cyrilzakka/clinical-trials huggingface dataset:
A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers

The objective of this double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to:

* Comparison of total helper and suppressor T-cell number between the groups.
* Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups.
* Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.


Eligibility Criteria:
Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Opportunistic infections or Kaposi's sarcoma.
* Critical illness.
* History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Concurrent Medication:

Excluded:

* Steroids.
* Cytotoxic immunosuppressive agents.

Concurrent Treatment:

Excluded:

* Radiotherapy.

The following are excluded:

* Opportunistic infections or Kaposi's sarcoma.
* Critically ill patients.
* Patients receiving steroids, cytotoxic immunosuppressive agents, and/or radiotherapy.
* Patients who have received any other immunotherapy.
* Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Prior Medication:

Excluded:

* Any other immunotherapy.

Patients who fall into the group which is at risk of developing cutaneous sarcoma and/or opportunistic diseases but at present have no signs or symptoms of these diseases.
Nutrition and Cancer Outcomes in Shaanxi Chemoradiotherapy

The study investigates the impact of nutritional status on the clinical outcomes of cancer patients in Shaanxi Province undergoing chemoradiotherapy. It focuses on understanding how diet and nutrition affect the effectiveness and side effects of cancer treatments.

Study Purpose and Content: The research aims to investigate the nutritional status and trends in cancer patients at different stages of chemoradiotherapy in Shaanxi Province.

Registry Procedures: The study will recruit patients from 20 hospitals across the province, tracking their nutritional status, disease condition, and quality of life through various stages of treatment.

Quality Control: Nutritional assessments are to be conducted at specific intervals, and all research staff are required to undergo training for consistency in data collection and patient evaluation.

Ethical Considerations: The study ensures informed consent from participants and confidentiality of personal information, with approval from the ethics committee of Xi'an Jiaotong University Medical College.

Data Collection and Analysis: Data will be gathered through detailed patient surveys, laboratory tests, and physical measurements, with subsequent analysis to establish a predictive model for cancer patient survival based on nutritional indicators.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years and above
* Pathologically diagnosed with malignant tumors
* Scheduled to undergo radiotherapy and/or chemotherapy
* Clear consciousness, no communication barriers
* Willing to undergo follow-up, not in a near-death condition

Exclusion Criteria:

* Patients without a pathological diagnosis of malignant tumors
* Patients with AIDS
* Patients with mental or cognitive disorders
* Patients who have undergone organ transplantation
* Patients with a life expectancy less than 12 months
* Pregnant women
* Patients currently participating in other clinical intervention studies
Longitudinal Non-invasive Analysis of VOCAle Cord Function Based on Trans-laryngeal Ultrasound Acquisitions and Voice Recordings

The main objective of VOCALISE study is to propose a new approach allowing a better characterization of postoperative dysphonia. This involves associating with dynamic translaryngeal ultrasound optimized acquisitions of the vibration of each vocal fold in phonation simultaneously with voice recordings. A software program to analyze the displacement of arytenoids, markers of substitution of the vocal cords, will be developed to finely quantify the mobility of laryngeal structures, by combining classical methods of motion analysis and deep learning methods.

This approach will be evaluated to follow speech therapy rehabilitation in patients with post-operative dysphonia following recurrent nerve injury.

Dynamic translaryngeal ultrasound (dTLUS), a non-invasive and inexpensive technique, has emerged in recent years as an alternative to nasofibroscopy for assessing vocal cord paralysis. This paralysis is the major risk (3 to 5%) associated with cervical surgery (100,000 procedures per year in France). Initial work by our consortium has demonstrated the performance of dTLUS after thyroid or parathyroid surgery in the early diagnosis of vocal cord paralysis. The aim of VOCALISE is to propose a new approach for better characterisation of post-operative dysphonia. This involves combining optimised dTLUS acquisitions with acquisitions of the vibration of each vocal cord during phonation, simultaneously with voice recordings. Software will be developed to analyse the displacement of the arytenoids, which are surrogate markers for the vocal cords, in order to quantify the mobility of laryngeal structures in fine detail, using a combination of conventional motion analysis methods and deep learning methods.

