cyrilzakka/clinical-trials huggingface dataset:
Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea

Significant gains have been made in reducing the overall burden of malaria worldwide, however these have been far greater for Plasmodium falciparum than P. vivax.

P. vivax remains a major obstacle to malaria control and elimination efforts, largely due to its ability to form dormant liver stages (hypnozoites) that allows it to escape detection and treatment. Importantly, they are susceptible only to 8 aminoquinolines such as primaquine. However, primaquine is associated with risk of haemolysis in individuals with a genetic condition, called glucose-6-phosphate dehydrogenase (G6PD) deficiency. Additionally, the recommended 14-day prolonged treatment regimen is associated with poor treatment adherence, hence ineffective primaquine treatment. Innovative solutions to the radical cure of both the blood and liver stages of P. vivax are urgently required.

The PNG National Department of Health has requested a pragmatic study of the feasibility and cost-effectiveness of implementing point-of-care G6PD testing followed by high-dose, short-course primaquine treatment regimens for patients with P. vivax malaria. This revised case management is to be combined with practicable enhancements to patient education, supervision, malariometric surveillance and pharmacovigilance.

This will be a before-after longitudinal health facility-based study implemented at Napapar and Mugil health centres and Baro and Wirui clinics. A staged approach for the implementation of the revised case management strategy will be used, including patient education and counselling, community-based clinical review, with mixed methods evaluation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with vivax malaria

Exclusion Criteria:

* Patients who are pregnant
* Patients who are breastfeeding
* Patients with a Hb \<8g/dL
* Patients with a previous adverse reaction to primaquine
* Patient with severe malaria
Approach to Sexuality From Occupational Therapy in People With Acquired Brain Injury in Subacute Stage

Objectives: To analyse if people with acquired brain injury in sub-acute situation, as well as their relatives, and/or partners, consider relevant the approach to sexuality during their Occupational Therapy intervention.

Methodology: This study presents a qualitative design with a phenomenological approach. Twelve participants were interviewed: eight people with acquired brain injury, two relatives and two partners who agreed to participate. The information has been collected through interviews.


Eligibility Criteria:
People with Acquired Brain Injury

Inclusion Criteria:

* Being over 18 years.
* Have a diagnosis framed within the concept of Acquired Brain Injury.
* To be in the sub-acute stage after the Acquired Brain Injury.
* Take Occupational Therapy to the Neurology Service of the Rehabilitation Unit of the Maritime Hospital of Oza (CHUAC) for a minimum of two months.

Exclusion Criteria:

* Do not accept to participate in the study.
* Present a decrease in the level of consciousness.
* Present alterations at the cognitive level that suppose a score of less than 20 on the Mini-mental State Examination (MMSE).
* Present disinhibition after acquired brain damage.
* Present sensory aphasia.

Partners and relatives of people with Acquired Brain Injury

Inclusion Criteria:

* Being over 18 years.
* Being partner or relative of a person who has a diagnosis framed within the concept of Acquired Brain Injury.
* Being partner or relative of a person who is in the sub-acute stage after the Acquired Brain Injury.
* Being partner or relative of a person who takes Occupational Therapy to the Neurology Service of the Rehabilitation Unit of the Maritime Hospital of Oza (CHUAC) for a minimum of two months.

Exclusion Criteria:

* Do not accept to participate in the study.
* Present a decrease in the level of consciousness.
* Present alterations at the cognitive level that suppose a score of less than 20 on the Mini-mental State Examination (MMSE).
Study of the Absorption of Vitamin E Water-soluble Form (Pegylated) in the Familial Hypocholesterolemia With Chylomicron Retention

To evaluate the kinetics of intestinal absorption of vitamin E water-soluble form from the classical lipid-soluble form in a population of patients with intestinal malabsorption (hypocholesterolemias family by retention of chylomicrons).


Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from familial hypocholesterolemia by retention of chylomicrons
* Systematically followed in the department of Gastroenterology and Paediatric Nutrition in Women Mother Child's Hospital or in the endocrinology department of GHE (Louis Pradel Hospital);
* During treatment with oral vitamin E;
* over the age of 3 years and weighing over 16 kg at the time of inclusion
* For which there is a signed informed consent from the patient or parents / guardians in the case of a minor patient, and benefit from social security coverage.

