cyrilzakka/clinical-trials huggingface dataset:
Survey of Current Management of Orthopaedic Complications in CMT Patients

Charcot-Marie-Tooth (CMT) disease is the most common inherited peripheral neuropathy. Foot deformities are frequent complications in CMT patients and orthopaedic surgery is often required. As yet there are no systematic studies on the management of orthopaedic complications in CMT patients and the current approach varies between centres. This study is a survey with the aim of understanding the current surgical approach to orthopaedic complications in CMT.

The target population includes orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients attending centres participating in the Inherited Neuropathies Consortium (INC).

The study protocol consists of a survey addressed to orthopaedic surgeons. The survey will be completed once and it includes two different scenarios of typical CMT patients (one adult and one child).

The orthopaedic surgeons will be asked which surgical procedures they would apply to each scenario:

* forefoot cavus,
* clawtoes and
* hindfoot varus

No medications or therapeutic agents are a component of this project.

Eligibility Criteria:
Inclusion Criteria:

* Orthopaedic surgeons who perform surgical procedures for foot deformities in CMT patients attending centres participating in the Inherited Neuropatheis Consortium (INC)
* Willing to complete survey

Exclusion Criteria:

* Does not read or speak English
* Inability to provide informed consent
Hormonal Effects on Pain Perception

To investigate if labor pain is affected by mother's hormone levels.

The hormonal effects of pregnancy are well documented. Although differences in pain sensitivity between women and men are partly attributable to social conditioning and to psychosocial factors, many laboratory studies of humans have described sex differences in sensitivity to noxious stimuli, suggesting that biological mechanisms underlie such differences. Some animal studies have suggested that sensitivity to pain decreases during pregnancy because of the progressive activation of endogenous pain inhibitory systems. This effect may be mediated by pregnancy-associated hormones, in particular progesterone.


Eligibility Criteria:
Inclusion Criteria:

* healthy pregnant women at term (\>37GA)

Exclusion Criteria:

* chronic pain
* regular analgesic medication
* severe cardiopulmonary problems
* very difficult intravenous access
* advanced labor
* precipitous delivery
Market Research - Acceptability Study for a New PKU Protein Substitute

The aim of this study is to demonstrate that a new protein substitute is acceptable and well tolerated in children with PKU.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PKU or PKU variant requiring a protein substitute.
* Subjects who were already taking a phenylalanine-free/low phenylalanine protein substitute and were willing to try the study product for 7 days.
* Patients aged 3 years of age to adulthood.
* Written informed consent obtained from participant or parental caregiver (as appropriate).

Exclusion Criteria:

* Presence of serious concurrent illness
* Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study.
* Any patients having taken antibiotics over the previous 2 weeks leading up to the study.
* Patients less than 3 years of age.
Hydromorphone for Perioperative Analgesia in Lung Tumor Ablation Parallel Controlled

This randomized, parallel controlled, single blind trial is designed to evaluate the efficacy and safety of hydromorphone versus morphine for perioperative analgesia in lung tumor ablation.

Although the consensus of relevant guidelines and clinical studies recommend the use of opioids for perioperative analgesia in pulmonary tumor ablation surgery, there is a lack of specific analgesic programs for clinical reference. In view of the advantages of clinical application of hydromorphone and the lack of evidence for its application in perioperative analgesia of pulmonary tumor ablation, this study aims to explore the efficacy and safety of hydromorphone in perioperative analgesia of pulmonary tumor ablation, and provide some reference and suggestions for perioperative analgesia of pulmonary tumor ablation.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily attend and sign the informed consent form in person;
* Patients undergoing selective pulmonary tumor ablation;
* The Eastern Collaborative Oncology Group (ECOG) defines an activity status score of 2 or less;
* The estimated survival time is more than 3 months;
* Age 18-80, both sexes.

Exclusion Criteria:

* Severe coagulation dysfunction that cannot be corrected;
* History of severe cardio-cerebrovascular and respiratory diseases;
* Patients allergic to test drugs or contrast media;
* Patients with opioid addiction;
* Patients with cognitive dysfunction;
* Participated in other clinical investigators within three months;
* Investigators or their family members directly involved in the trial;
* Those who are deemed unfit to participate in the study by the investigator.
Lenalidomide Plus R-CHOP for CNS Relapse Prophylaxis in Diffuse Large B-cell Lymphoma

This is an open-label, multicenter, phase 2 trial to explore the efficacy and safety of the combination of lenalidomide and R-CHOP for preventing the CNS relapse in the high-risk diffuse large B cell lymphoma.


Eligibility Criteria:
Inclusion Criteria:

age 18-72 years histologically confirmed DLBCL High risk for CNS recurrence: CNS-IPI:4-6 or involvement of testicular, kidneys or adrenal glands.

