cyrilzakka/clinical-trials huggingface dataset:
Partners For Life: Off-line Health Promotion Program for Ultra-orthodox Jewish Women During the COVID-19 Pandemic

The purpose of this study is to evaluate a unique culturally-tailored intervention aimed at increasing healthy eating and physical activity in Ultra-Orthodox Jewish women during the COVID-19 pandemic. Utilizing a pre-post study design, this intervention is based on the CDC's Diabetes Prevention Program (DPP) and integrates low-tech media, partner learning, group support, and practical workbook content.

UOJ women in Israel have poorer health outcomes and sub-optimal health behaviors than their counterparts. Contributing factors to these disparities include poverty, limited access to information, and insufficient culturally-appropriate opportunities. COVID-19 has exacerbated this inequity, with reduced income, opportunities and time availability, as well as increased weight, social isolation, loss, stress and emotional issues. While COVID-19 brought these health issues to the forefront, they are ongoing - and currently overlooked.

The purpose of this study is to evaluate a unique culturally-tailored intervention aimed at increasing healthy eating and physical activity in Ultra-Orthodox Jewish women during the COVID-19 pandemic. Utilizing a pre-post study design, this intervention is based on the CDC's Diabetes Prevention Program (DPP) and integrates low-tech media, partner learning, group support, and practical workbook content. Participants are recruited through an Ultra-orthodox Jewish continuing education institution for women and either register with a friend or are assigned a partner. Each woman receives a pedometer and workbook with information and skill-building worksheets to complete weekly in pairs (via phone or in person). All dyads will join weekly phone-based group meetings led by a group leader, to share challenges and successes as well as problem solve. It is hypothesized that this intervention will increase the targeted health behaviors as well as reduce weight in participants.

Eligibility Criteria:
Inclusion Criteria: Females aged 18-85, willingness to commit to participation in the lifestyle intervention and follow-up.

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Exclusion Criteria: Pregnancy, history of schizophrenia, severe depression, untreated bipolar disorder, end-stage renal disease, type 1 diabetes, unstable angina, congestive heart failure, inability to participate in the group without assistance, dementia, inability to communicate in Hebrew.
Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment

The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal degenerative pathologies, or degenerative disc disease (disease that occurs when the spinal disk break down) associated pathologies.

Part of their standard of care, participants will be questioned on their back and leg pains, their disability and if they have encountered any adverse effects since the Spinevision posterior fixation system implant surgery. Those data will be collected up to twenty four (24) months after the Spinevision posterior fixation system implant surgery.

The Fixed D3 study is a multicentric, non-randomized, ambispective, post market clinical follow-up study. This means that either subjects already implanted with one (1) of the Spinevision posterior fixations systems (Lumis, Plus or Ulis) - retrospective subjects - or subjects planned for treatment with one of the Spinevision posterior fixation system (prospective subjects) can be enrolled in the study.

Standard of care data up to twenty four (24) months post Spinevision posterior fixation system implant procedure will be collected; key data include back and leg Visual Analogue Score (VAS) pain, Oswestry Disability Index (ODI) score, and adverse events.

Data will be collected at pre-operative, per-operative, and post-operative Month 2, Month 6, Month 12 and Month 24.

Eligibility Criteria:
Inclusion Criteria:

* Patient implanted with Lumis®, Plus® or Ulis® posterior fixation system
* Patient of 18 years old and more
* Patient has provided signed informed consent or did not oppose to his/her data collection, per local regulation