Exclusion Criteria:

* Patient with encephalopathy
* Hypersensitivity to the active substance or the excipients of Vedrop
* A suspected allergy to local anaesthetics (including xylocaine)
* Patients who may not be compliant to treatment (psychiatric);
* In case of refusal to participate in the study from the patient and / or parents or legal guardian;
* Patients unable to consent (if patients with encephalopathy)
Outcomes of Autologous Bone Marrow-derived Mononuclear Cell Transplantation in the Management of Neurological Sequelae

The purpose of this study is to evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in the management of neurological sequelae after traumatic brain injury

To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell transplantation in 25 patients with neurological sequelae after traumatic brain injury compared with 25 patients in control group (no intervention) at the time points of baseline, 3rd month (D90), 6th month (D180), and 12th month (D360).

Eligibility Criteria:
Inclusion Criteria:

* Age: from 20 to 50 years
* Gender: either sex
* Duration after Brain trauma: 6 - 12 months
* Functional Independence Measure - FIM \< 69
* Closed head injury

Exclusion Criteria:

* Neurologic impairment or neurological disease before the time of the accident.
* Active infections
* Tumours or failure of heart, lung, liver or kidney, respiratory distress syndrome
* Anaemia, clotting disorder
* Cancer
* Pregnancy
* Alcoholic
* Patient was unemployed or did not attend school before the accident.
* Severe injuries: spinal cord injury, pelvic inflammation, cardiopulmonary
Comparison of Lateralized RTSA With and Without Subscapularis Repair

The purpose of this double-blind randomized controlled trial is to compare patient-reported, clinical, and functional outcomes in patients undergoing RTSA with and without subscapularis repair after placement of a modern "lateralized" implant over the course of 24-months postoperative.

The main objective of this study is to compare patient-reported outcome measures (PROMs), and clinical and functional outcomes between RTSA with and without subscapularis repair. The specific aims for this study are:

Specific Aim 1:

To determine if there is a difference in PROM scores between RTSA with and without subscapularis repair during the 24-month postoperative period.

Specific Aim 2:

To determine if there is a difference between the two surgical approaches with respect to shoulder function, specifically range of motion and strength, during the 24-month postoperative period.

Specific Aim 3:

To determine if there is a difference in shoulder dislocation rates between RTSA with and without subscapularis repair during the 24-month postoperative period.

Specific Aim 4:

To determine if there is a difference in surgical complications, re-operation or revision rates between RTSA with and without subscapularis repair during the 24-month postoperative period.

Specific Aim 5:

To quantify the operative times for RTSA with and without subscapularis repair, and determine if there is a difference between the two approaches.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of glenohumeral arthritis, rotator cuff arthropathy, or massive irreparable rotator cuff tear with surgeon-patient decision to undergo RTSA
* First RTSA implantation
* Absence of neoplastic diseases at the treated site
* Fatty infiltration of the subscapularis is low-grade (i.e. Goutallier \< Grade 3) based on pre-operative CT performed as standard of care in the patient group

Exclusion Criteria:

* Previous shoulder arthroplasty (hemi-, total shoulder, or RTSA)
* Avascular necrosis
* Post-infectious arthritis
* Proximal humerus fracture
* Inflammatory arthritis
* Inability to communicate in English
* Unable to return for study visits to 24-months post-operative (e.g. unable to arrange transportation to study appointments, plans to relocate, etc.)