No pregnancy plans during treatment

Exclusion Criteria:

Evidence of CNS involvement, Transformed lymphoma, Primary mediastinal B-cell lymphoma EBV+DLBCL, Secondary malignancy, HIV positive, Creatinine \> 2.0 mg/dl Intending to hematopoietic stem cell transplantation history of severe thrombus Pregnant or lactating women
Use of Virtual Reality for the Assessment of Attentional and Reaction Abilities for Fall Risk Evaluation

Aging is a condition characterized by a general decline in physical and cognitive performance, however its effects on various functions are still controversial. These changes lead to an increased risk of injuries, particularly due to falls. According to the World Health Organization (WHO) report, 28-35% of individuals aged over 65 experience a fall each year, and this percentage increases with age. For this reason, preventing falls among the elderly is undeniably one of the most critical public health issues in today's aging society. Nowadays, it is widely demonstrated that the loss of muscle strength and mass, along with decreased balance, significantly increases the risk of falls. However, with aging, numerous other changes occur that contribute to an increased risk of falls, such as a decline in cognitive function, including attention, reaction capabilities and memory, as well as other factors that worsen the quality of life, such as insufficient sleep or nutrition. According to WHO estimates, by 2030, the number of injuries due to falls will double. Therefore, it is of great importance to understand and analyze the factors contributing to falls among older adults in everyday life. For this reason, the principal aim of this study was to evaluate the correlation between the fall index and the Visual Attention, Reaction Time and visual field using the technologies of Virtual Reality (VR). Since aging brigs changes in different aspect, the secondary objectives aim to study the correlation also with i) sleep quantity and quality parameters, ii) risk of malnutrition, and iii) physical condition, muscle conditions and strength in order to have a comprehensive understanding of the factors that most contribute to the risk of falls. In addition to these objectives, the correlation between acute sleep deprivation and the risk of falls will also be analyzed, in order to understand how inadequate sleep quantity can impact injuries in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, of any ethnicity;
* Age ≥ 60 years;
* Cognitively intact;
* Autonomous ambulation;
* Signed and accepted informed consent to participate in all procedures required for the study.

Exclusion Criteria:

* Body Mass Index \> 40.0;
* History of epileptic episodes;
* Bone fractures in the last 6 months;
* Previous surgical treatments for orthopedic conditions performed in the six months prior to study inclusion;
* Use of medications that affect motor coordination, balance, and bone and muscle metabolism;
* Conditions that, despite autonomous ambulation, influence fall risk (e.g., orthopedic, rheumatologic, or neurological conditions);
* Carriers of pacemakers and mechanical implants.
A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia-Derived HIV-1 Recombinant Envelope Glycoprotein (gp160)

To determine the safety of vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) in human volunteers; to evaluate the immunogenicity of this preparation in human volunteers. Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Healthy, adult volunteers without identifiable high-risk behavior for HIV-1 infection are vaccinated. In phase 1, at each participating unit, four volunteers receive a dose of gp160 (12.5 mcg); two volunteers receive placebo. Volunteers are monitored 1 month before proceeding to the second phase. In phase 2, four volunteers receive gp160 (50 mcg); two volunteers receive placebo. Primary immunization and two booster immunizations at day 30 and day 180 are done in an outpatient setting. Volunteers are closely monitored for the first 2 weeks postimmunization (primary and boosters), and extensively followed for a minimum of 2 years. Volunteers may be offered an additional boost of the same preparation at 18 months. Per 07/28/92 amendment, 18 volunteers will receive 200 mcg gp160 in an unblinded study. Volunteers in phase 2 who received four doses of 50 mcg gp160 receive an additional boost of 200 mcg gp160 at 18-19 months post initial vaccination. Per 05/13/94 amendment, volunteers in phase 2 who received the additional 200 mcg boost receive another 200 mcg boost 18-24 months after the last injection (St. Louis University site only).

Eligibility Criteria:
Inclusion Criteria

Patients must be:

* Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
* Available for 1 year of follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* History of positive PPD (tuberculin test).
* Positive syphilis serology (e.g., VDRL).
* Positive for circulating hepatitis B antigen.

Patients with the following are excluded:

* They or their sexual partners have identifiable high-risk behavior for HIV infection.
* History of immunodeficiency or chronic illness.
* Evidence of depression or under treatment for psychiatric problems during the past year.

Prior Medication:

Excluded:

* Immunosuppressive medications.

Prior Treatment:

Excluded:

* Blood transfusions or cryoprecipitates within the past 6 months.

Risk Behavior: Excluded:

* High-risk behavior for HIV infection.
* History of intravenous drug use.
* More than one sexual partner in the last 6 months.
New Imaging Biomarkers Predictive of MA Progression

The pathophysiology of AD is complex. In addition to amyloid plaques and neurofibrillary degeneration, there is a metabolic alteration of the energy pathways, oxidative phosphorylation and glycolysis, which are involved in brain function. Several authors have shown a series of early metabolic dysregulations via an increase in phosphorylation at the origin of neuronal death.

