cyrilzakka/clinical-trials huggingface dataset:
Percutaneous Vertebroplasty Versus Conservative Treatment of Pain

The purpose of this study is to compare the effect of vertebroplasty with that of traditional medical treatment in the treatment of painful vertebral fractures in osteoporotic patients.

In vertebroplasty a bone cement is injected in one or more fractured vertebra. The indication is pain that needs high doses of analgesics.

The cement is a well known product called poly methyl metacrylate (PMMA) normally used fixate joint prosthesis.

Vertebroplasty is done in local anaesthesia. The treatment was introduced in 1984 in France and today thousands of patients have been treated worldwide, but so far no randomized controlled trials have been published.

Eligibility Criteria:
Inclusion Criteria:

* new pain in spine (within 6 months)
* x-ray verified low energy spinal fracture(s)

Exclusion Criteria:

* less than 20% or more than 90% reduction of the vertebral height
* lack of pain at fracture level
* no need for continuous analgesic treatment
* patient no able to communicate
* general anaesthesia contraindicated
* MRI not possible
* coagulopathy (not adjustable)
* spondylitis
* discitis
* spinal metastasis
Problem-Solving Therapy for Cancer Caregivers in Outpatient Palliative Care

This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care.

This study is a randomized clinical trial of a problem-solving therapy intervention for family caregivers of individuals with cancer receiving outpatient palliative care. Study participants will be randomized to receive either a three-session problem-solving therapy intervention in addition to usual care or three sessions of attention-matched control in addition to usual care.

Eligibility Criteria:
Inclusion Criteria for Family Caregivers (FCGs)

* Must be 18 years of age or older
* Must serve as the unpaid family caregiver of a patient with cancer receiving outpatient palliative care from one of the participating clinical sites. As is common in caregiving research, we will define "family caregiver" as anyone substantially involved in a patient's care on an unpaid basis; a legal or biological relationship will not be required
* Must consent to participate

Inclusion Criteria for Non-Family Caregiver Stakeholders

* Must be 18 years of age or older
* Must be employed by or affiliated with the healthcare system housing one of the participating clinical sites.
* Must consent to participate.

Exclusion Criteria for Family Caregivers (FCGs)

* Younger than 18 years of age
* Paid caregiver

Exclusion Criteria for Non-Family Caregiver Stakeholders

* Younger than 18 years of age
* Not employed by or affiliated with the healthcare system housing one of the participating clinical sites.
LAS41005 in Hyperkeratotic Actinic Keratosis

The aim of this study is to evaluate the efficacy and safety of LAS 41005 compared to cryotherapy in subjects with moderate to severe hyperkeratotic actinic keratosis (punch biopsies).


Eligibility Criteria:
Main Inclusion Criteria:

* Signed and dated written informed consent.
* Men and women aged between 18 and 85 years inclusive.
* Have a general good and stable health condition as confirmed by a physical examination and by medical history.
* Have at least 4 but not more than 10 clinically confirmed hyperkeratotic AK target lesions of moderate to severe intensity within the face/forehead or bald scalp
* Skin type I to IV according to Fitzpatrick's .
* Are free of any significant physical abnormalities (e.g., tattoos, dermatoses) in the potential treatment area that may cause difficulty with examination or final evaluation.
* Physical ability to apply the study preparation correctly and to follow the study restrictions and visit.
* Women of childbearing potential are allowed to participate in this study, only if they use a highly effective method of contraception

Main Exclusion Criteria:

* Have received treatment of AK within the treatment area (face / scalp) in the three months preceding this clinical trial.
* Have known hypersensitivity to the ingredients
* Are subjects under immunosuppressive therapy.
* Having coagulation defects which are inherited or acquired
* Have evidence of clinically significant, unstable medical conditions
* Have currently other malignant or benign tumors of the skin within the treatment area
* Subjects who have taken topical or systemic treatments that might interfere with the study end points, within a time window that is not allowed, or who are currently taking phenytoin, methotrexate or sulfonylurea.
* Subjects taking inhibitors of DPD (e.g. Brivudin, Sorivudin)
* Are known to be pregnant or lactating (currently or within the past 3 months).
* Have any dermatological disease in the treatment area or surrounding area that may be exacerbated by treatment
* Are currently or within the past 8 weeks participating in another clinical study.
* Have active chemical dependency or alcoholism as assessed by the investigator.
* Subject is institutionalized because of legal or regulatory order.
Deep Neural Network Stratification for Use Detecting Endometriosis in Women Affected by Chronic Pelvic Pain (EndoCheck)

The goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of Endometriosis - "EndoCheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test

The objective is to confirm the clinical performance (sensitivity and specificity) of EndoCheck when compared to laparoscopic surgical assessment as an "aid in diagnosis" for endometriosis in subjects who present with chronic pelvic pain.

The primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively. Secondary endpoints include examining the performance of the test in patients stratified by pain severity and other clinical factors.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to provide written informed consent.
* Participant is a female aged 14 to 50 years old at time of consent.
* Participant is scheduled to undergo laparotomy or laparoscopy for symptomology consistent with possible endometriosis

Exclusion Criteria:

* Participant is a female in a pre-menarchal state.
* Participant is pregnant.
* Participant has an active malignancy.
* Participant is known to have tested positive for human immunodeficiency virus or hepatitis A, B, or C.
* Participant has an active pelvic infection or other infections contraindicated for surgery.
* Participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug/ device/ procedure was or is planned to be administered.
* Participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation.
* Participant is under 14 years old or over 50 years old
The Heart Rhythm Twins Study

Premature atrial contractions (PACs) and premature ventricular contractions (PVCs) are observed in the majority of individuals monitored for more than a few hours. Although the clinical course of PACs and PVCs is usually benign, it has been described that high PAC or PVC frequency causes various comorbidities and worsens outcomes in different patient groups. For example, PACs can initiate episodes of atrial fibrillation, and PAC count is highly specific in predicting diagnosis of incident atrial fibrillation. Increasing PVC frequencies are an important predictor of incident heart failure.

While conventional wisdom dictates that common environmental exposures determine PAC and PVC frequencies, this has not born out in rigorous studies. Whether PAC and PVC frequencies may have genetic underpinnings remains unknown.

Comparisons between identical twins and fraternal twins can provide estimates of heritability. Fraternal twins are an ideal control because, like identical twins, they share a womb, have the same birthday, and their environment while growing up are as similar as between identical twins. However, while identical twins share approximately 100% of the same inherited DNA, fraternal twins share, on average, about 50%. By monitoring identical and fraternal twins with portable electrocardiograms (ECGs), we will be able to count the PACs and PVCs over a consecutive timespan to describe the familial aggregation of these complexes. This, to our knowledge, would be the first study to compare PAC and PVC frequencies in identical and same-sex fraternal twins, providing the first assessment of how genetical inheritance may influence cardiac ectopy burdens.


Eligibility Criteria:
Inclusion Criteria:

* Identical or same-sex fraternal sets of twins
* English-speaking

Exclusion Criteria:

* Pregnancy
* Current anti-arrhythmic medication use (including beta blockers)
* Diagnosis of congenital heart disease
* Diagnosis of persistent or permanent atrial fibrillation
* Prior cardiac ablation
Efficacy and Safety Study of Bimatoprost 0.01% Alone Compared With Travoprost 0.004% and Timolol 0.5% in Subjects With Glaucoma or Ocular Hypertension

This efficacy and safety study will evaluate LUMIGAN® .01 (bimatoprost 0.01%) alone compared to TRAVATAN Z® (travoprost 0.004%) and TIMOLOL GFS, 0.5% (timolol 0.5% ophthalmic gel forming solution) in patients who require IOP lowering therapy.


Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension or glaucoma that requires treatment with medication
* Have a best corrected visual acuity (BCVA) of 20/100 or better in both eyes

Exclusion Criteria:

* History of LASIK, LASEK, RK, and/or PRK in the study eye(s)
* History of any intraocular surgery or glaucoma laser surgery in the study eye(s) within 3 months
* Use of topical, periorbital, intravitreal or systemic steroid within 3 months or expected use during the course of study
Animal Source Food Supplement and Pregnancy in Vietnam

The purpose of this study is to determine if a nutrient-rich supplement of animal-source foods ingested 5d/wk from pre-conception to term improves maternal nutrient status, decreases infections, and improves birth weight and rates of prematurity compared with supplemental ingestion during pregnancy ( from mid-gestation to term) or routine prenatal care.

