cyrilzakka/clinical-trials huggingface dataset:
Research on Equity in Abortion Care by TeleHealth

This study will examine the ways in which telehealth for reproductive healthcare affects timing, costs, and follow-up care; whether telehealth reaches people in areas with greater health inequities; and the attributes of telehealth that patients want. Study surveys will be administered to interested, eligible participants: 2,000 patients seeking abortion care will complete the study, comprising of 2 groups: patients seeking medication abortion care either (1) in-person or (2) via telehealth. This project will address how telehealth services can be optimized for people of color, low-income people, and immigrants to increase digital inclusion and health equity.

Given the novelty of telehealth abortion services and new abortion bans, there is a critical need for research on the role of telehealth for abortion to expand equitable abortion access among groups historically marginalized in healthcare. Outside of abortion care, telehealth appears to 1) bridge geographic disparities,2) facilitate language translation,3) provide privacy and safety for immigrants with varying legal statuses, 4) decrease patient costs, and 5) require less time off work or school. At the same time, telehealth services could exacerbate inequities if patients lack technology, internet connectivity, or digital literacy. Because abortion is overregulated and highly stigmatized, research on telehealth for abortion is vital. The investigators hypothesize that telehealth is associated with several benefits compared to in-person abortion care, but is not yet reaching people in areas with greater health inequities who need these innovations most. This research can also inform the policies in states that are considering ways to support people in banned states.

Eligibility Criteria:
Inclusion Criteria:

* Must be currently or about to be obtaining medication abortion care through in-person or telehealth services

Exclusion Criteria:

* Not currently or about to be obtaining medication abortion care through in-person or telehealth services
MAKv1 Exoskeleton for TKA Patients: a Safety, Usability and Clinical Effects Trial of an Early Intervention

The present study analyzes the effects of using a portable single limb exoskeleton (MAKv1) in patients with total knee artrhoplasty (TKA). Safety, usability and clinical effects of an early intervention program with the device with an early implementation are studied.

The present study will analyze the safety, usability and clinical effects of using the MAKv1 exoskeleton in TKA patients. The intervention will consist of 1 hour sessions with the MAKv1 device, thrice per week during 1 month. Safety measurements (serious adverse events, vitals, and auto-perceived pain) will be collected at each session with the device, along with the repetitions performed at each exercise assisted with the device. After the first week is completed, measurements regarding clinical effect will be collected. Also, at the end of the month were the participants receive the sessions with the device, clinical effects will be measured again, along with a questionnaire to collect the users' perception of the device (QUEST 2.0).

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing TKA surgery

Exclusion Criteria:

* inability to understand simple instructions
* postoperative complications that may be a risk to use the exoskeleton
* other conditions that prevented mobilisation in early stages after TKA
* weight \> 100 kg
* size \< 150 cm
* size \> 190 cm
Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions

The study will evaluate and refine a breast screening and diagnosis device.

The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.

Eligibility Criteria:
Inclusion Criteria:

* To participate in this research study you must be a female over the age of 25
* Have had a normal mammogram or are scheduled for a breast biopsy
* Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy.

Exclusion Criteria:

* Male
* Under the age of 25
* Documented breast cancer
Does Pantoprazole Reduce the Anti-platelet Effect of Clopidogrel?

The investigators sought to evaluate the influence of pantoprazole, indicated as less effective than other proton pump inhibitors, on the antiplatelet effect of clopidogrel, with stratification of the population according to the presence of cytochrome (CYP) 2C19 polymorphism.

Participants being treated with a maintenance dose of 75 mg clopidogrel and 100 mg aspirin daily after previous PCI with coronary stenting were included in the study. Participants were randomly assigned to either the pantoprazole 40 mg once-daily group or the ranitidine 150 mg twice-daily group using a computer-generated randomized table. An independent investigator generated the random allocation sequence. Blood samples were collected at 9:00 on day prior to treatment (day 0) and on day 9. Measuring impedance was performed by one independent investigator in a blinded manner.

Eligibility Criteria:
Inclusion Criteria:

* Patients being treated with a maintenance dose of 75 mg clopidogrel and 100 mg aspirin daily after previous PCI with coronary stenting were included in the study. All patients received standardized therapy with a loading dose of 600 mg of clopidogrel hydrogen sulfate and 400 mg aspirin.

All participants had a normal platelet count (150,000-450,000/mL).

Exclusion Criteria:

* Patients with severe liver disorders, current gastrointestinal disorders, a current infection, congestive heart failure, or a known bleeding disorder as well as patients on bivalirudin or glycoprotein IIb/III antagonists within the last 7 days were excluded from the study.
Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair

Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand.