Ultra-high field imaging (7T MRI) may allow, with its better spatial resolution and advanced imaging techniques, to shed light on the mechanisms of progression of Alzheimer's disease. A Magnetic Resonance Spectroscopy (MRS) examination can be coupled to brain MRI without additional risk for the patient. Multinuclear 1H-31P metabolic imaging is a promising tool that can provide information on the metabolic evolutionary profile of AD. Thus, we propose a longitudinal study in patients with early-stage AD on 7T MRI-MRS.


Eligibility Criteria:
Inclusion Criteria:

* French-speaking patients aged 60 to 90 years,
* Patient in the context of Alzheimer's disease \* for which imaging after MRI is prescribed as part of the usual diagnostic process,

  \*Alzheimer's disease is diagnosed by the doctor of the memory consultation and is defined by :Evidence of a storage disorder in verbal episodic memory at LR/RI defined by a sum of LR \< 17/48 and sum of RT \< 40/48 +/- Impairment of executive functions possible (BREF, TMT grefex, verbal fluencies) +/- Impairment of instrumental functions possible (Grémots noun naming, Rey's figure, Mahieux's Battery).
* MMSE score ≥18,
* Written informed consent after the patient has been informed,
* Progressive decline for at least 6 months.

Exclusion Criteria:

--Partially or completely illiterate patient unable to read and write,

* Patient with an absolute contraindication to 7T MRI
* Severe psychiatric pathology not balanced,
* Non-degenerative neurological disease (stroke, multiple sclerosis ...),
* Patient with tumor or inflammatory pathology, or vascular leukopathy visualized in MRI (Fazekas score \> 3)
Buprenorphine for the Treatment of Neonatal Abstinence Syndrome

Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual (under the tongue) buprenorphine is able to be used safely and easily in newborns with the neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine is associated shorter stays in the hospital and fewer days of treatment than the use of standard therapy. Another secondary goal will be to understand buprenorphine concentration in the blood of babies treated with the drug (this is called "pharmacokinetics").


Eligibility Criteria:
Inclusion Criteria:

* ≥ 37 weeks gestation
* exposure to opiates in utero
* demonstration of signs and symptoms of neonatal abstinence syndrome requiring treatment

Exclusion Criteria:

* major congenital malformations and/or intrauterine growth retardation
* medical illness requiring intensification of medical therapy
* concomitant benzodiazepine or severe alcohol abuse, self-report of regular use of alcohol or of benzodiazepines use in the past 30 days, and/or receipt of benzodiazepines by prescription (as determined by self-report or intake urine) by the mother during pregnancy,
* concomitant use of CYP 3A inhibitors (erythromycin, clarithromycin, ketoconazole, itraconazole, HIV protease inhibitors) or inducers (rifampin, carbamazepine, phenobarbital) prior to initiation of NAS treatment
* seizure activity or other neurologic abnormality
* breast feeding
* inability of mother to give informed consent due to co-morbid psychiatric diagnosis
* hypoglycemia requiring treatment with intravenous glucose
S9811 Hydroxyurea in Treating Patients With Unresectable Benign Meningioma

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

PURPOSE: This phase II trial is studying how well hydroxyurea works in treating patients with unresectable benign meningioma.

OBJECTIVES:

* Determine the partial and complete response rates in patients with unresectable benign meningioma treated with hydroxyurea.
* Assess the quantitative and qualitative toxic effects of this drug in this patient population.

OUTLINE: Patients receive oral hydroxyurea twice daily for 2 years in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 months, 6 months, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study within 13 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed unresectable primary, recurrent, or residual benign meningioma
* Measurable disease by CT scan or MRI
* Must have disease progression within the past 10 years OR progressive neurologic deficit within the past 6 months
* Must have undergone prior radiotherapy with subsequent disease progression OR refused radiotherapy

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* SWOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 4,000/mm\^3
* Platelet count at least lower limit of normal

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior cytotoxic chemotherapy for meningioma
* Prior mifepristone allowed
* No other concurrent chemotherapy

Endocrine therapy:

* Concurrent glucocorticoids and hormone replacement therapy allowed if stable dose maintained for at least 72 hours prior to CT scan or MRI
* No concurrent antitumor hormonal therapy

Radiotherapy:

* See Disease Characteristics
* At least 6 months since prior radiotherapy
* No concurrent radiotherapy

Surgery:

* Not specified
Transverse Colostomy for Refractory Hemorrhagic Chronic Radiation Proctitis: a Prospective Cohort Study

Refractory rectal bleeding of chronic radiation proctitis (CRP) is still problematic and does not respond to medical treatments including reagents, endoscopic argon plasma coagulation (APC) or topical formalin. We proposed this prospective cohort study, to assess the efficacy and safety of colostomy in treating refractory hemorrhagic CRP with moderate to severe anemia, to provide higher-quality evidence of colostomy in these patients.