This approach will be evaluated to monitor speech therapy rehabilitation in patients with post-operative dysphonia following a lesion of the recurrent nerve.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Obtaining patient's free and informed consent
* Patients with dysphonia following cervical surgery and referred for speech therapy
* Social security scheme membership (beneficiary or entitled), excluding MA

Exclusion Criteria:

* Known preoperative history of recurrent nerve paralysis (PR)
* History of laryngeal or vocal cord tumour
* Surgical complications preventing proper assessment of postoperative vocal cord mobility (tracheotomy, tracheal resection).
* Patients with a history of thyroid or parathyroid surgery or cervicotomy for another pathology
* Patient under guardianship or guardianship or deprived of liberty or under safeguard of justice
* Pregnant or nursing patient
* Patient does not read or has vision problems
* Cognitive and/or auditory impairment preventing
Impact of an Exercise Program for Children Aged 4 to 6 Years With Bronchopulmonary Dysplasia

The purpose of this study is to determine the effects of a physical activity program for children with Bronchopulmonary Dysplasia.

Primary objectives is: to compare exercise tolerance and aerobic capacity between healthy children with Bronchopulmonary Dysplasia children Only Bronchopulmonary Dysplasia children will realise the physical activity program.

Secondary objectives are: to analyse lung function and to evaluate flexibility.

Eligibility Criteria:
Bronchopulmonary Dysplasia Children

Inclusion Criteria:

* age between 4 to 6 years old
* Bronchopulmonary Dysplasia diagnostic
* ex-prematurity
* accept to participate.

Exclusion Criteria:

* congenital malformations
* neuromuscular disorders
* gait alterations
* difficulties for communication and understanding
* wheezing or pulmonary disease two weeks before to start the program
* hemodynamic changes (heart rate \> 130bpm, systolic blood pressure \> 130bpm, diastolic blood pressure \> 80bpm).
* heart and/or lung transplantation.

Healthy children Criteria:

Inclusion Criteria:

* age between 4 to 6 years old.

Exclusion Criteria:

* antecedents of pulmonary or cardiac chronic disease
* congenital malformations
* neuromuscular disorders
* gait alterations
* difficulties for communication and understanding
* wheezing or pulmonary disease two weeks before to start the program
* hemodynamic changes (heart rate \> 130bpm, systolic blood pressure \> 130bpm, diastolic blood pressure \> 80bpm).
* heart and/or lung transplantation.
Home Plate: A Trial to Improve Home Food Preparation Practices Among Parents of Toddlers

This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children.

Barriers to healthy eating and active living are at the heart of the obesity epidemic. This study focuses on a key factor underlying healthy eating: home food preparation. This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children. The investigators will partner with community-based organizations serving families with children ages 1 to 3 years in West Philadelphia aiming specifically to:

1. Test the intervention's effect on diet and physical health.

   Hypothesis 1: The intervention group will have improved home food preparation practices and a healthier diet compared to the control group.
2. Test the intervention's effect on family health.

   Hypothesis 2: The intervention group will report improved parenting skills and more hopeful patterns of thinking.
3. Identify factors present at baseline and during engagement with the intervention that distinguish intervention participants who have improved diet, physical health, and family health from those who do not.

Eligibility Criteria:
Inclusion Criteria: mentees

1. English-speaking
2. Able to give informed consent.
3. Legal guardian and caregiver of at least one child, age 1-3 years

Inclusion Criteria: children

1. 1-3 year old children of mentee primary caregivers enrolled in the study
2. If a mentee caregiver has more than one child, then all their eligible children (ages 1-3 years) will be enrolled in the study.