Eligibility Criteria:
Inclusion Criteria:

* Peripheral Nerve Injury

Exclusion Criteria:

* Peripheral Neuropathy
* Allergic to Bovine products such as Bovine Collagen Nerve Cuff
A Clinical Study to Evaluate the Efficacy of Two Siddha Drugs Sindhuvallathy Mezhugu and Kalladaippu Kudineer for Kidney Stones

This study is a non randomized non comparative study with two Siddha formulations Sindhuvallathy Mezhugu and Kalladaippu Kudineer are available in Siddha classical texts existing for longer period. But there is no scientific data is documented about these formulations. This study aimed to evaluate the efficacy of the study drugs for urolithiasis. After the preliminary drug standardization the clinical study is Started at The National Institute of Siddha Tambaram. The primary outcome measure is either the Expulsion of stones or Changes in the number and size of the stones with 45 days drug treatment.

Objectives:

Primary Objectives. To assess the efficacy of sindhu vallathy mezhugu and Kalladaippu kudineer in Urolithiasis.

Secondary objectives

1. To standardize the study drugs.
2. To observe the adverse effects if any

Methods of proposed research:

The consists of two segments Part - A. Non- clinical studies -standardisation of the study drugs. Part - B. Clinical studies.

Study drugs

1. Sindhu Vallathy mezhugu will be prepared as per the literature Agasthiar vaidhya vallathy 600.
2. Kalldaippu Kudineer will be adapted from Athmaraktchamirtham Ennum Vaidhya Sarasangeeragam, 1968,page 349, 2.Siddha formulary of India part-II

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* both gender
* diagnosed ultrasonographically/radiographically with visible calculi of \>5mm
* with or without clinical symptoms .

Exclusion Criteria:

* Patients with severe pain and not responding to pain killers
* Bilateral Calculi obstruction requiring immediate surgery,
* Existing renal failure,
* Pregnant and lactating women,
* Age\<18 years,
* known hepatic and cardiac diseases,
* Subjects those who are not willing to give informed consent
* Women those who are planning for pregnancy .
Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula

Breastfeeding is the recommended diet for all infants during the first half of infancy and is associated with numerous health benefits. However, when breastfeeding is not possible, an infant formula is the only nutritive alternative. Formula-fed infants have a different growth pattern compared to breastfed infants. Studies have shown that the higher protein content in infant formula compared to breastmilk results in a more rapid weight gain and an increased risk of overweight and obesity in childhood. For this reason, both quantity and quality of protein in infant formulae have been optimized during the last decade, to better meet the needs of infants and to support growth close to that of breastfed infants.

Protein hydrolysis, a common modification of infant formulae, has originally been developed for treatment of cow's milk protein allergy. Certain hydrolysed formulae have been suggested to prevent atopic eczema when given to infants with a family history of allergic disease but as of yet, the allergy preventive effect in infants without increased risk of allergic disease has been little studied. Partially hydrolysed infant formulae have also been suggested to reduce common functional gastrointestinal symptoms in infants.

New protein hydrolysates are continually developed for use in infant formulae, with the aim of reducing allergenicity, while ensuring optimal growth and development of infants. It is important to study the effects on growth and health outcomes in infants who are fed formulae based on these newly developed hydrolysates as compared to those fed standard intact protein formulae or breastmilk.

The overall aims of the current study are to evaluate the effects of two new hydrolysates on growth, immunological biomarkers, neurodevelopment, protein metabolism and gut microbiota in a randomized, controlled clinical trial of healthy infants. In compliance with European Food Safety Authority (EFSA) regulations for novel infant formulas based on hydrolysed protein, the primary outcome is change in weight standard deviation score (SDS) from baseline until 5 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Healthy infants born at term
* Birth weight 2500 to 4500 gram
* Either exclusive breast-feeding (reference group) or exclusive formula-feeding (intervention and control group)

Exclusion Criteria:

* Suspected or verified food allergy
* Suspected or verified infant colic
Incidence and Severity of Acute Respiratory Distress Syndrome (ARDS) in the French Wounded Soldiers

The purpose of this study is to evaluate the incidence of the ARDS in the French wounded soldiers.

The Acute Respiratory Distress Syndrome (ARDS) complicates war wounds. Among the repatriated wounded persons, it can appear in the first 7 days.

It has been well described among American soldiers and it is known that it's serious, frequent and multifactorial.

However, not a single study has described the frequency and the severity of the ARDS in French wounded soldiers.

Thus the purpose of this study is to estimate the incidence and severity of the ARDS among the French wounded soldiers, admitted in continuing care and intensive care unit between 2001 and 2017.

The analysis of this data collection will let us improve the medical care of the ARDS in Outside Operation.

