cyrilzakka/clinical-trials huggingface dataset:
Pilot Study to Improve Care Coordination

The purpose of this study is 1) to learn how VA patients can help share their health information between their VA providers and providers outside the VA and 2) if sharing this information is useful to providers and improves care received.

Recent studies estimate that 43 to 75% of Veterans also receive care from non-VA providers (dual use). Dual use is a concern because splitting care between two or more health systems and multiple providers may result in poor coordination of services and a loss of continuity -ultimately putting the patient at increased risk for poor outcomes. Addressing dual use in Veterans is an issue of care coordination. One component of care coordination is information sharing, which often relies on the patient to share information between systems/providers. Veterans registered in My HealtheVet with premium account status have access to download and print a VA health summary (VA CCD). This health summary can be shared with non-VA providers to inform them about recent VA care. This pilot randomized controlled trial will compare usual care to an intervention which aims to improve care coordination for dual use Veterans by educating them about the use of information technology to share health information and informing their providers about the extent and nature of care from other health care systems.

Methods: Dual use Veterans with at least one chronic health condition and both an upcoming VA and non-VA appointments within the study time frame will be eligible to participate. Veterans will be randomized to the intervention or usual care. Veterans in the intervention group will be trained on use of My HealtheVet and their community patient portal (if applicable) to access summary health information to share with providers. In addition, he/she will create a document that lists all members of their health care team. All participants will be asked to take a provider evaluation packet each provider visit (VA and non-VA). After the visit, a phone call will be scheduled with the Veteran to ask about the appointment and medical records from the appointment will be obtained. Outcomes: The main outcomes will be related to patient perceived continuity of care, provider relational coordination survey, medication concordance, and medical laboratory test duplication. Pre and post scores on the patient activation measures will also be explored.

Eligibility Criteria:
Inclusion Criteria:

VA Patient

* Receives health care from VA and non-VA provider
* Diagnosed with a chronic health condition
* Prescribed 5 or more medications
* Upcoming VA and non-VA appointments within the study time frame
* Registered or willing to become registered with My HealtheVet
* Access to a computer with internet, phone, and a printer.
* English speaking

VA or Non-VA Providers: provide care to a stuy participant

Exclusion Criteria:

* Previously shared health data with a provider via their My HealtheVet or local provider patient portal
* No scheduled VA or non-VA appointments
Cystoinflation to Prevent Bladder Injury in Obstetrics and Gynaecology Surgery

Part1:The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions will be found during their operation. Adhesiolysis will be performed using bladder retro-fill with 300cc saline in the cystoinflation group, and without retro-fill in control.Both groups will be observed for bladder injury rate,bloodloss,operativetime,urinary tract infection,micturition problems and fistula formation.

Part2\&3:Summary of Part 2 and 3 will be provided after publication

Part1:Investigators will conduct this study to find the effectiveness of cystoinflation to prevent bladder injury in women with adhesions of previous C-sections. This prospective analytic longitudinal study will be conducted in Lady Willingdon Hospital, a tertiary care teaching hospital affiliated with King Edward Medical University Pakistan, from August 2017 to July 2019, after approval by the institutional review board of King Edward Medical University, Pakistan. The subjects will be randomly allocated to cystoinflation and control groups. The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions will be found during their operation. Adhesiolysis will be performed using bladder retro-fill with 300cc saline in the cystoinflation group, and without retro-fill in control. We will assess primary outcome by observing bladder injury rate, blood loss and operative time. The secondary outcome will be assessed by Urinary tract infection, micturition problems and fistula formation during 3month follow up period. The cystoinflation will be considered effective if the proportion of bladder injury in the study group will be less than 50% of the control group.

Part2\&3:Details of part2\&3 will be provided after publication

Eligibility Criteria:
Part1:Inclusion Criteria:

* • Healthy pregnant women of any age

  * Two or more previous C-sections
  * Gestational age between 38-40 weeks (confirmed by dating scan)
  * Dense Adhesions of Tulandi scores four or more.
  * women who give informed consent to participate in the study

Exclusion Criteria

:• Patients with medical disorders

* Bladder injury before group assignment
* Placenta previa
* Subjects experiencing micturition problems (dysuria, frequency, urgency, urinary retention, incontinence) before the study.

Eligibility criteria of part 2\&3 will be provided after publication -
Effects of Pentoxifylline After Cardiac Surgery

Acute Kidney Injury (AKI) is a common and serious post operative complication and may occur in up to 50% of all patients undergoing cardiac surgery and is associated with 8% mortality rate compared with 0.9% in non-affected patients and remains a major factor for post surgery adverse outcomes. Early interventions to prevent postoperative AKI can help decreasing morbidity and mortality in these patients. Using cardiopulmonary bypass during cardiac surgery triggers systemic inflammatory response and recruits pro-inflammatory cytokines such as tumor necrosis factor, interleukin -10 (IL-10) and Interleukin-6 (IL-6) accompanying with production of free oxygen radicals which provokes oxidative stress in the milieu of ischemic reperfusion injury. Pentoxifylline as a non-specific phosphodiesterase inhibitor, can suppress the production of some factors of inflammatory response and oxidative stress, probably prevent post surgery AKI with these mechanisms.

