cyrilzakka/clinical-trials huggingface dataset:
Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders

Chronic Obstructive Pulmonary Disease (COPD) is a lung-related disorder that is characterized by long-term, often progressive state of poor airflow. Primary symptoms include low oxygen tension, shortness of breath, productive cough, and broncho-pulmonary inflammation and interference with oxygen-carbon dioxide exchange.

Air pollution and tobacco smoking are felt to be the most common cause of these issues. Diagnostic testing is based on poor airflow measured by lung function studies and whose symptoms do not improve much with antiasthma bronchodilators.

Study is an interventional study to document the safety and efficacy of use of AD-cSVF in chronic broncho-pulmonary disease groups.

COPD is often treated by limiting exposure to poor air quality, but there is no cure at this time. Attempted therapy include smoking cessation, vaccinations, respiratory rehabilitation, and attempts of use of bronchodilators and steroids. Many resort to supplemental oxygen therapy, lung transplantation, and antibiotic supportive therapy during exacerbations.

As of 2013, COPD involve approximately 5% pf the global populations (approximately 330 million). Most commonly it occurs approximately equally between men/women and result in about 3 million deaths per year. Estimates of economic costs are estimated to be more than 2.1 trillion dollars in 2010.

This study includes microcannula harvesting of subdermal adipose tissues, incubation, digestion and isolation of AD-cSVF. This stromal cellular pellet (without actual extracellular matrix or stromal elements) is then suspended in 500 cc sterile Normal Saline (NS) and deployed via peripheral intravenous route. Evaluations of safety issues are measured at intervals (both severe and non-severe categories) and by repeated pulmonary function studies.

Eligibility Criteria:
Inclusion Criteria:

* Prior Diagnosis of moderate to severe COPD
* GOLD II a, III, IV

Exclusion Criteria:

* Pregnant or Lactating Females
* Life expectancy of \< 3 months due to concomitant illnesses
* Exposure to any investigational drug or procedure with 1 month prior to study entry or enrollment in concurrent study which may interfere with interpretation of study results
* Illness which, in investigators judgement, may interfere with the patient' ability to comply with protocol, compromise patient safety, ability to provide informed consent to study, or interfere with interpretation of study outcomes
* Subjects on chronic immunosuppressive or chemotherapeutic medications
* Known drug or alcohol dependence or other factors which may interfere with study conduct or interpretation of result or in the opinion of investigator are not suitable to participate.
* Subjects with documented Alpha-1 Antitrypsin Deficiency (Inherited lung and liver disorder)
* Unwilling or not competent to understand and execute an informed consent agreement
* Patients positive for Hepatitis (Hepatitis A history excepted)
Does Valproate Increase Levels of Folate Receptor Autoantibodies in Women?

Women who take folate (folic acid) before getting pregnant can lower the risk of giving birth to infant with certain birth defects. However, some medications may affect the action of folate. The purpose of this study is to compare the effect of two anti-epileptic drugs on how folate works in our body.


Eligibility Criteria:
Inclusion Criteria:

* Women ages 18-50 years inclusive who are taking valproate or lamotrigine for neurologic or psychiatric conditions
* Valproate of lamotrigine must be used as monotherapy at stable doses for 6 weeks prior to the study for the neurologic or psychiatric illness; medications taken for other reasons are not excluded.

Exclusion Criteria:

* Women with prior exposure to valproate or lamotrigine if they are taking lamotrigine or valproate respectively.
Different Surgical Techniques Used for Prolapse Repair in Elderly Patient

The investigator aimed to compare various pelvic floor repairs in female aged from 70 to 80 years old, to see which procedure in terms of treatment-related complications of SCP, VMR and NTR by comparing the operative and functional outcomes in this patient population.

Pelvic organ prolapse (POP) is a global health care issue that could have a significant impact on pelvic floor function and quality of life (QOL), while seldom having the potential to be life-threatening. Prevalence of POP increases with age. In women older than 80, 11% undergo a surgical procedure. The incidence of degenerative diseases and multiple co-morbidities increases with age, and advanced age is also associated with an increase in morbidity generally for gynecologic procedures. Furthermore, greater comorbidity beforehand can predispose patients to postoperative complications such as bleeding, hematoma, pain, infectious. As a result hospital stays are longer and the surgical results are compromised.