Eligibility Criteria:
Inclusion Criteria:

* Patient evacuated from the theatre of outside operation and hospitalized in intensive care unit in France between 2001 et 2017

Exclusion Criteria:

* Opposition to the use of personal data
PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery

RATIONALE: New imaging procedures such as fludeoxyglucose F 18 PET scan may improve the ability to detect cancer or recurrence of cancer.

PURPOSE: Clinical trial to study the effectiveness of fludeoxyglucose F 18 PET scan in diagnosing primary or recurrent cervical cancer in patients who are undergoing surgery.

OBJECTIVES:

* Assess the feasibility of using fludeoxyglucose F 18 (FDG) positron emission tomography (PET) imaging in patients with primary or recurrent cervical cancer.
* Investigate the ability of FDG-PET scan imaging to detect lymph node metastases in these patients.
* Investigate the ability of FDG-PET imaging to identify locally advanced disease in early stage cervical cancers.
* Compare FDG-PET to CT scan imaging with respect to distinguishing between postradiation pelvic fibrosis and recurrent cervical cancer.
* Investigate the ability of FDG-PET to identify recurrent cervical cancer.

OUTLINE: This is a diagnostic study.

Patients with primary cervical cancer receive fludeoxyglucose F 18 (FDG) intravenously followed 45 minutes later with positron emission tomography (PET) imaging over 60 minutes, as well as computed tomography (CT) scan. Both diagnostic imaging techniques are to assess the abdomen and pelvis, and must be done within 2 weeks prior to surgery. Patients eligible for surgery undergo radical hysterectomy and lymphadenectomy and all specimens are evaluated for correlation with the preoperative diagnostic tests findings.

Patients with recurrent cervical cancer obtain FDG-PET scan and CT scan of the thorax, abdomen, and pelvis prior to surgical exploration for pelvic exenteration. All biopsy specimens are evaluated for correlation with diagnostic tests findings.

PROJECTED ACCRUAL: A total of 30 patients (20 patients with primary cervical cancer and 10 patients with recurrent cervical cancer) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Must meet one of the following criteria:

  * Histologically confirmed primary invasive squamous carcinoma or adenocarcinoma of the cervix
  * History of cervical cancer suspected of being recurrent
  * Known diagnosis of recurrent cervical cancer being considered for pelvic exenteration

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No insulin-dependent diabetes mellitus
* No active serious infection not controlled by antibiotics
* Must tolerate being in the scanner for the duration of the study
* Not mentally retarded
* No prisoners
* Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Not specified
Banded Versus Non-banded Roux-en-y Gastric Bypass

A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.

A Roux-en-Y Gastric Bypass (RYGB) is on the long term not always successful in every patient because weight regain can occur. An intervention to prevent weight regain in the future is to place a silicone band (non-adjustable) around the pouch of the RYGB (Banded-RYGB: BRYGB) which increases weight loss and decreases weight regain on the longer term. The question is whether primary application of a banded bypass gives a greater weight loss and / or prevent weight regain in the future versus a standard RYGB.

The Study design is a prospective, randomized, single center study.

Study population: patients who qualify for a RYGB are eligible to participate. The primary RYGB patients may participate if there is a BMI of 35 kg / m2 with a morbidly obesity-related comorbidity or a BMI of 40kg / m2 or higher.

Intervention: The standard RYGB with a vertical pouch over a 40 french feeding tube with a volume of 30-50 ml, is compared with a banded-RYGB (BRYGB)

Eligibility Criteria:
Inclusion Criteria:

* all patients who are eligible for a primary RYGB

Exclusion Criteria:

* Bariatric surgery in history
* Patients with a language barrier which may affect the compliance with medical advice
* Any kind of genetic disorders which can be of influence on the monitoring of medical advice
* Patients with a disease not related to morbid obesity, such as Cushing or drug related.
* Chronic bowel disease for example Crohn's disease or colitis Colitis.
* Renal impairment (MDRD \<30) or hepatic dysfunction (liver function twice the normal values)
* Pregnancy
* Patients with treatment-resistant reflux symptoms. Defined as reflux persistent symptoms despite the use of a minimum dose of proton-pump inhibitors
A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity

The purpose of this study is to compare the effects of oral oxybutynin and intradetrusor injections of botulinum toxin type A on urodynamic parameters and quality of life in patients with neurogenic detrusor overactivity following spinal cord injury.