Chronic radiation proctitis (CRP) is a common complication after radiotherapy of pelvic malignancies, accounting for 5%-20% of cases. Rectal bleeding is the most common symptom, which accounts for \> 80% of CRP patients. Mild to moderate bleeding can be controlled by medical agents like sucralfate, endoscopic argon plasma coagulation (APC) or topical formalin. Severe and refractory bleeding is still problematic and refractory to these above medical treatments. Our previous retrospective study found that colostomy obtained a higher rate of bleeding remission (94% vs 12%) in 6 months, especially in control of transfusion-dependent bleeding (100% vs0%), when compared to conservative treatments.

Eligibility Criteria:
Inclusion Criteria:

* Histologically diagnosed with pelvic malignancies, including gynecologic, prostate, or urinary cancers;
* History of pelvic radiation;
* No tumor recurrence or metastasis;
* Refractory hemorrhagic CRP;
* Time of rectal bleeding \>6 months;
* SOBS=3 points;
* severe anemia （Hb≤7 g/dl）or transfusion history for CRP bleedings.

Exclusion Criteria:

* Severe complications of CRP, including deep ulcer or fistula, stricture, necrosis, refractory perianal pain;
* Other hemorrhagic diseases, like III-IV degree hemorrhoids;
* History of colon or rectum resection;
* Intestinal obstruction and surgery needed;
* with contraindications to general anaesthesia (ASA class 4 or 5);
* pregnant or breast-feeding;
* history of mental disorder.
The Sympara VIBE Study for Hypertension

The purpose of the VIBE study is to evaluate the efficacy and safety of the Sympara Therapeutic System in the treatment of hypertension


Eligibility Criteria:
Inclusion Criteria:

* Office systolic blood pressure of ≥150mmHg based on an average of three (3) blood pressure reading measured at both the initial screening visit and a confirmatory screening visit OR a mean daytime systolic blood pressure ≥135mm Hg on 24-hour Ambulatory Blood Pressure Measurement
* Receiving and adhering to an appropriate anti-hypertensive treatment regimen, as prescribed by physician
* Minimum six- (6) month history of diagnosis and treatment of hypertension

Exclusion Criteria:

* Previous renal denervation or carotid barostimulation implant
* Secondary causes of hypertension or primary pulmonary hypertension
* Prior surgery or radiation to the area of the carotid sinus, or presence of a stent or other implant in the carotid artery
* Known or suspected baroreflex failure or significant orthostatic hypotension
* One or more hospital admissions for a hypertensive crisis within the past year
* History of myocardial infarction, fibrillation event, unstable angina pectoris, syncope, transient ischemic attach (TIA) or a cerebrovascular accident within six (6) months of the screening period, or has widespread atherosclerosis with documented intrasvascular thrombosis or unstable plaques
* Diabetes mellitus (Type 1)
* Chronic renal disease requiring dialysis
* Kidney or liver transplant
Study Of Single Doses Of PF-06291826 (Tafamidis) In Japanese And Western Subjects

The purpose of this study is the following:

* To evaluate the safety, tolerability, and pharmacokinetics (PK) of orally administered tafamidis in Japanese and Western healthy volunteers at single dose.
* To compare Japanese and Western PK profiles.
* Determine the PD stabilization effect of tafamidis on human transthyretin (TTR) in a validated ex vivo assay.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or females.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2.

Exclusion Criteria:

* Pregnant or nursing females.
* Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception.
Analysis of Respiration-induced Deformations in Visceral and Renal Arteries Before and After Stenting During Branched Stent Treatment.

Aneurysm of the abdominal aorta is defined by a loss of parallelism of the arterial wall. The main risk of this pathology is the rupture of the aneurysm which is life threatening and this risk increases with the size of the aneurysm. Connected stents allow the management of complex thoracoabdominal aneurysms in patients at high surgical risk and/or contraindicated for open surgery. These endovascular techniques have demonstrated their safety and efficacy, however, long-term CT follow-up remains essential to detect complications such as endo-leaks and restenosis/thrombosis of visceral and renal stents. The prognostic factors of these complications remain poorly elucidated. The type of stent to be used could be an explanation, however, no stent has been proven to be superior in this application to date. Data from the literature suggest an influence of stents on the aortic geometry and the arterial axes of the digestive tract during respiratory movements. The work of the Stanford vascular surgery team shows that the deformations and modifications of the geometry of these stents induced by the respiratory cycle could have a negative impact by migration, stenosis and thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* no contre indication for coroscanner

Exclusion Criteria:

* pregnant woman
* allergy to iodinated contrast media
* vulnerable people