Exclusion Criteria: contra-indication

* trauma (i.e., fracture or dislocation)
* Known or suspected allergy or intolerance to the implanted material, mainly to metal (e.g., cobalt, chromium, nickel, etc.)
* Any other medical or surgical condition likely to compromise the success of instrumented surgery, such as the presence of a malignant tumor or serious congenital abnormalities, raised erythrocyte sedimentation rate not explained by other diseases, high white blood cell count or a tendency to low white blood cell count
* All cases not described in the indications
* Localized infection of the operative site
* All patients with insufficient tissue cover of the operative site
* Local signs of inflammation
* Fever or leukocytosis
* Pathological obesity
* Pregnancy
* Mental illness
* Rapidly evolving joint diseases, bone absorption, osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication, as this medical condition can limit the expected correction gain and stability of mechanical fixation
* All cases not requiring bone graft or bone fusion
* When pedicular screws are used, absence or malformation of pedicles
* All cases requiring a combination of different metals
* All patients not agreeing to comply with post-operative instructions
Compression Device Safety Study on Edema

To evaluate the safety of the prototype Compression Device in subjects with Oedema


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 and 80, willing and able to provide written informed consent, and able to wear the device and follow the requirements of the protocol
* Subjects who have an ankle to brachial pressure index (ABPI) of at least 0.8.
* Subjects who suffer from chronic oedema (i.e. CEAP classification of C3, C4 or C5 1.)
* Subjects who have Chronic Venous Insufficiency (CVI), which has been present for 6 weeks or longer and who have refluxes \>0.5 sec in one or more major venous segments, superficial or deep or both (CEAP classification: C3-C5 1.; Ep,s; As,d; Pr).

Exclusion Criteria:

* Subjects with a history of skin sensitivity to any of the components of the study product.
* Subjects who have previously been entered into the study before
* Subjects who have a history of Deep Vein Thrombosis (DVT) within the last 6 months
* Subjects who have an active leg ulcer (i.e. CEAP classification of C6 1).
* Subjects with active cardiac disease or significant history of cardiac disease (including history of myocardial infarction, heart failure, valvular disease, arrhythmia and those with a pacemaker or have previously had a pacemaker).
* Subjects who have initiated treatment or changed the dose within the past month of pharmaceutical agents that reduce clotting e.g. aspirin (except low-dose aspirin), anti-platelets, anti-coagulants and coumarin.
* Subjects who are currently taking pharmaceutical agents that can modify the amount of leg oedema (e.g., diuretics, dihydropyridine calcium channel blockers, phlebotonic drugs, or fluctuating doses of systemic steroids) or have taken these agents within the last 10 days.
* Subjects who are pregnant
* Subjects who have worn compression therapy in the last 48 hours
Oral Adherence in Hematological Oncology Agents and Impact on Comorbid Therapy Adherence

The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and multiple chronic conditions (2 or more conditions in addition to cancer) through care coordination between pharmacists working in oncology practices and those working in primary care or community practices (Pharmacists Coordinated care Oncology Model \[PCOM\]).

This is a pilot study in which the investigators will examine the association between outcome measures, but the study design and sample size are insufficient to quantify the impact of OAA initiation or OAA adherence on adherence to chronic medications. This pilot study and data analyses are being done in preparation for a larger, controlled study.


Eligibility Criteria:
Inclusion Criteria:

* Receiving cancer care at Vanderbilt University Medical Center
* Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), chronic myeloid leukemia (CML), or multiple myeloma (MM)
* Initiating an oral anticancer agent, either for the first time or a change from previous oral agent
* Diagnosis of 2 chronic conditions, including at least one of the following: diabetes, hypertension, hyperlipidemia, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, and/or chronic obstructive pulmonary disease
* Patients taking at least two chronic medications, including at least one medication for one of the conditions listed above.
* Willing and able to sign informed consent.

Exclusion Criteria:

* Cannot communicate in English
* Concurrent diagnosis of type 1 diabetes or human immunodeficiency virus
Extended Criteria For Fetal Myelomeningocele Repair

The purpose of this study is to offer pre-natal Myelomeningocele (MMC) repair surgery to pregnant women with one of the former surgery exclusion factors

* A BMI of 35-40 kg/m2
* Diabetes; patients will require good glycemic control
* History a previous preterm birth, as long as it was followed by a full term birth
* Structural abnormality in the fetus; abnormality must be minor, not increasing the risk of prematurity. For example cleft lip and palate, minor ventricular septal defect, pyelectasis.
* Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that is not associated with fetal disease, specifically anti-E \< 1:4 or anti-M. Or alloimmunization with negative fetal red blood cell antigen status determined by amniocentesis.

