cyrilzakka/clinical-trials huggingface dataset:
First Relief Treatment for Peripheral Neuropathy

To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Neuropathy pain

Exclusion Criteria:

* Patient with inbuilt pacemakers or any other devices which allows current into the body, pregnant ladies.
Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients

The study will be designed to compare the analgesic effect of ultrasound-guided pectointercostal fascial plane block versus tansversus thoracic plane block in adult cardiac surgery.

A prospective study will be carried out in Alexandria Main University Hospitals on 60 adult patients planned for elective cardiac surgery, after approval of the Ethical Committee of Faculty of Medicine, Alexandria, and having an informed written consent taken from patients included in the study. Patients will be categorized into two equal groups; group P (n=30)) will receive ultrasound-guided pectointercostal fascial plane block and group T (n=30) will receive ultrasound-guided transversus thoracic plane block.

All patients will receive the ultrasound-guided block after induction of anesthesia and an equal booster dose of the same block before extubation in the ICU. Patients in both groups will also receive an ultrasound-guided bilateral serratus anterior plane block before extubation.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patient.
2. Elective cardiac surgery.

Exclusion Criteria:

1. Refusal to participate.
2. Redo or urgent cardiac surgery.
3. Local infection of the skin at the site of needle puncture.
4. Allergy to bupivacaine.
5. Coagulation disorders.
6. Clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension.
7. when extubation is intentionally planned to be delayed
Effects of Static Apnea at Low Lung Volume on Hypoalgesia, Cardiovascular Function and Respiratory Function

The aim of this randomized controlled study is to explore the hypoalgesic response of a 6 minutes of intermittent static apneas training session at low lung volume in healthy subjects; also, as secondary objectives, to analyze the cardiovascular and respiratory response produced during the intervention


Eligibility Criteria:
Inclusion Criteria:

- Asymptomatic subjects aged between 18 and 64 years.

Exclusion Criteria:

* Cardiovascular, respiratory, metabolic, neurological or osteomuscular signs or pathologies.
* History of epilepsy.
* Pregnant
* Pharmacological treatment.
* Participants who present any type of pain on the day of the measurements or who have frequently suffered pain during the previous 4 weeks.
Prevalence of Central Neuropathic Pain After a Stroke in Patients Attending Post-stroke Consultations in the Île-de-France Region

Post-stroke pain is common, affecting 15-50% of patients and significantly impacting their quality of life, rehabilitation, and functional recovery. There are different types of post-stroke pain, including peripheral pain related to spasticity, shoulder pain, complex regional pain syndrome, and headaches, as well as central pain linked to brain lesions. Central Post-Stroke Pain (CPSP) is diagnosed when the pain has neuropathic characteristics (burning, cold, tightness, compression), possibly accompanied by allodynia, hyperesthesia, and sensory-motor disorders localized to the area affected by the stroke. CPSP disrupts sleep, impairs functional rehabilitation, and can lead to depression, anxiety, substance abuse, and cognitive disorders. The prevalence of CPSP varies, ranging from 1% to 35%, but it is likely underreported due to difficulties in detection caused by cognitive or communication issues, the clinical variability of CPSP, and its coexistence with other types of post-stroke pain.

CPSP often remains resistant to standard neuropathic pain treatments, such as anticonvulsants and antidepressants, which may cause side effects that reduce patients' autonomy and quality of life. Non-pharmacological therapies used in other chronic pain conditions may offer promising alternatives, but have not been widely studied in CPSP. Improved clinical characterization of CPSP patients is essential. Following a 2015 decree by the French Ministry of Health, post-stroke consultations are standardized, providing a good opportunity for systematic pain screening. The study proposes a systematic screening of different types of pain during post-stroke consultations, categorizing patients into three groups: those with CPSP, those with pain from another mechanism, and those without pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged ≥18 years
* Patient attending a post-stroke consultation (3 to 6 months after the stroke)
* Stroke confirmed by imaging (MRI or CT scan)
* Francophone patient
* Patient not opposing participation in the study

Exclusion Criteria:

* Patient with cognitive or communication disorders preventing them from completing the questionnaires (as assessed by the investigator)
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under judicial protection
Effect of Magnesium Supplement in Early Pregnancy After ICSI

Daily supplement of magnesium after biochemical diagnosis of pregnancy in females pregnant after ICSI and through out 1st trimester

a fall of magnesium levels at 2-3 weeks of gestation. This drop of magnesium concentration is larger following IVF as compared to spontaneous pregnancies.

so magnesium supplement start after biochemical diagnosis of pregnancy and throughout the 1st trimester

Eligibility Criteria:
Inclusion Criteria:

* age 25_38 years
* BMI 25_30

  * females pregnant after ICSI after biochemical diagnosis of pregnancy

Exclusion Criteria:

* females with poor ovarian reserve and poor responders

  * abnormality in uterine cavity detected by hysteroscopic evaluation pre ICSI and not treated
  * hydrosalpinx
Nutritional Management of Infants With Chronic Diarrhea

The study objective is to assess the growth of infants fed an experimental formula for the nutritional management of chronic diarrhea.


Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to 12 months of age at enrollment
* Candidates for elemental feeding
* Chronic diarrhea and diagnosis of one of the following conditions: short-bowel syndrome, eosinophilic gastroenteritis, food allergy, inflammatory bowel disease, pancreatic disease, protein maldigestion, HIV-advanced disease or other GI disease requiring an elemental diet or have underlying GI disease without chronic diarrhea if his/her chronic diarrhea is controlled or is in remission by a semi-elemental or elemental formula for no more than 13 weeks
* Parents agree to feed infant with experimental formula for least 50% of total calories during study period

Exclusion Criteria:

* Any non-approved concomitant study
A Multicentre Randomised Controlled Trial Comparing Two Strategies for the Diagnosis of Invasive Aspergillosis in High-risk Haematology Patients

Aspergillus is a fungus found in soil, on farms and on construction sites. In those whose immune system is impaired it causes severe infection. The people who are particularly at high-risk of infection with Aspergillus (which is called Invasive Aspergillosis)are those with acute leukaemia who are having chemotherapy and those post bone marrow transplantation. Currently 15% of those at high-risk develop Invasive Aspergillosis and 60-90% of those with Invasive Aspergillosis die.

The main reason for this high death rate is that our current diagnostic tests are not good at detecting infection or often only detect the infection at advanced stages when treatment is ineffective. Because of the limitations of current diagnostic tests the current practice is to give empiric antifungal therapy (EAFT) early to treat suspected Invasive Aspergillosis. However studies have demonstrated that this therapy has only resulted in a minor reduction in the mortality rates and it also causes significant drug toxicity. It is a suboptimal treatment modality.

New tests have recently been developed to diagnose Invasive Aspergillosis. These tests are for the detection of an Aspergillus protein in blood and for the detection of Aspergillus DNA in blood. Available data suggests that these new tests make an early diagnosis and seem to be able to monitor responses to treatment. However no study has been reported to date which demonstrates that the use of these tests can impact on important patient outcomes. This trial is being performed to determine whether the use of the new diagnostic tests to guide antifungal therapy will help improve treatment of Invasive Aspergillosis, reduce drug toxicity and reduce the death rate in the high-risk patients as compared with the current standard method of diagnosis and treatment with EAFT.


Eligibility Criteria:
Inclusion Criteria:

Patients fulfilling all the following criteria will be eligible for enrolment 1. Aged 18-80 years 2. Undergoing allogeneic haematopoietic stem cell transplantation (HSCT) for any reason OR Undergoing intensive combination chemotherapy for acute myeloid leukaemia (AML) or acute lymphoblastic leukaemia (ALL) 3. Has given written informed consent.

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Exclusion Criteria:

Patients with any of the following will be ineligible for enrolment 1. Other immunocompromised states (e.g. HIV infection, solid organ transplantation, autoimmune conditions treated with immunosuppressants etc.) besides those outlined in the inclusion criteria above 2. Currently enrolled in an antifungal treatment trial (not an antifungal prophylaxis trial) 3. Past history of proven or probable IA (as per standardized definitions) during a previous cycle of chemotherapy 4. Currently have active IA or other active invasive fungal infection 5. Prior enrolment in this study

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3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis

Study design: a randomized, crossover trial. Each patient performed three different airway clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral posture \[ELTGOL\], temporary- positive expiratory pressure \[T-PEP\] with not similar autonomy degree in a randomized order. Each technique were applied in 3 sessions during one week at alternate days (Monday /Wednesday/Friday or Tuesday/Thursday/Saturday). The time spent in each bronchial session was 40 minutes. Seven days were the wash-out time period between the different techniques.