Intra-operative Exclusions:

* Subscapularis with fatty infiltration (Goutallier ≥ 3)
* Subscapularis that is deemed to be irreparable. An irreparable tendon is defined as one that is not of sufficient quality or does not allow adequate excursion to reach the repair site
* Any anatomical or patient characteristic that warrants a non-lateralized implant
Ligament Tension Measurement in Knee Arthroplasty

1. To develop a new type of knee joint pressure detection device and demonstrate its feasibility
2. To analyze individual differences of knee ligament tension using the new device and explore the influencing factors of ligament tension
3. To explore the correlation between knee ligament tension and postoperative knee function


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving primary knee arthroplasty

Exclusion Criteria:

* Patients having had a surgery history of the ipsilateral knee
An Intraoperative Guidance Platform for Radio Frequency Ablation

This study tests the hypothesis that use of the research RFA (Radiofrequency ablation) Physics Library will result in more frequent technical success (complete necrotization of target tissues) compared to ablations conducted without computer guidance.

The RFA Physics Library -- a Planning and Guidance Platform (PGP) (NE Scientific, LLC) -- will be used to support percutaneous liver RFA under CT-guidance by assisting physicians in the identification of ablation targets, assessment of proper ablation probe placement, and projection of the created ablation zones on the CT image.

Patients referred for curative ablation of an HCC by consensus recommendation of the multidisciplinary Liver Tumor Clinic at a 400-bed academic cancer center from June 2018 through December 2021 were considered for participation in the study.

Inclusion criteria :

patient : over 18 years old , ble to provide informed consent, expected survival \>1 year lesion: HCC, \>2 cm in diameter, located \> 1 cm from any other lesion. procedure : completed using the support of the Accublate simulation software.

Software detail at : Hoffer EK, Borsic A, Patel SD. Validation of Software for Patient-Specific Real-Time Simulation of Hepatic Radiofrequency Ablation. Acad Radiol. 2022 Oct;29(10):e219-e227. doi: 10.1016/j.acra.2021.12.018. PMID: 35039220; PMCID: PMC9276838

Treatment: CT-guided RFA with Boston Scientific LeVeen system, RF3000 Generator. .

Prophylactic antibiotic General anesthesia; imaging during suspended ventilation, no PEEP Ablation per manufacturer's protocol. Target : tumor + 5 mm margin Planning, targeting, intraprocedural repositioning, assessment of ablation coverage using software simulation in conjunction with manufacturer's data map.

Tract ablation

Follow-up clinic visit with contrast-enhanced cross-sectional imaging (MRI or CT) at 3 months, then every 3 months x 2 years. Data review for complications, progression of liver disease, evidence of local, regional, or metastatic disease, and additional interventions.

Outcome measures: primary : local tumor progression secondary: hepatic tumor progression

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Presence of hepatocellular carcinoma with a size equal or larger than 2cm.
3. Scheduled for CT-guided thermal ablation under General Anesthesia
4. Able to provide written, informed consent

Exclusion Criteria:

1. Absolute of relative contraindication to MRI:

   1. the presence of an electronic implant, such as a pacemaker not approved for MRI
   2. the presence of a metal implant, such as an aneurysm clip not approved for MRI
   3. claustrophobia
   4. the presence of other contraindication(s), such as inability to comfortably lie flat, history of working with metal, other implanted hardware or shrapnel
2. Target tumor adjacent to or within prior ablated or resected site.
3. Serious psychiatric illness not adequately controlled to permit patient cooperation to obtain an MRI
A Study of Pemetrexed and Cyclophosphamide Given Every 21 Days in Advanced Breast Cancer Patients

This is the phase 2 portion of a phase 1/2 trial, testing the use of pemetrexed and cyclophosphamide in combination for the treatment of advanced breast cancer. A single arm Phase 1 dose finding (establish maximum tolerated dose) study precedes the randomized phase 2 portion.


Eligibility Criteria:
Inclusion Criteria: - You must be female and at least 18 years old. - You must have been diagnosed with breast cancer. - Your pre-study lab tests are within study requirements. - You must be willing to take folic acid and vitamin B12. Exclusion Criteria: - You are pregnant or breastfeeding. - You have another illness that your doctor thinks would make you unable to participate. - You are currently taking aspirin or aspirin-like medicine and are unable to stop for a few days during each cycle of therapy.
A Randomized Controlled Clinical Trial on the Use of Saline Nasal Irrigations to Eradicate Localized Nasal Infection by SARS-CoV-2

Consecutive adult (\>18 years old) subjects who tested positive for SARS-CoV-2 with nasopharyngeal swab at the local COVID-19 Prevention Centre were included.