We will be extending the Management of Myelomeningocele Study (MOMs) criteria by including these factors. Prenatal clinical and outcome information will be collected; safety and efficacy will be evaluated

The purpose of this study is to extend the MOMs requirements for pre-natal MMC repair surgery and evaluate safety and efficacy. This will be accomplished through prenatal and post-operative observation and data collection.

The data collected will be documented and collected from prenatal ultrasounds, operative, and delivery reports. We will share our preliminary data with NAFTNet in order to prompt a multicenter trial; this collaboration will help propagate further research and answer clinical questions regarding this extension in surgery criteria.

Eligibility Criteria:
Inclusion Criteria:

* Any woman with a prenatal diagnoses of myelomeningocele.
* Pre-pregnancy BMI of 35-45 kg/m2.
* Diabetes; patients will require good glycemic control
* History a previous preterm birth, as long as it was followed by a full term birth
* Structural abnormality in the fetus; abnormality must be minor, not increasing the risk of prematurity. For example cleft lip and palate, minor ventricular septal defect, pyelectasis.
* Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that is not associated with fetal disease, specifically anti-E \< 1:4 or anti-M. Or alloimmunization with negative fetal red blood cell antigen status determined by amniocentesis.
* same MOMs Trial inclusion criteria with the exception of the above.

Exclusion Criteria:

* poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)
* presence of significant co-morbidities or complications (such as dyslipidemia, uncontrolled arterial hypertension, impaired renal function, neuropathy, retinopathy, CVD)
* severe diabetes complications or associated medical conditions (such as blindness, endstage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure)
* recent (within preceding 12 months) myocardial infarction, stroke or TIA
* unstable angina pectoris
* same MOMs Trial exclusion criteria (with the exception of extended inclusion criteria)
Energy Metabolism for the Patients With Pulmonary Mycobacterium Avium Complex

We aim to examine energy metabolism in patients with pulmonary MAC and clarify the causes of emaciation. We will also investigate the following: the relation between energy metabolism and degree of pulmonary MAC progression; relations among hospitalization, mortality rate, and time-course of changes in energy metabolism; and factors that affect energy metabolism.

Patients with pulmonary MAC with a lower BMI than healthy individuals also have a significantly poorer prognosis than those of normal weight. Emaciation in such patients is thought to be caused by destruction of lung structure from disease progression and an increased resting metabolic rate caused by the increased load from breathing; however, causes of emaciation and details of energy metabolism in these patients have not been studied.

Elucidating details of energy metabolism and causes of emaciation in patients with pulmonary MAC could provide the basis for improvement in nutritional status and activities of daily living through early nutrition therapy and rehabilitation. We propose to clarify the following:

Energy metabolism in patients with pulmonary MAC, including resting metabolic rate, calorie intake and consumption, and hormonal secretions.

Relation between energy metabolism and degree of pulmonary MAC progression.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with pulmonary MAC.

Exclusion Criteria:

* Subjects with severe cardiovascular disease, diabetes, neurological disease, renal failure, endocrine disease and malignant neoplasm.
NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX as Conversion Therapy of Locally Advanced Pancreatic Cancer

The purpose of the prospective, open, randomized controlled, multicenter, exploratory clinical study is to evaluate efficacy and safety of NALIRIFOX Combined With PD-1 Sequential Radiotherapy Versus NALIRIFOX for Conversion Therapy for Locally Advanced Pancreatic Cancer


Eligibility Criteria:
Inclusion Criteria:

1. Histologically or cytologically confi rmed pancreatic cancer;
2. ECOG performance no more than 1;
3. Radiographically assessed as locally advanced pancreatic cancer according ;
4. No previous anti-tumor therapy;
5. Able and willing to provide a written informed consent.