This is a double blind randomized multicenter clinical trial, enrolling 100 consecutive patients undergoing elective Coronary Artery Bypass Graft Surgery (CABG). Patients randomly and within concealment method divided into two groups, one to receive oral pentoxifylline 400 mg every 8 hours from three days before surgery and the other group received placebo. All the intubation , surgery and weaning protocols were the same.

Eligibility Criteria:
Inclusion Criteria:

* The elective CABG candidate

Exclusion Criteria:

* refusal to sign the consent,
* collagen vascular disease,
* use of immunosuppressive agents, corticosteroids (\> 3 days), methylxanthines, diltiazem or sodium nitroprusside,
* angiography in the past 7 days,
* hemorrhagic diathesis and coagulopathy,
* uncontrolled diabetes mellitus
* sepsis
* renal failure (sCr \> 2 mg/dl),
* hepatic failure (AST (Aspartate transaminase) or ALT(alanine transaminase) \> 40 U/L)
* urinary tract infection.
Healthy Volunteer Study of Sildenafil Effects Upon Vision

Patients sometimes report subjective visual effects when taking sildenafil. Our study set out to measure these in a controlled setting. Subjects were asked to detect patterns presented on a monitor screen.


Eligibility Criteria:
Inclusion Criteria: male -

Exclusion Criteria:

-
Chromosomal and Morphological Structure of Mature and Immature Male Germ Cells and Recognition of IL-18 in Testicular Tissue of Azoospermic Men

To develop a biotechnological assay which will be able to recognize germ cells of the spermatogenic lineand and to identify the chromosomal and morphological structure of mature and immature male germ cells, in cases of of sperm production disorders(azoospermic patients).

To recognize IL-18 in testicular tissue of azoospermic men compared to control group as it has been suggested that this cytokine may serve as a paracrine defense factor in the male gonad associated to spermatogenesis.

A new biotechnological assay was developed by adapting an existing computerized system which scans cell morphology and chromosomal ploidy in the same cell of hematologic line using digital technology, to recognize germ cells of the testis by their morphology and cytogenetics. Testicular tissues which obtained from 15 men were enzymatically digested and the cells received were fixed on slides. The cells were stained by Giemsa May Grinwald staining and scanned automatically in a bright field for cell morphology. Fluorescence in situ hybridization (FISH) using centromeric probes for chromosomes X, Y and 18 was performed on the same slide after destaining. The cells were automatically scanned and classified according to the ploidy of the chromosome signals. The presence of IL-18 in the same men's testis was examined parallelly, by immunohistochimical staining using specific antibody for human IL-18.

Eligibility Criteria:
Inclusion Criteria:

* Non-obstructive azoospermic patients

Exclusion Criteria:

* Obstructive azoospermia
Break-through Infection Following Mpox vaccinatIon

The purpose of this study is to assess the protection of smallpox preexposure vaccination against infection with mpox in real-world individuals with risk factors for mpox.

A Target Trial Emulation study that tries to emulate the sequential specification of a target trial will be conducted measuring and controlling confounders when there is a common cause of vaccination and outcome event.

Participants will be provided with a Quick response (QR) code to access the RedCap study platform, which will guide them to the enrolment process. If the participant accepts and meets all the inclusion and none of the exclusion criteria, they will be directed to a baseline survey to self-collect sociodemographic data and information regarding risk factors, sexual behaviour, vaccination, and exposure to mpox.

Newly vaccinated participants will be matched 1:1 to unvaccinated controls. The matching will be performed based on the site of recruitment, and self-reported baseline sexual health and practices. Vaccinated and unvaccinated participants will be matched on variables associated with the probability of infection.

Follow-up will include regular surveys every month from the index date (i.e., enrolment date in the unvaccinated group, or vaccination date for the vaccinated group), to collect data on change on risk factors, sexual behaviour in the past month, vaccination status, and exposure to mpox. The participant will be asked to self-report if they develop symptoms suggestive of mpox, and the study platform will direct them to a specific mpox infection survey.

For each participant, follow-up will end at the earliest of the following events: mpox infection, voluntary withdraw, or the end of the study period. A health record review will be conducted to corroborate the diagnosis of new cases and to provide validity to the self-report.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 18 years or older.
2. Individuals with general risk factors for mpox infection, as currently defined by the local guidelines for vaccination. These risk factors include at least one of the following items:

   * Individual-reported use of HIV pre-exposure prophylaxis (PrEP).
   * Individual-reported chemsex practices
   * Individual-reported multiple sexual partners.
   * Individuals with a history of a sexually transmitted infection (STI) in the past year.
   * Individuals living with HIV infection.
3. Signature of informed consent.

Exclusion Criteria:

1. Unable to provide signature of informed consent.
2. Past infection with monkeypox.
3. Past smallpox vaccination.
Study of Brain Function in Women With Insulin Resistant Polycystic Ovary Syndrome

The purpose of this study is to evaluate the effects of insulin resistance on brain function in women with Polycystic Ovary Syndrome (PCOS). PCOS affected women will be evaluated prior to and following 4-month treatment with Metformin. Additionally, brain function in women with PCOS will be compared to the brain activity in normal control subjects with regular menstrual cycles.