Patients were divided into two groups: cases (who performed nasal lavages) and controls (who did not perform lavages), with similar confounding factors (age, comorbidities, vaccination status).

At the moment of diagnosis, patients were asked to fill out an ad hoc questionnaire to evaluate their symptoms at the moment of diagnosis and of negativization.

Subjects were asked to perform, at a daily time of their choice, a nasal swab provided at the moment of enrolment. When the subjects tested negative for the first time, they had to complete the questionnaire once again.

The study was divided into two phases. In the first phase cases were recruited and were given nasal washes (Tonimer Panthexyl®) to be performed three times a day, and in any case after nasal swab. In the second phase controls were recruited and were asked to perform only daily nasal swabs.

Symptoms course and time of negativization were analyzed. Statistic comparisons were made using Kaplan-Meier test. P values \<0,05 were considered to be statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* starting participation to the study within the first 48 hours since diagnosis
* ability in self-swabbing
* ability in self-administration of nasal lavages

Exclusion Criteria:

* age \<18 years
* refusal of participation
* starting participation to the study after the first 48 hours since diagnosis
* no ability in self-swabbing
* no ability in self-administration of nasal lavages
Lifestyle Management for Women With CHD and NIDDM

To develop and evaluate a comprehensive lifestyle self-management (CLSM) program (low-fat vegetarian diet, smoking cessation and stress management training) for postmenopausal women with coronary heart disease and Type II (non-insulin dependent) diabetes.

BACKGROUND:

Coronary heart disease is the leading cause of death among postmenopausal women. Yet few studies have examined the potential for altering risk factors for coronary heart diseases among postmenopausal women, especially as a result of comprehensive lifestyle changes. A pressing need existed for controlled studies to evaluate the effects of comprehensive lifestyle changes on risks for coronary heart disease among postmenopausal women.

DESIGN NARRATIVE:

The comprehensive lifestyle management program appeared to produce substantial cardiovascular benefits among men but little was known about the behavioral processes through which change occurred. Its generalizability and applicability -- especially for high-risk women --was uncertain. The program was compared to a usual care condition in an initial randomized trial. Outcome measures included patient self-care behaviors and health outcomes (serum lipid profiles, blood pressure, relative weight, and glycemic control). Process measures included self-efficacy, personal health models, perceived stress, social support and problem-solving skills. Subjects participated in the intervention for three years, with gradual fading of the program in the third year to evaluate the long-term effects of the program. Analyses included assessments of between groups differences on physiological risk factors, behavioral (lifestyle) measures and process measures as well as maintenance over time. Based upon the results of this study, the long-term goal was to design a second outcome study in which the revised intervention would be evaluated with a larger sample to determine the relative contribution of adding moderate exercise and the effects on reversal of coronary heart disease.

Eligibility Criteria:
No eligibility criteria
rTMS for MDD: 5.5cm Rule vs. F3 Targeting

The purpose of this study is to examine the effects of different treatment locations using repetitive transcranial magnetic stimulation (rTMS) to treat major depressive disorder.

Currently there is little standardization between rTMS treatment programs as to what is the best way to localize the left dorsolateral prefrontal cortex, which is the FDA-approved treatment location for clinical rTMS for major depressive disorder (MDD). Different targeting methods yield locations that can vary by up to a few centimeters. By comparing different treatment locations and obtaining neurobehavioral, neuroimaging, cognitive, and neuropsychological measures, this study would provide the opportunity to identify the optimal treatment targeting method when using rTMS for major depressive disorder in a clinical setting. This study will specifically be focusing on comparing the two most common targeting methods: a target 5.5cm anterior to the motor strip on the left prefrontal scalp and the F3 target location on the left prefrontal scalp as identified using the 10-20 EEG system nomenclature.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of major depressive disorder
* Age between 18 and 90 years
* rTMS is clinically indicated as determined by clinical rTMS physician team at University of Iowa

Exclusion Criteria:

* rTMS contraindication such as implanted ferromagnetic material in the head or history of epilepsy with poorly controlled seizures
* MRI exclusion criteria (if participating in MRI portion of study) including implanted device such as:
* Pacemaker
* Coronary Stent
* Defibrillator
* Neurostimulation
* Or any of the following conditions:
* Claustrophobia
* Uncontrolled high blood pressure
* Poorly controlled atrial fibrillation
* Significant heart disease
* Hemodynamic instability
* Severe kidney disease
* Pregnant, trying to become pregnant, or breast feeding
The Hastiin Bidziil (Strong Man) Intervention

The Hastiin Bidziil (Strong man) Intervention study is part of a larger project called, Community-Driven Indigenous Research, Cultural Strengths \& Leadership to Advance Equity in Substance Use Outcomes (CIRCLE) Center of Excellence. CIRCLE aims to address drug use related health problems in collaboration with diverse Indigenous communities. This study is a randomized controlled trial study to measure the effectiveness of a secondary prevention program, called Hastiin Bidziil (Strong Man), aimed at reducing substance use among Native American Indian (AI) men ages 18-26.


Eligibility Criteria:
Inclusion Criteria:

* Self-identify as American Indian
* Self-identify as a man
* Age 18-26 years at time of enrollment
* Screen positive for at least moderate risk on any substance, except for tobacco use only
* Reside within \~60 miles of a study community (Fort Defiance, AZ; Chinle, AZ)

Exclusion Criteria:

* Any condition that would affect successful participation (e.g., planned move)
* Profound disability that limits the ability to participate in assessments or interventions
* Participated in the preliminary phase of this study to adapt CETA for this project
Safety and Efficacy of AAE581 in Postmenopausal Women With Osteoporosis

This study will test the safety and efficacy of AAE581 in increasing Lumbar Spine bone mineral density (BMD) at 12 months, by Dexa-scan (DXA) in postmenopausal women with osteoporosis.


Eligibility Criteria:
Inclusion Criteria:

* BMD T Score between -2 to -3.5
* 50-75 years old

Exclusion Criteria:

* Urolithiasis
* Bisphosphonates

Other protocol-defined inclusion/exclusion criteria may apply.
Long-term Clinical and Radiographic Results of Revision Anterior Cruciate Ligament Reconstruction Using a Single-bundle Technique and External Tenodesis With Achilles Tendon Allograft.

Several techniques for revision of anterior cruciate ligament (ACL) reconstruction and different types of grafts have been used over the years. These include single-bundle techniques, double-bundle techniques, and single-bundle techniques with external tenodesis. We also distinguish between the use of autografts and grafts from donors, or allografts.

The choice of surgical technique and graft type is strongly influenced by the progression of damage characterizing these patients (meniscal, chondral, or ligamentous), the surgical decisions made during the initial surgery (graft used, orientation, and number of bone tunnels), or any complications that occurred.

The use of a specific type of graft is heavily dependent on its availability: it is likely that the first-choice graft for some surgeons may be unavailable because it has already been used. The use of allografts is now commonly accepted by the scientific community, with the Achilles tendon standing out for its biomechanical properties and size. Unlike autografts, it does not damage the patient's ligamentous tissue, which is thus preserved.

Since osteoarthritis is one of the most debated consequences of anterior cruciate ligament revision, an analysis of the results is essential to provide a clearer understanding of the risks and benefits associated with the different types of procedures.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 50 years at the time of surgery;
2. Male and female gender;
3. Patients who have undergone revision of anterior cruciate ligament reconstruction with a single-bundle "Over-The-Top" technique and external tenodesis using Achilles tendon allograft, with or without associated procedures, at least 2 years post-surgery;
4. A radiograph taken immediately before or after the surgery of the affected knee;
5. Patients who have provided consent to participate in the study.

Exclusion Criteria:

1. Patients no longer accessible;
2. Patients who deny consent to participate in the study;
3. Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery;
4. Severe obesity (BMI \> 35);
5. Lower limb conditions that prevent the patient from maintaining an upright position with full weight-bearing during the assessment;
6. Infection or hematological or rheumatic conditions at the time of the assessment.