Inclusion Criteria: peer mentors

1. Eligible peer mentors should meet the inclusion criteria set forth above for mentees. (Children of peer mentors will not be eligible for this study.)

   In addition,
2. The study team will decide which participants will be invited to be peer mentors, based on attributes including interest, leadership ability, and home food preparation skills.

Exclusion Criteria

1. Caregivers and children not meeting the inclusion criteria above.
2. Caregivers who are pregnant at the time of enrollment.
3. Caregivers or children with a medical condition that significantly affects their diet or eating habits. (The study team will ask during the time of recruitment if subjects or their children have a medical condition that significantly affects diet or eating habits.)
4. Subjects who, in the opinion of the Investigator, may be unable to participate in the study schedules or procedures.
The Effect on EPCs by Successful Cardiac Occlusion Device Implantation

All patients awaiting to have either a left atrial appendage closure (LAA) or patent foramen ovale (PFO) or Atrial Septal Defect (ASD) closure device as part of standard care will be identified and reviewed in cardiology clinics. These patients will be placed on waiting list to undergo the procedure. Patient-participants will be consented on the date of admission for device closure implantation.

The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD closure and 10 patients undergoing LAA closure. EPC will be measured on the day of the device implantation, day 0 and prior to discharge on day 1.

Patient participants are admitted overnight after the device closure implantation. Then on subsequent out patient cardiology research clinic follow appointments on days (3-4) and (7-8).

The objective of this study is to assess the effect, if any, on EPC count and cardiac device implantation.

All patients awaiting LAA or PFO/ASD occlusion will firstly be reviewed in a cardiology clinic and assessed. Suitable patients will then be placed on a waiting list for occlusion device implantation and therefore identified as potential participants in the study. Patient-participants will be informed of the trial and given a chance to participate, this may be by face to face and or via invitation letter. All patient-participants will be given a copy of the patient information sheet.

Formal consent to participate in the trial will occur on the morning of the procedure. This will avoid repeated visits by patients that may have to travel some considerable distance.

The study will recruit 20 patients divided into; 10 patients undergoing PFO/ASD occlusion and 10 patients undergoing LAA occlusion. EPC will be measured on the day of the device implantation, day 0 and prior to discharge on day 1, then on subsequent follow up appointments on days (3-4) and (7-8). Blood samples of 3-5ml will be taken to allow flow cytometric analysis for EPCs.

Standard follow up for participants may include transesophageal echocardiography (TOE) at 3 months after implantation. This will give a direct assessment of device related thrombus. Currently TOE is not standard of care in PFO follow up. If a TOE result is available for either group the investigators will use the results in our study.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 and over and suitable for cardiac device closure

Exclusion Criteria:

* Patients unable to give informed consent or attend follow up
Development and Preliminary Trial of a Brief, Portable Health Intervention for Rural Sexual Minority Emerging Adults

The purpose of this study is to test the feasibility of writing interventions specifically designed for lesbian, gay, and bisexual (LGB) emerging adults (ages 18-29) that are aimed at improving the outcomes: depression, suicidality, substance abuse and HIV risk behaviors.

This study is considered the third part ("Phase 3") of a larger study where parts one and two were designed to utilize elicitation focus groups to develop effective intervention materials (Phase 1) and then refine the developed materials through structured interviews (Phase 2). Phase 3 will test feasibility and assess early signs of efficacy of writing interventions. To do this, participants will be randomized to one of three arms (one arm will serve as control). Those that choose to participate will be asked to complete outcome measures (depressive symptoms, suicidality, use of alcohol and illicit drugs, HIV risk behavior) and measures of proposed mediators (self-reported and biological stress, behavioral and emotional self-regulation) and moderators (e.g., social support, identity centrality) at baseline, post-intervention, and three-month follow-up. In addition, structured interviews with 15 intervention participants will be used to refine study procedures as the investigators scale up this intervention for a future randomized controlled trial (RCT).