Eligibility Criteria:
Inclusion Criteria:

1. - Non Cystic Fibrosis bronchiectasis diagnosed by High Resolution Computed Tomographic
2. - Mean sputum production ≥ 15 ml /24h
3. - Clinical stability in the last 6 weeks
4. - Not carrying out regular chest physiotherapy
5. - Forced expiratory volume in 1 second ≥ 30% pred. ; Forced Vital Capacity ≥ 45% pred. and peak expiratory flow \>270 L/s

Exclusion Criteria:

1. - Smoker or non-smoker form less than 2 years
2. - Cystic fibrosis
3. - Active tuberculosis or sarcoidosis
Intensive Therapies in Children With Hemiplegia

This is a comparative study where two protocols of intensive therapies will be applied to study the improvements in the functional performance of the affected upper limb of children with hemiparesis and check whether to increase their quality of life.

the intervention protocols combine different doses of intensive therapy, being 80 hours of modified constraint induced movement therapy followed by 20 hours for protocol 1 and protocol 2 would be the application of protocol 1 inverted, with this, the investigators want to compare how both protocols interfere in the function of the affected upper limb of children with different levels of bimanual functional performance.

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with Unilateral Infantile Cerebral Palsy, Congenital Infantile Hemiparesis.
* Ages between 5 to 10 years.
* Levels of I-III within the , manual ability classification system, MACS.
* Levels of I-III within the gross motor function classification system, GMFCS

Exclusion Criteria:

- Diseases not associated with infantile hemiparesis.

* Low cognitive level to understand the execution of activities.
* Surgeries of the upper extremity during the 6 months prior to the intervention.
* Structured contractures in the affected upper extremity that cause functional impotence.
* Botulinum toxin two months prior to the intervention and application of it during the treatment.
* Epilepsy not controlled pharmacologically
Carvedilol for Prevention of Esophageal Varices Progression

Carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear.

It has been concluded 40%-70% of chronic hepatitis B patients can achieve fibrosis/ cirrhosis reversion after effective anti-viral therapy. But there is still some patients progress to decompensation. Esophageal varices are the main complication of cirrhotic patients. Propranolol are widely used to prevent variceal bleeding in patients with large esophageal varices. It has been shown the efficacy of propranolol in the preventing of the progression from small to large varices reported no effect. Recently, carvedilol has been shown to be more potent in decreasing portal hypertension to propranolol. But the efficacy of carvedilol to delay the growth of esophageal varices in chronic hepatitis B patients was unclear. The purpose of this study is to demonstrate the efficacy of carvedilol in the preventing of the progression from small to large varices in hepatitis B patients.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female;
* HBV-related liver cirrhotic patients with at least two years of antiviral therapy;
* The presence of small or medium esophageal varices without red color sign;
* HBV-DNA\<1×10E3 IU/ml
* Signature of informed consent

Exclusion Criteria:

* Previous presence of decompensated cirrhosis including ascites, bleeding and HE (hepatic encephalopathy);
* Any contra-indications to beta-blockers including asthma, chronic obstructive pulmonary disease, allergic rhinitis, NYHA (New York Heart Association) class IV heart failure, atrioventricular block, sinus bradycardia (HR \< 50 bpm), cardiogenic shock, hypotension (SBP \< 90 mmHg), sick sinus syndrome, insulin dependent diabetes, peripheral vascular disease.
* Allergic to Carvedilol;
* Any malignancy that affects survival；
* Renal dysfunction；
* History of beta-blockers within last 3 months；
* History of surgery for portal hypertension；History of prior EVL (endoscopic variceal ligation) or sclerotherapy, history of surgery for portal hypertension including portosystemic shunts, disconnection and spleen resection and transjugular intrahepatic portosystemic shunt；
* Severe systemic diseases；
* Refusal to participate in the study.
Foley vs Propess for Induction of Labor in Women With Term PROM : Mode of Delivery, Maternal and Fetal Outcomes

Premature rupture of membranes at term is a rupture that occurs at term (\>37SA) before the start of labor. It complicates 5 to 10% of pregnancies and 6 to 22% of term pregnancies.

Althought some studies support efficacy of the Foley catheter for cervical ripening at term in induction of labor with intact membranes, it has not been well studied in women with premature rupture of membranes at term.

The aim of this retrospective study at the Montpellier University Hospital is to evaluate the effect of the Foley catheter compared to Propess in women with premature rupture of membranes at term, on the induction of labor and the maternal and fetal complications.