It has been known for over 80 years that maternal starvation reduces fetal growth and increases neonatal infections. Many different nutrition programs have been targeted to pregnant women to improve pregnancy outcomes. The impact of these programs has been disappointing, and the prevalence of low birth weight (LBW) and infant mortality remains high, especially in developing countries. More recently, as a result of improved access to cereals following the 'green revolution,' nutritional concerns shifted from protein and energy to micronutrient deficiencies, especially those micronutrients in animal-source foods (ASFs)-iron, zinc, vitamins A and B12. Diets of pregnant women are usually limited to rice and a few vegetables, and they lack key nutrients known to reduce preterm delivery, to support fetal growth, and to prevent infections that leads to early neonatal deaths. Vietnam has a well-established farm system that supports the local production of fish, pork, poultry, and eggs. This provides an opportunity to evaluate the impact of a food-based, micronutrient-rich supplement on pregnancy outcome in high-risk, rural Vietnamese women. Since maternal nutritional status at conception is strongly linked to pregnancy outcomes, we will compare the effect of consuming a micronutrient-rich, animal-source food (ASF) supplement from pre-conception to term with a supplement from mid-gestation to term or routine prenatal care on infant birth weight, prematurity rate, and infant growth during the first 6 months of life. This study will be the first to compare a food-based, micronutrient-rich supplement consumed prior to conception to term with one given only during pregnancy. Although it is recognized by many that pregnancy may be too narrow a window to improve maternal nutritional health, it is typical for micronutrient supplements to only be given from the time of enrolling for prenatal care to term. The results of our study, therefore, will have world-wide implications regarding when maternal supplementation should be given to have the greatest impact on pregnancy outcome.

Eligibility Criteria:
Inclusion Criteria:

* Non-pregnant women registering to marry in the Cam Khe District of Phu Tho Province
* Nulliparous
* Planning to reside in the study site for the next 3 years.

Exclusion Criteria:

* Married
* Have had a previous pregnancy
* Have a history of severe infections (HIV, TB) or metabolic disease (diabetes)
* BMI \<17 kg/m2
* Do not reside in study communes
* Unable to provide informed consent
Clinical Outcome of Implant Removal Versus Retention After Posterior Fixation of Thoracolumbar Fractures

Comparing clinical outcome between patients who underwent metal removal and those who retained the metal


Eligibility Criteria:
Inclusion Criteria:

* age 18-60 years
* Posterior fixation
* Six to nine months after fixation
* Neurologically free patient
* Fracture consolidation detected by ct
* Types A3\&A4 fractures

Exclusion Criteria:

* unstable fractures B\&C
* pathological fractures
* multilevel fractures
* poly trauma patients
EEG Biomarker Study for Participants in the Neurolief "MOOD" Trial

This study will collect EEG data at 3 time points from up to 40 adults who are enrolled in a double clinical trial investigating a device that delivers noninvasive, self-administered external Combined Occipital and Trigeminal Neurostimulation (eCOT-NS) treatment for Major Depressive Disorder (Relivion®DP). Baseline (Pre-treatment) Frontal EEG Alpha Oscillations (Power) will be compared post-stimulation power.

EEG Biomarkers may be useful for understanding abnormal brain oscillations associated with Major Depressive Disorder (MDD) and other psychiatric disorders as well as the brain changes that occur when symptoms remit. This study will invite adults with MDD who enroll and are randomized in the Neurolief Sponsored "MOOD" study to undergo collection of EEG data at pre-treatment baseline, again after completing the 8-week blinded treatment phase, and, if eligible/appropriate, again after completing an 8-week open-label treatment phase. EEG will be recorded at rest and during a computer task. This EEG "add-on" study is observational in nature, as it will not manipulate the treatment assignment in the MOOD clinical trial or otherwise impact concurrently ongoing treatments for any condition. Researchers collecting and analyzing EEG data will be blinded to treatment assignment when participants are in the double-blinded treatment phase of the MOOD clinical trial. EEG data will be processed and analyzed to evaluate changes in frontal alpha oscillations associated with 8 weeks of active Relivion®DP stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Meets all criteria for participation in the Neurolief-sponsored MOOD clinical trial (NCT04279522) and has been randomized to a treatment group for the double-blind phase.
* Is willing and able to participate in up to 3 additional research visits for EEG data collections.