Surgical techniques should optimize functional results and minimize complications. In POP surgery, younger women are good candidates for sacrocolpopexy (SCP), because of the improved long term functional result, while women older than 80 may have a satisfactory outcome with fewer complication with a vaginal repair with mesh (VMR) or native tissue (NTR). The increasing prevalence of POP, and the increasing population of women aged 70-80 requires an evaluation of the appropriate surgical management since women in this age group may be candidates for all types of surgical repair.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a pelvic organ prolapse
* Patients aged between 70 and 80 years old
* Patients with symptomatic anterior, apical and/or posterior compartment prolapse, stage 2 or greater

Exclusion Criteria:

* Patients with a previous history of pelvic surgery for a cancer diagnosis are excluded
* Patients with a surgical repair specific to the existing defect site (For group 2)
Physiotherapy in Emergency Department: a Service Analysis From a French Hospital

The skills of physiotherapists have been employed to enhance access to optimal care in Emergency Departments (ED). No study has yet been conducted on the practices in France. The primary objective of this study was to describe the French practices of physiotherapy within an ED, and to secondary examine the effect on patient discharge.

A retrospective observational study was conducted on patients who received a referral for physiotherapy in the ED (E-PT) of the Universitarian Hospital of Nantes during a six-month observation period in 2022. A total of 461 medical records were extracted, including patient characteristics and the main chief complaint at the time of admission. Details on the delivery of E-PT were collected, as well as the end status at the exit of the ED. Descriptive statistics were performed to analyse the data. A propensity score analysis examined the association between the patients' status at the exit of the ED and E-PT.

Eligibility Criteria:
Inclusion Criteria:

* admission in the Emergency Departement
* aged over 18
* refferal for physiotherapy within the Emergency Department

Exclusion Criteria:

* death
* no admission within the Emergency Department (only administrative purposes)
Acupoint Stimulation Improves Cognition Under Hypoxia

Cognitive impairment is common in people who suffer from hypoxia. Acupuncture and related techniques can be used to improve hypoxia and treat cognitive impairment. In this trial the effect of transcutaneous electrical acupoint stimulation on cognitive impairment in people under hypoxia will be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Male, age from 18 to 50 years

Exclusion Criteria:

* cardiopulmonary dysfunction;
* History of severe respiratory, circulatory, digestive, blood, ear-nose-throat system diseases;
* A history of fever or respiratory infection within the last two weeks;
* Drinking alcohol or poor sleep within the last 24 hours
Elbow Outcomes Clinical Study (WELBOW)

WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF).

WELBOW study is an international, ambispective and prospective, single arm, multicenter, observational, non-comparative, Post-Market Clinical Follow-up (PMCF). Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR) and Clinical Evaluation Report (CER) on Elbow system devices and support peer-reviewed publications on long-term product performance and safety.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of the informed consent or the non-opposition (when applicable).
* Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
* Willing and able to comply with the requirements of the study protocol.
* For prospective inclusion: Considered for treatment with one Wright Medical Elbow arthroplasty or fracture devices included in this study (primary or revision).
* For ambispective inclusion

  1. Must have undergone an Elbow arthroplasty or fracture with one Wright Medical Elbow studied device between the date of the first Site Initiation Visit (SIV) and until 4.5 years prior this one in order to have at least the 5 years follow-up visit prospectively. Ambispective patients who were explanted prior the date of the first SIV will be included.
  2. Must have complete Information available for each completed visit (demographics, preoperative information, surgery information, device details)\*.

Exclusion Criteria:

* Not able to comply with the study procedures based on the judgment of the assessor (e.g. cannot comprehend study questions, inability to keep scheduled assessment times).
* Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred as "vulnerable subject" in the section 3.44 of the ISO 14155:2011 norm).
* Patient with previous elbow device(s) which remain(s) implanted.
Validation of Clinical Decision Support Tool for Acute Stroke Diagnosis (InstaDx)

This is a observational validation study. The Stroke Clinical Decision Support Tool ( InstaDx) , an information technology application will be adapted and developed in accordance to evidence based clinical practice guidelines ( Level IA). Neurology Residents will be using the InstaDx CDST to improve their diagnostic accuracy and the findings will be validated against the review of a stroke subject expert. The study hypothesis is that Clinical Decision Support Tool used by neurology residents will have an agreement of \>0.77 when compared to Stroke Expert (gold standard) in diagnosing type of ischemic stroke.