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as lesbian, gay, or bisexual
* Live in Washington county, Tennessee (TN), or any of its 6 contiguous counties in northeastern TN
* Have personal Internet access
* Hair at least 2cm in length

Exclusion Criteria:

* Failure to meet inclusion criteria
Baduanjin Lower Elevated Blood PreSsure Study

The aim of this study is to evaluate the effects of Baduanjin on blood pressure in individuals with high normal blood pressure (SBP 130-139 mmHg, and/or DBP 85-89 mmHg), as well as on glucose and lipid metabolism, quality of life, psychology, exercise, immune inflammation, endothelial function, and arterial stiffness.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 years or older;
* Systolic blood pressure (SBP) \<140 mmHg and diastolic blood pressure (DBP) \<90 mmHg
* SBP 130-139 mmHg, and/or DBP 85-89 mmHg

Exclusion Criteria:

* Diagnosis of hypertension (SBP≥140 mmHg, and/or DBP ≥90mmHg）
* History of cardiovascular diseases, such as coronary heart disease, heart failure, stroke, and peripheral vascular disease
* Diagnosis of chronic kidney disease, primary aldosteronism, Cushing's syndrome, or pheochromocytoma
* Newly diagnosed cancer or cancer metastasis within 5 years
* History of autoimmune disease
* Having taken antihypertensive drugs or immunoregulators within 2 weeks
* A long-term need for antihypertensive drugs or immunomoregulators
* Unable to maintain moderate intensity exercise due to illness or other reasons
* Pregnant, breastfeeding, or planning to become pregnant within the next 1 year
* Currently taking regular exercise (at least 30 minutes of moderate-intensity exercise at least three times a week)
* Allergic to sports bracelets
* Having participated or been participating in other clinical trials within the last 3 months
* Unable to use smartphones
* Other factors that may affect the follow-up, such as alcohol or substance abuse in the last 12 months, planing to live out of town for a long time, or diagnosis of dementia or cognitive impairment which indicates incapability of completing the study
* Unable to accurately measure blood pressure using the sphygmomanometer provided by the study due to a too large or too small arm circumference
Southern Bone & Joint Study - Brimless Sockets

The investigators are comparing a new type of prosthetic socket for above knee amputees to the standard of care. The hypothesis is that the new type of socket will show equivalence to the standard of care using our designated outcome measures.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral transfemoral or knee-disarticulation amputee
* 18 to 85 years of age
* K3 (variable cadence and community) ambulators;
* Be able to independently provide informed consent
* Be willing to comply with study procedures.

Exclusion Criteria:

* History of chronic skin breakdown on the residual limb
* Conditions that would prevent participation and pose increased risk (e.g. unstable cardiovascular conditions that preclude physical activity such as walking)
* Use of any assistive devices/walking aids, beyond a prosthesis, to ambulate
* Unwillingness/inability to follow instructions
Assessment of the Cerebral Perfusion During the Period of Deep Hypothermia at 18°C in Patient Undergoing Pulmonary Endarterectomy Surgery.

Cardiopulmonary bypass (CPB) surgery present risk of acute postoperative neurological complications. These complications are most often postoperative cognitive dysfunction (confusion, cognitive disorders, executive disorders) with a prevalence of up to 40% at 5 years, and ischemic (stroke) with an incidence of between 0.4 and 14%. The causes are usually multifactorial, but altered cerebral perfusion during CPB surgery is an important prognostic factor. Data regarding the effect of deep hypothermia on cerebral perfusion during CPB in adult are scarce. Currently, aortic arch replacement following aortic dissection or aneurysm, and pulmonary artery endarterectomy (PAE) in the treatment of pulmonary hypertension of post embolic origin are performed under deep hypothermia.

In this latter indication, the need to obtain a completely bloodless operating field necessitates complete circulatory arrest during short period of time to enable the surgeon to optimally remove the clot materials located into the pulmonary arteries.

