe neurological, visual or musculoskeletal impairments (other than the loss of a limb)
* with severe serious psychiatric disorders (e.g. schizophrenia)
* having problems understanding French in order to guarantee a good understanding of the questionnaires
* under guardianship or curatorship
Imaging and Serological Biomarkers of Autonomic Dysfunction After Ischemic Stroke

The goal of this observational study is to

* to investigate the prevalence and time course of autonomic dysfunction in acute ischemic stroke patients;
* to evaluate the influence of lesion location on autonomic dysfunction;
* to identify patterns of structural and functional brain connectivity within the central autonomic control circuits associated with autonomic dysfunction; and
* to explore causal models of the link between brain lesions; cardiac, immunological and endocrine biomarkers; and dysautonomia.

Researchers will compare patients with acute ischemic stroke to patients with transient ischemic attacks to study the effect of acute ischemic brain lesions.

Participants will

* undergo cardiovascular autonomic function testing;
* receive structural and functional MR imaging;
* provide blood samples for determinaton of serological biomarkers auf dysautonomia.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of either

  * acute ischemic stroke with either an ischemic lesion visible on CT/MRI or persistent focal deficits 24 hours after symptom onset, or
  * Transient ischemic attack with transient clinical deficits including motor or speech disturbance and not restricted to isolated vertigo/dizziness, visual disturbance, or sensory disturbance.
* symptom onset within 72h prior to hospital admission,
* a pre-stroke/TIA ability to walk without help from another person (modified Rankin scale score \< 4),
* age \> 18 years, and
* informed consent by either the patient or a legal representative (including a spouse)

Exclusion Criteria:

* In-hospital stroke,
* contraindications to MR imaging (e.g., claustrophobia, pregnancy, pacemakers, implants),
* known moderate to severe dementia,
* previous structural brain damage (except leukoariosis due to cerebral small vessel disease),
* hemodynamically relevant stenosis of the common or internal carotid artery, or
* left heart failure with estimated left ventricular ejection fraction \< 50%,
* concomitant systemic illness that can lead to dysautonomia, such as an active infection, thyroid disease, or neurodegenerative disorder (e.g. PD, MSA).