Exclusion Criteria:

1. Prior anti-tumor therapy of any kind;
2. Known to be symptomatic central nervous system metastasis and/or cancerous meningitis.
3. Patients with autoimmune disease or immune deficiency who are treated with immuno-suppressive drugs;
4. Patients with bleeding tendency;
5. Pregnant or lactating women.
Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas

The purpose of this study is to examine the safety and feasibility of performing hyperpolarized metabolic MRI in the diagnosis of brain tumor. This study will also assess the accuracy of hyperpolarized metabolic MRI to diagnose intermediate to patients with infiltrating gliomas and examine the added utility of metabolic MRI over standard MRI imaging

The FDA is allowing the use of hyperpolarized \[1-13C\] pyruvate (HP 13C-pyruvate) in this study.

Up to 5 patients may take part in this study at the University of Maryland, Baltimore (UMB).


Eligibility Criteria:
Inclusion Criteria:

* • Patients with a new brain lesion interpreted as suspected infiltrating gliomas including but not limited to (diffuse astrocytoma WHO grade 2; oligodendroglioma WHO grade 2 and 3; anaplastic astrocytoma WHO grade 3; astrocytoma WHO grade 4), OR, patients with prior history of infiltrating glioma scheduled for surgery for tumor biopsy or resection.

  * Ages 18-80, including male and female
  * Suitable to undergo contrast-enhanced MRI
  * Negative serum pregnancy test

Exclusion Criteria:

* Inability to undergo MRI scan
* Inability to receive IV contrast secondary to severe reaction or renal insufficiency.
A Phase 3 Study of OPC-262 in Patients With Type 2 Diabetes

The purpose of this study is to investigate the safety of OPC-262 administered orally in combination with another oral antihyperglycemic agent


Eligibility Criteria:
Inclusion Criteria:

* 1) Patients who are capable of giving informed consent
* 2) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner

Exclusion Criteria:

* Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
Omega-3 Fatty Acids (Lovaza) for Second Generation Antipsychotic-Associated Hypertriglyceridemia

This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second-generation) antipsychotic medication. The investigators hypotheses are that patients who receive Lovaza will experience a significant decrease in triglycerides from baseline. Secondary hypotheses include: Patients will experience a significant decrease in total cholesterol, and Lovaza will be well tolerated.

This is an open-label pilot study of omega-3 fatty acids (Lovaza) for hypertriglyceridemia in subjects who have been on an atypical (second generation) antipsychotic medication. Eligible subjects include men and women, ages 18-75, who have been taking an atypical antipsychotic for at least three months prior to enrollment. Atypical antipsychotics include: clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega), asenapine (Saphris), iloperidone (Fanapt), and lurasidone (Latuda). Eligible subjects must also have serum triglycerides \>200 mg/dl or high cholesterol \>250 mg/dl at baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Female or male patients, 18-75 years of age.
2. Serum triglycerides \>200 mg/dl or high cholesterol \>250 mg/dl
3. Current use of an atypical (second-generation) antipsychotic medication - including clozapine (Clozaril), olanzapine (Zyprexa), risperidone (Risperdal), aripiprazole (Abilify), ziprasidone (Geodon), quetiapine (Seroquel), paliperidone (Invega) - for at least three months

Exclusion Criteria:

1. Current use of triglyceride or cholesterol-lowering medication other than a statin
2. Current use of omega-3 fatty acid supplement
3. Intake of fish more than twice per week
4. Currently pregnant, or breastfeeding
5. Known hypersensitivity or allergy to omega-3 fatty acids (or any fish allergies)
6. Current use of anticoagulant medication, except for 1 baby aspirin/day - 81mg (coumadin, heparin, Plavix. etc).
7. Consumption of alcohol greater than two drinks per day or active substance abuse
8. Any medical condition that would make participation in the study unsafe, as determined by investigator
Decurarisation Kinetics of Rocuronium in Cervical Surgery

Recurrent nerve monitoring for thyroid and parathyroid surgery contraindicates the pharmacologically active presence of muscle relaxant agents at the time of dissection. A recent formalized expert guideline (RFE 2018) from the French Society of Anesthesia and Resuscitation, SFAR recommends administering a curare to facilitate tracheal intubation and limit laryngeal trauma . This study aims to determine if the level of neuromuscular recovery is consistent with monitoring the recurrent nerve after the use of rocuronium for intubation.