Eligibility Criteria:
Inclusion criteria:

* Singleton Pregnancy \>37 weeks of gestation
* Premature Rupture Of Membranes
* Cephalic presentation
* Unfavorable cervix (BISHOP \<7)
* No contraindication of induction methods

Exclusion criteria:

* Multiple gestation
* PROM with spontaneous labor
* Induction of labor with both methods
* Previous cesarean section
* Unexplained metrorrhagia / Placenta praaevia
* Suspected intraamniotic infection
* Herpes simplex virus
* Human immunodeficiency virus
* Any contraindication to vaginal delivery
* Latex allergy
A Study in Healthy Volunteers to Assess the Tolerability and Blood Levels of a Single Dose of AZD7687

This is a Phase I, first time in human, randomised, blinded, placebo-controlled, single ascending dose study in healthy male volunteers conducted at a single centre. The effect of food on the pharmacokinetics of AZD7687 will also be studied.

The study will consist of two parts, a dose escalation part and a food interaction part. The two parts will be run in parallel. In total, 64 healthy volunteers divided in 8 different panels (8 volunteers per cohort) will be exposed to single doses during the dose escalation. Each subject will receive dose only once, except for the volunteers included in the dose steps repeated for food interaction.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* BMI between 19-30

Exclusion Criteria:

* No blood donation prior 30 days
* No other clinical study prior 3 months
Exercise and Severe Depression: Clinical and Biological Analysis

The study aimed to evaluate the use of exercise as a complementary strategy to treat severe major depression in inpatients.

Hypothesis: Exercise can be used as a safe and efficacious complimentary strategy in severe depressed inpatients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Major Depressive Disorder according to M.I.N.I (DSM-IV) criteria American Psychiatry Association(1994)
* score of 25 or more on Hamilton-17
* not being involved in other physical activity programs during the hospitalization
* aged between 18 and 60 years
* being able to read, understand, and provide written informed consent

Exclusion Criteria:

* have three or more cardiovascular risk factors according to Physical Activity Readiness Questionnaire (PAR-Q)
* are unable to exercise due other clinical condition
* have diagnosis of Schizophrenia, Bipolar disorder or current use of alcohol or other drugs according to M.I.N.I DSM-IV criteria American Psychiatry Association(1994)
* if they are taking beta-blocking medications
Study of TV-1106 in Growth Hormone-Deficient Adults

The primary objective of this study is to determine the efficacy of 6 months of treatment with TV-1106 compared with placebo on body fat composition.


Eligibility Criteria:
Inclusion:

* males and females 18 years of age or over
* diagnosis of adult growth hormone deficiency (GHD) for at least 6 months, or patients who have hypopituitarism from surgical resection
* no history of exposure to any rhGH within the past 12 months prior to screening
* stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening

  * Other criteria apply, please contact the investigator for more information

Exclusion:

* patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator
* Presence of contraindications to rhGH treatment
* patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening
* patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix)
* patients with a previously treated pituitary tumor with evidence of tumor progression in the past year patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening
* presence of Prader-Willi syndrome, Turner's syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active Cushing's syndrome in the past 1 year
* patients with type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HBA1c) of ≥8%
* patients using weight reducing agents or appetite suppressants
* women who are pregnant or nursing, or planning pregnancy during the study period

  * Other criteria apply, please contact the investigator for more information
Osimertinib Combined With Bevacizumab in Patients With Brain Metastasis Epidermal Growth Factor Receptor (EGFR) Mutation Positive Metastatic Non-Small Cell Lung Cancer

There is no positive data on osimertinib in the treatment of metastatic EGFR mutation positive non-small-cell lung cancer (NSCLC). The purpose of this study is to study osimertinib combined with bevacizumab in the management of patients with brain metastasis harboring EGFR mutation.

Lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent \[%\] of cancer deaths); NSCLC accounts for 80% to 85% of lung cancers. The hypothesis is that osimertinib combined bevacizumab in patients with advanced NSCLC patients with brain metastasis characterized by EGFR mutations . Efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. Safety assessments will include physical examinations, vital signs, electrocardiograms (ECGs), Eastern Cooperative Oncology Group (ECOG) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis).

Eligibility Criteria:
Inclusion Criteria:

Participant must have histologically or cytologically confirmed, metastatic, nonsquamous non-small cell lung cancer (NSCLC) Partipiant harboring primary epidermal growth factor receptor (EGFR) Exon 18-21 mutation and brain metastasis.

Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1, or 2.

Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.

A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.

Exclusion Criteria:

Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.

Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis.

Participant has a contraindication to the use Osimertinib or Bevacizumab.
A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.

This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18-65 years of age;
* type 2 diabetic patients;
* naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for \>=2 weeks before first treatment.

Exclusion Criteria:

* type 1 diabetes mellitus;
* clinically significant cardiovascular disease.