Eligibility Criteria:
Inclusion Criteria:

* Spinal cord injury
* Detrusor overactivity
* Age over 18 years
* Spinal cord injury at least 12 months duration
* Undergoing regular clean intermittent catheterisation

Exclusion Criteria:

* Pregnancy
* Desire to become pregnant during the study period
* Breastfeeding
* Blood coagulation disorder
* Neuromuscular transmission disorder
* Use of any intravesical pharmacologic agents
* Previous use of botulinum toxin A
Cognitive-Behavioral Therapy in Veterans With Schizophrenia

This is a study comparing the benefits of two types of individual psychotherapy (cognitive-behavioral therapy for psychosis and supportive therapy) in symptomatic Veteran outpatients diagnosed with schizophrenia or schizoaffective disorder. Treatment lasted approximately 6 months, with outcome data on symptoms, functioning, and distress levels collected at baseline, post-treatment, and 6 months post -treatment follow-up.

This is a randomized controlled trial comparing 6 months of participation in one of two active treatments, cognitive-behavioral therapy for psychosis or supportive therapy in symptomatic Veterans diagnosed with schizophrenia or schizoaffective disorder who are still symptomatic. Assessments of clinical status and social functioning were obtained at baseline, end of treatment, and 6 month follow-up. We hypothesized that participation in the cognitive-behavioral therapy would lead to greater reductions in symptoms and distress about symptoms, and more improvements in social functioning.

Eligibility Criteria:
Inclusion Criteria:

* outpatients with schizophrenia or schizoaffective disorder in proximity to the West Los Angeles VAMC
* at least one month since last hospitalization
* stable antipsychotic medication with persisting psychotic symptoms with at least minimal distress
* competent to sign informed consent.

Exclusion Criteria:

* in other individual psychotherapy
* presence of organic brain disease
* mental retardation
* illness that would prohibit regular attendance in therapy
* substance dependence diagnosis in the past 6 months.
Immediate vs. Delayed Postpartum Etonogestrel Implant

The investigators are examining if there is a difference in continuation rates of the etonogestrel contraceptive implant between women who have the device placed immediately after delivery, before leaving the hospital, and women who have the device placed at the routine 6-week postpartum visit. There will be 60 subjects total, randomized in a 1:1 ratio, for 30 in each group. All participants will follow-up at the same postpartum clinic 6 weeks after delivery. They will then be contacted at 3, 6, and 12 months postpartum and asked to complete a brief survey. The investigators hypothesize that continuation rates of Implanon will be higher in the immediate postpartum placement arm than in the delayed placement arm.


Eligibility Criteria:
Inclusion Criteria:

1)Age 12-40 years 2)Must deliver at Duke Hospital 3)Must have a working telephone number 4)No contraindications to receiving this method of contraception, which include: known or suspected pregnancy, active liver disease or hepatic tumor, current or past history of thrombosis or thromboembolic disorder, undiagnosed abnormal genital bleeding, known or suspected breast cancer or history of breast cancer, hypersensitivity to any of the components of the device.

-

Exclusion Criteria:

1. Not meeting inclusion criteria
2. Use of chronic medical therapy that has an adverse interaction with etonogestrel. Medications that will be cause for exclusion from the study include:

1. Non-nucleoside reverse transcriptase inhibitors 2. ritonavir-boosted protease inhibitors 3. Certain anticonvulsants - phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine 4. Rifampin 5. St. John's Wort

-
Auricular Acupuncture for Pain Relief After Ambulatory Knee Arthroscopy

The aim was to investigate whether auricular acupuncture is superior to sham acupuncture in relief of acute postoperative pain and in reduction of analgesics consumption on demand and their side effects in patients after ambulatory knee arthroscopy


Eligibility Criteria:
Inclusion Criteria:

1. Patients with an American Society of Anesthesiologists physical status of I to II scheduled for ambulatory knee arthroscopy under general anesthesia.
2. Surgery time does not exceed 60 minutes.
3. Patients without previous opioid and/or psychiatric medication.
4. Patients ranged 16-65 years old.
5. Patients able to use Visual Analogue Scale-100 for pain intensity measurement.
6. Patients who have given informed consent.

Exclusion Criteria:

1. Pregnant or nursing females.
2. Recidivist alcoholics and/or patients with history of psychiatric disease.
3. Local or systemic infection.
4. Age \< 16 and \> 65 years.
5. Surgery time more than 60 minutes.
6. Inability to use Visual Analogue Scale-100.
7. Patients consumed opioid medication before surgery.
8. Patients with prosthetic or damaged cardiac valves (s. Potential risks)
9. Patients who are unable to understand the consent form.
TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study

The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS


Eligibility Criteria:
Key Inclusion Criteria:

1. Subject is 18 years old or older;
2. Patient willing and able to provide a signed Patient Informed Consent Form;
3. Has a midline primary ventral, umbilical or incisional hernia;
4. Scheduled for a laparoscopic IPOM hernia repair;
5. Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect

Key Exclusion Criteria:

1. Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures);
2. BMI \> 40;
3. Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day;
4. Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent;
5. Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding;
6. Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;
7. Patient has more than one hernia defect (to be confirmed intraoperatively);