Primary endpoint: Achievement of quality intraoperative laryngeal recurrent nerve monitoring.

The monitoring of the recurrent nerves, innervating the vocal cords, in thyroid and parathyroid surgery has developed in recent years because of its interest as a parameter to reduce the risk of recurrent paralysis.

Monitoring of the recurrent nerves requires contraction of the laryngeal muscle and therefore contraindicates the pharmacologically active presence of muscle relaxants at the time of dissection. Thus, intubation was performed either without curare or with a depolarizing curare (Succinylcholine) whose short duration of action allowed optimal intubation conditions without intraoperative residual effect.

This practice is being questioned due to :

(i) a recent formalized expert referential (RFE) of the French Society of Anesthesia and Resuscitation, SFAR, which recommends administering a curare to facilitate intubation of the trachea and limit laryngeal trauma (grade 1 +) and (ii) a restriction of the indications of succinylcholine by the French National Agency for the Safety of Medicines and Health Products, ANSM, as an adjuvant of general anaesthesia (induction in rapid sequence and electroconvulsive therapy).

In summary, thyroid surgery requires curarisation for intubation and sufficient intraoperative decurarisation to allow monitoring of the recurrent nerves. We hypothesize that the time between intubation and the actual start of recurrent monitoring is consistent with the time to recovery of laryngeal adductor neuromuscular block after injection of rocuronium at a dosage of 0.5 mg/kg.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects requiring general anesthesia for cephalic surgery (thyroid and parathyroid) with an NIM-type intubation tube.
* Subject informed of the study and not having opposed it

Exclusion Criteria:

* Allergy to any of the products used
* Morbidly obese subjects (BMI\> 35)
* Pregnancy
* Predictive criteria for difficult intubation in pre-anesthetic consultation
* Subjects under tutorship or curatorship
* Subjects not affiliated to social security
Effects of Sensory Stimulation Versus Sensorimotor Therapy on Spasticity, Motor Function and Daily Activities in Stroke

To compare effects of exteroceptive and proprioceptive sensory stimulation versus sensorimotor therapy on spasticity, motor function and activities of daily living in patients with stroke

It will be a randomized clinical trial in which total 42 stroke patients will be recruited through non probability convenience sampling techniques. Data will be collected from Gujranwala Medical College Teaching Hospital and Riphah Rehabilitation Center Lahore. The patients who are fulfilling the inclusion criteria will be randomly assigned to either group A (n=21) which will receive intervention exteroceptive and proprioceptive sensory stimulation or to group B (n=21) which will receive sensorimotor therapy for 50 minutes per session, 03 times a week, for 06 weeks. Baseline treatment will be given to both groups. Conventional therapy will be given for 20 minutes per session, 03 times a week, for 06 weeks. Data collection tools will be Fugl-Meyer Assessment, Modified Barthel Index and Modified Ashworth Scale.

Eligibility Criteria:
Inclusion Criteria:

* The patients with chronic stroke (6 months to 2 years)
* Patient 's muscular activity on Stage 3 or higher according to the Brunnstrom's stages of stroke recovery.
* Patients having Mini Mental State Examination score \> 24

Exclusion Criteria:

* Significant musculoskeletal impairments (e.g., arthritis, joint contractures).
* Any other neurological disorders like multiple sclerosis, Parkinson 's disease.
* History of orthopaedic surgery.
* Unstable medical conditions (e.g., uncontrolled hypertension, cardiovascular disease).
* Severe visual or vestibular impairments.
* Lower limb prosthesis.