Overall Objective: To adapt, develop and validate the clinical decision support tool, an information technology application to assist acute stroke diagnosis for use among neurology graduate trainees compared to stroke expert (gold standard).

Specific Aims:

1. To validate the adapted clinical decision support tool, an information technology application to assist acute ischemic stroke diagnosis for use among neurology residents compared to stroke expert (Gold standard) in the adult population presenting at a tertiary care hospital in Pakistan.

The study will be conducted in Emergency department and the Neurology ward at Aga Khan University Hospital. The data collector will enroll the patients meeting the eligibility criteria and providing informed consent. Neurology residents will use the Clinical Decision Support Tool application to assist in acute stroke diagnosis. In the second part, the Stroke Expert will independently assess all diagnosis. The purpose of this would be to validate the Clinical Decision Support Tool application to assist in acute stroke diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1. Adult men and women, \>18 years of age.
2. Patients admitted with neurological deficit consistent with stroke.
3. Confirmation of stroke by objective modality of CT scan and MRI.
4. Consenting to participate in the study.

Exclusion Criteria:

1. Patients presenting with any type of Haemorrhagic stroke such as Sub-Arachnoid Haemorrhage, Intracerebral Haemorrhage and others.
2. Stroke due to any iatrogenic causes such as post-surgeries, trauma, or any rare or non atherosclerotic causes eg carotid dissection.
3. Patients signing LAMA (left against Medical Advice) and leaving undiagnosed
Primary HIV Prevention in Pregnant and Lactating Ugandan Women

This study aims to test the effectiveness of a behavioral intervention aimed at preventing the primary acquisition of HIV by uninfected pregnant and lactating women in Uganda, East Africa where HIV transmission is high. Women who acquire HIV during pregnancy or lactation are at higher risk of adverse health and pregnancy outcomes and their baby is at high risk of acquiring HIV and dying.

Keeping HIV-uninfected women uninfected during pregnancy and lactation is an important component of the global World Health Organization (WHO) strategy to eliminate mother-to-child transmission of HIV but there has been no study to date to assess interventions that can effectively keep these women uninfected.

In this study, the investigators will test the hypotheses that:

1. extended repeat HIV testing and enhanced counseling (ERHTEC) during late pregnancy (\>36 weeks) and breastfeeding can increase and sustain risk reduction behaviors and prevent incident STI and HIV infections among HIV-uninfected pregnant women, and
2. that couple HIV testing and counseling (HTC) can further enhance this effect through improved couple communication and emotional and economic support from male partners.

The specific aims of the study are:

* Aim 1: to assess the effect of an extended repeat HIV testing and enhanced counseling (ERHTEC) intervention on sexual risk behavior and sexually transmitted infections (STI) and HIV acquisition in HIV-uninfected pregnant and lactating women enrolled individually
* Aim 2: to assess the effect of ERHTEC on sexual risk behavior and the incidence of STI and HIV in uninfected pregnant and lactating women enrolled with their partner, and
* Aim 3: to assess the costs and estimate the cost-effectiveness of the intervention.

We will conduct a stratified randomized trial of 410 HIV-negative pregnant Ugandan women enrolled individually and 410 HIV-negative pregnant women enrolled with their male partners in Mulago Hospital, Kampala and St Joseph Hospital, Kitgum, Northern Uganda. In each site, 205 women enrolled individually and 205 couples will be randomized to be either retested and counseled for HIV in late pregnancy only (\>36 weeks) as per the WHO/Ministry of Health (MOH) recommendation, or to receive ERHTEC throughout pregnancy and breastfeeding.

Individual women and couples randomized to the intervention arm will receive the ERHTEC intervention at 3, 6, 12, and 18 months postpartum. Follow-up will end at 24 months postpartum or 6 weeks after the end of breastfeeding, whichever occurs first.

Eligibility Criteria:
Inclusion Criteria:

* Women: 15-49 years old, confirmed HIV negative, confirmed pregnant, living within 30kms /19 miles of hospital, willingness to sign informed consent
* Men: \> or = 15 years old, being an established partner of a woman participant, living within 30kms /19 miles of hospital, willingness to sign informed consent

Exclusion Criteria:

* condition requiring hospitalization
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.