To protect the brain and avoid irreversible brain injury during circulatory arrest(s), body temperature is lowered at 18-20°C. Deep hypothermia can lead to significant arterial vasoconstriction, which can reduce the blood supply to the brai. It also increases the solubility of CO2 in the blood, leading to respiratory alkalosis, which can also lead to vasoconstriction of cerebral vessels, increasing the risk of ischemic lesions.

In adult there is no consistent data on the cerebral perfusion during PAE surgery under deep hypothermia at 18-20°C. Animal studies showed that cerebral regulation seems to be preserved under these conditions. A better understanding of the effect of deep hypothermia on cerebral perfusion during PAE surgery is essential to adapt our management to limit the occurrence of postoperative neurological complications.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for pulmonary artery thromboendarterectomy surgery.
* Patient with free, written and informed consent.
* Patient affiliated to a social security scheme (beneficiary or beneficiary's beneficiary).
* French-speaking patient.

Exclusion Criteria:

* Patient refusing to participate in the study.
* Patient under guardianship.
* Patient deprived of liberty.
* Pregnant or breast-feeding women.
A Study With Pentasa in Patients With Active Crohn's Disease

The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD.


Eligibility Criteria:
Inclusion Criteria (main):

* Age: at least 18 years
* CD symptoms/onset of disease: ≥ 3 months prior to Visit 1
* Ileal, ileo-colonic or colonic non-stricturing/non-penetrating disease
* A confirmed location of CD (by MRI, X-ray (small bowel and/or colon), and/or endoscopy)
* A Harvey-Bradshaw score between 5 and 12
* Males and non-pregnant, non-nursing women
* Mild to moderate active CD, defined by a CDAI score between 180 and 350
* Active inflammatory disease (C-Reactive Protein (CRP) level above or equal to 5 mg/L), or a biopsy verified inflammation, or fecal calprotectin level above or equal to 50 µg/g)
* Estimated creatinine clearance should be above 75 ml/min

Exclusion Criteria (main):

* Any significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may influence the results of the trial or the patient's ability to participate in the trial
* CD located to the upper gastrointestinal tract and/or jejunal part of the small intestine, and/or to colon below the left colon flexure and/or isolated proctitis and/or anal disease
* Prior treatment resistance to Pentasa (mesalazine)
* Chronic, dominant arthralgia or rheumatoid arthritis
* Palpable abdominal mass
* Biologics (eg anti-TNF-α) must not be used during the trial or 6 months before Visit 1
* Continuous usage of systemic steroids (excluding budesonide) for 3 months or more within the past year
* Positive pregnancy test
Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer

Considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy. The objective of the study is to show that long term grade\>2 late toxicity is acceptable and similar to published data using hypofractionated technique in the prostate only.


Eligibility Criteria:
Inclusion Criteria:

* pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions:
* Clinical Stage \>T3 or
* Gleason Score 8 or higher, or
* PSA level \>20ng/ml
* Study entry PSA must be obtained within 6 weeks prior to protocol entry
* ECOG \<2
* Age \>18
* History and physical examination within 3 months
* Bone scan and CT scan of the abdomen and pelvis within 3 months with no evidence of bone metastases and no pelvic lymph nodes larger than 1.0cm, unless biopsy negative.
* CBC with differential within 6 weeks prior to protocol entry
* Absolute neutrophil count \>2000cells/mm3
* Hemoglobin \>8.0 g/dl (the use of transfusion to increase the Hg is acceptable)
* Testosterone level within 6 weeks of protocol entry
* Liver function tests
* Signed informed consent
* Prior use of hormonal therapy for prostate cancer is acceptable if less than 2 months.

Exclusion Criteria:

* Prior use of hormonal therapy for prostate cancer for more than 2 months. Previous use of finasteride or dutasteride is allowed.
* Prior invasive malignancy (except non-melanoma skin) unless disease-free for more than 5 years.
* Prior radiotherapy to the pelvis
* Life expectancy of less than 2 years.