Exclusion Criteria:

* none
Long-term Daily Use of Trazenta® Tablets in Patients With Type 2 Diabetes Mellitus

Study to investigate the safety and efficacy of long-term daily use of Trazenta® Tablets as monotherapy in patients with type 2 diabetes mellitus and to assess baseline characteristics of patients with type 2 diabetes mellitus starting Trazenta® Tablets or any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug).


Eligibility Criteria:
Inclusion criteria:

* Male and female patients with type 2 Diabetes Mellitus who have never been treated with Trazenta tablets / Linagliptin (monotherapy) before enrollment. (Trazenta group)
* Patients with type 2 Diabetes Mellitus starting any other oral antidiabetic monotherapy (naïve or switched from prior therapy of different oral antidiabetic drug (OAD)) except Trazenta tablets. (OAD group)

Exclusion criteria:

None
Randomized Clinical Trial of Three Drug Combinations for Late-Stage Gambiense Human African Trypanosomiasis

The treatment human African trypanosomiasis (HAT) in the meningoencephalitic phase relies on two molecules officially registered: melarsoprol, the most commonly used, has a poor safety profile and is becoming ineffective due to parasite resistance; and eflornithine, with better tolerance but more complicated and expensive to implement in endemic countries. nifurtimox, registered only for Chagas' disease but used off-label since the 1970's in series of cases of HAT, is at present the only other available alternative.

The very limited number of compounds available, the lack of prospects for the development of new products and the emergence of resistance are arguments for the use of therapeutic combinations.

This study evaluates the efficacy and safety of three drug combination therapies: melarsoprol-nifurtimox, melarsoprol-eflornithine and eflornithine-nifurtimox.

Dosages per drug are the same in either arm of the study: IV melarsoprol 1.8 mg/kg/day, daily for 10 days; IV eflornithine 400 mg/kg/day, 6-hourly for 7 days; oral nifurtimox 15 or 20 (children \<15 years) mg/kg/day, 8-hourly for 10 days.

For efficacy assessment, patients are followed-up for 24 months after treatment, with planned clinical and laboratory controls.

The safety assessment includes clinical and hematological adverse events.

Eligibility Criteria:
Inclusion Criteria:

* confirmed second-stage T.b. gambiense infection :

  * Infection diagnosed parasitologically (blood or lymph node fluid) and white blood cells \> 5/mm3 in cerebrospinal fluid (CSF)
  * or Trypanosomes detected in the CSF with any CSF cell count
* and resident in the district
* and written consent of the patient or of one of the parents/guardians for children under 15 years of age.

Exclusion Criteria:

* Trypanosome absent from blood (or lymph node fluid) and from CSF
* Or women pregnant on inclusion
* Or previous history of HAT confirmed treated during the last 24 months
* Or impossibility of regular access to the treatment centre during the 2 years following the end of the treatment
* Or less than 10 kg of body weight
* Or refugee patient
Evaluation of Rumination, Frailty and Tanatophobia in Cancer Patients Over 65 Years of Age

The aim of this study is to evaluate tanatophobia and rumination in individuals over 65 years of age receiving cancer chemotherapy and to determine the related factors.

No studies were found in the literature evaluating the relationship between frailty and lack of social support with tanatophobia and rumination. The aim of this study is to evaluate tanatophobia and rumination in individuals over 65 years of age receiving cancer chemotherapy and to determine the related factors.

Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* Conscious and no communication problems
* Being literate
* Willing to participate in our study voluntarily
* Cancer patient receiving active chemotherapy treatment

Exclusion Criteria:

* Not being willing to participate in the research
* Serious life-threatening condition (critical illness, intensive care unit stay, acute complication)
* Dementia, Alzheimer's, cognitive dysfunction
* Major psychiatric illness
Neoadjuvant Chemotherapy in Advanced Epithelial Ovarian Cancer (EOC): A Phase III Randomized Study

To determine the impact of Neoadjuvant chemotherapy on surgical debulking rate, overall and disease-free survival and quality of life (QOL) in patients with advanced EOC.


Eligibility Criteria:
Inclusion Criteria:

* Age:20 to 65 years
* Epithelial ovarian carcinoma
* Stage IIIc \& IV (pleural effusion only)
* ECOG PS 0-2
* Cytology/biopsy positive patients
* Good compliance
* Previously untreated patients

Exclusion Criteria:

* Any medical contraindication of surgery
* Psychiatric illness
* Cardiac, liver or renal dysfunction
Social Cognition in Patients With Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis, also known as Charcot disease, is a neurodegenerative disease evidenced by gradual paralysis of the muscles involved in voluntary motor function. The clinical hallmark of Amyotrophic Lateral Sclerosis is the combination of upper and lower motor neuron signs and symptoms. The most recent studies suggest that up to 50% of Amyotrophic Lateral Sclerosis patients demonstrate mild to moderate cognitive disturbance. Impaired social cognition, including a deficit in the recognition of facial emotions and the identification of vocal prosody, is recognized as a part of the cognitive phenotype of Amyotrophic Lateral Sclerosis, with crucial implications for patients' and caregivers' training. However, studies remain scarce and the data acquired must be supported. The evolution of these manifestations during the disease is still poorly understood.

In this study the investigators aim to assess the social cognition capacities of patients with Amyotrophic Lateral Sclerosis compared to healthy matched control subjects.


Eligibility Criteria:
Inclusion Criteria:

Patient Amyotrophic Lateral Sclerosis :

* Education of at least 7 years
* Native language: French
* Patients Amyotrophic Lateral Sclerosis
* Signature of informed consent to participate in the study
* Accompanied patient

Control subject :

* People without any pathology
* Education of at least 7 years
* Native language: French
* Signature of informed consent to participate in the study

Exclusion Criteria:

Patient Amyotrophic Lateral Sclerosis and control subject :

* Simultaneous participation in another interventional protocol with experimental treatment
* Inability to perform cognitive study tests
* Pregnant, lactating or parturient women
* Persons deprived of their liberty by administrative or judicial decision
* Persons under psychiatric care under duress
* Persons subject to legal protection measures
* Persons out of state to express their consent
* People not affiliated or not beneficiaries of a social security scheme
* History likely to disturb cognition
Behavioral Management of Phosphorus in Hemodialysis Patients

The purpose of this randomized clinical trial is to evaluate alternative technology-supported behavioral approaches to engaging 42 maintenance hemodialysis (HD) patients with persistent hyperphosphatemia in phosphorus binder adherence and dietary phosphorus restriction. Participants will be randomized to 1 of 3 intervention groups: (1) Education (Edu); (2) Edu + Self-Monitoring (SM); or (3) Edu + SM + Social Cognitive Theory (SCT)-based training program.

Investigators will evaluate the intervention in terms of feasibility and acceptability, behavior change at 12 and 24 weeks (reported phosphorus binder adherence, reported nutrient intakes, normalized protein catabolic rate), and clinical outcomes (serum phosphorus concentrations, symptoms). In addition, the impact of the different behavioral approaches on self-efficacy at 12 and 24 weeks, and the mediating effects of self-efficacy in facilitating behavioral changes and clinical outcomes will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Receiving thrice-weekly hemodialysis treatment for at least 3 months
* 3-month average serum phosphorus concentration \>5.5 mg/dL

Exclusion Criteria:

* Unable to participate meaningfully in the combined Edu + SM + SCT intervention, including:
* Unable to read and/or speak English
* Self-monitoring application is currently available in English only (patients will not be excluded from participation on the basis of race/ethnicity)
* Cognitively-impaired
* Physically-impaired
* Institutionalized or otherwise having limited control over diet
* Life expectancy of \<1 year per dialysis center staff
* Women who are pregnant or become pregnant during the study