OBJECTIVES:

* Determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year survival, in patients with locally advanced pancreatic cancer.
* Determine the toxicity of this regimen in these patients.
* Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo radiotherapy once daily five days a week for 5.5 weeks. Patients receive gemcitabine IV over 30 minutes followed by cisplatin IV over 1 hour twice a week for the first 3 weeks of radiotherapy. Beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 20-47 patients will be accrued for this study within 12-28 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed unresectable adenocarcinoma of the pancreas
* No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin
* Prior subtotal resection or gross residual disease

  * No microscopic residual disease only
* No metastatic disease outside of planned study radiotherapy field

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-1

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)
* AST no greater than 3 times ULN

Renal:

* Creatinine no greater than 1.5 times ULN

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to maintain adequate oral nutrition
* No significant infection
* No other medical condition that would preclude study
* No other malignancy within the past 5 years except non-melanoma skin cancer
* No significant nausea or vomiting

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior or concurrent biologic therapy

Chemotherapy:

* No prior chemotherapy
* No other concurrent chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* See Disease Characteristics
* No prior radiotherapy that would overlap planned study radiotherapy fields

Surgery:

* See Disease Characteristics
* At least 21 days since prior laparotomy
The Effect of Cognitive Function Training Program for Community Elderly

Background. Recently, cognitive function training program has been shown to improve cognitive function in elders. However, the effects of cognitive function training program on elderly living in the community have not been thoroughly evaluated.

Objective. The purpose of this study is to construct and evaluate the effects of cognitive function training program on cognitive function for community elderly.

Design. This is a randomized controlled study. Study subjects are elderly living in community. Subjects will be randomized into experimental group or active control group. The evaluation of the program will be evaluated at baseline, immediate after, 3 months, 6 months, and 1 year after the last session. The primary outcome indicators of the training is cognitive function, assessed by MMSE and MoCA.

Expected contribution. With rigorous design and long term follow-up, the effectiveness of cognitive function training program in Chinese population in Taiwan can be evaluated. Results of the current study will determine the value of the cognitive function training program and provide valuable information for future utilization of this protocol.


Eligibility Criteria:
Inclusion Criteria:

* 65 years old

Exclusion Criteria:

* TBI
Assessment of the Role of Tegaserod Therapy in the Management of Gastroesophageal Reflux Disease (GERD) Symptoms in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).

Study to assess the effects of tegaserod added to PPI therapy in the resolution of heartburn and regurgitation in patients with incomplete relief from PPIs .


Eligibility Criteria:
Inclusion Criteria:

* Heartburn for at least 3 days in the week prior to screening
* Regurgitation for at least 3 days in the week prior to screening
* Stable dose PPI therapy \> 4 weeks
* Incomplete relief on daily PPI therapy \> 4 weeks

Exclusion Criteria:

* Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
* Previous gastrointestinal surgery that may influence esophageal motor function
* Evidence of cathartic colon or a history of laxative use

Other protocol-defined inclusion/exclusion criteria may apply.
The Effect of Education and Telephone Follow-up Intervention Based on the Roy Adaptation Model

In this parallel randomized controlled trial (n = 33/group), the control group received routine care, while the intervention group received a telephone follow-up intervention, which consisted of a pre-discharge education program and three telephone follow-up sessions based on the Roy Adaptation Model.

Objective: To evaluate the effect of education and telephone follow-up intervention based on the Roy Adaptation Model (RAM) for improving MI patients' self-efficacy, quality of life and lifestyle adaptation.

Methods: In this parallel randomized controlled trial (n = 33/group), the control group received routine care, while the intervention group received a telephone follow-up intervention, which consisted of a pre-discharge education program and three telephone follow-up sessions based on the RAM. Data were collected before discharge, and in the 12th week after discharge included quality of life, coping adaptation process, self-efficacy and lifestyle changes.

Eligibility Criteria:
Inclusion Criteria:

1. Participants were adults aged ≥30 years and had been admitted to the hospital with a diagnosis of MI (which must be supported by ECG and an increase in biomarkers).
2. were clinically stable
3. willing to participate
4. able to understand and write Turkish
5. able to receive telephone calls or fill in questionnaires.
6. able to come to the hospital for checkups. Exclusion Criteria:Patients were excluded from the study if according to medical file records they had chronic renal failure, cancer, heart failure, severe aortic stenosis, if they were planned for surgical treatment or had chronic cognitive and psychiatric disease, if they had problems with hearing and speaking on the phone, or if they had mobility restriction.