The pathogenesis of Polycystic Ovary Syndrome (PCOS), a reproductive and metabolic disorder, is associated with insulin resistance. The effects of insulin resistance on cognition, mood, opioid system and reproductive function in PCOS affected women are investigated in the current study. The identification of reversible changes in brain function and reproductive measures in insulin resistant PCOS patients would likely significantly influence treatment protocols for these young women.

1. Evaluate the differences in opioid tone in women with insulin resistant PCOS compared to normal controls.
2. Evaluate whether an oral hypoglycemic agent is capable of altering opioid tone in women with insulin resistant PCOS.

Eligibility Criteria:
Inclusion Criteria:

* Insulin-resistant PCOS (Arm: PCOS Affected Women)
* Irregular menstrual cycle (Arm: PCOS Affected Women)
* Hyperandrogenism (Arm: PCOS Affected Women)
* Regular menstrual cycles (Arm: Normal Controls)
* Normal hormonal levels (Arm: Normal Controls)
* Lack of hirsutism (Arm: Normal Controls)
* Acne-free (Arm: Normal Controls)
* Candidates are BMI-matched and screened for insulin resistance prior to inclusion. (Arm: Normal Controls)

Exclusion Criteria:

* Left handedness
* Acute medical illness
* Uncorrected thyroid disease
* Diabetes renal
* Cardiac or pulmonary insufficiency
* Active liver disease
* Neurological disease
* Current psychiatric illness
* Claustrophobia
* Contraindications to MRI
* Smoking
* Use of hormones
* Centrally acting or insulin sensitizing mediations
* Allergy to any opioid medication
* Substance abuse
* Pregnancy
* BMI \>35.
Assessment of Bone Mineral Density in Patients With Subclinical Hypothyroidism

This study aims to recognize the effects of subclinical hypothyroidism on bone mineral density, Not many studies were done on this subject

A lot of different factors are necessary for the harmonious development as well as normal functioning of skeleton: genetic conditions, hormonal and metabolic homeostasis, balanced diet, mechanical load. Any disturbances of those agents can lead to serious and dangerous consequences like length reduction, deformations, and fractures. Their results depend, between other, on one's age, type of disorder and its duration.

* There are a lot of endocrinological reasons of secondary osteoporosis (for example: Cushing's syndrome, hyperparathyroidism, hypogonadism, acromegaly, diabetes mellitus, hypothyroidism etc..

Any changes of normal thyroid function and Thyroid stimulating hormones (TSH) directly affects the remodeling of bone through TSH receptor found on osteoblast and osteoclast precursor cells.

TSH has a positive correlation with body mass index (BMI) in women; though, this correlation is insignificant in male. Women having subclinical hypothyroidism have reduced femoral neck bone mineral density (BMD). The variations in thyroid function are primary, while changes in body weight and bones are secondary. The physiological variation of thyroid hormones is associated with changes in BMD and non vertebral fracture risk in healthy postmenopausal women.

The definition of osteoporosis by the world health organization (WHO) is densitometric and non-clinical and is based on the measurement of bone mass and dexa method in the spine or hip. There is still controversy about the relation between thyroid hormones, osteoporosis and BMD in female hypothyroid patients. This study aims to fill the gaps in our understanding of impact of subclinical hypothyroid disorder on bone densitometry.

Eligibility Criteria:
Inclusion Criteria:

- All adult patients with subclinical hypothyroidism with the level of TSH values above 4.0 mU/l.and normal values of thyroxine (T4) and triiodothyronine (T3).

Exclusion Criteria:

* Diabetes mellitus
* Cushing
* hyperparathrodisim
* CKD .patients on corticosteroid therapy.
* Inflammatory conditions as rheumatoid arthritis,Systemic Lupus, Crohn's disease, ulcerative colitis
* Haematological conditions as multiple myeloma, Myeloproliferative disorders
* Vitamin D deficiency
* Males aged more than 55 years old
* Postmenopausal females will also be excluded in this study
Three-month Chan-Chung Qigong Improves Physical Function Performance and Quality of Life

The purpose of this study aimed to evaluate the effect of the three-month Chan-Chung qigong program in improving physical functional performance and quality of life in patients with mild to moderate cognitive impairments.A quasi-experimental design was adopted. Subjects were recruited from cognitive impairments outpatients these subjects,41were assigned to the control group and 41 to the experimental group in which Chan-Chuang qigong was administered.

This study randomized controlled trial with four repeated measurements was conducted between Apply 2016 and October 2017. Participants in the Qigong group were given a structured program about Chan-Chung qigong for 3 months; those in the control group received usual care for cognitive impairment during the same study period. The intervention effects were measured by muscular strength, muscular endurance, and 6-min walk distance at baseline, Month 1, Month 2, and Month 3. In addition, QoL was measured at baseline and Month 3.

Eligibility Criteria:
Inclusion Criteria:

* Participants invited in this study were aged more than 60 years, diagnosed with the Clinical Dementia Rating (CDR) ≦1, able to communicate, free to stand and walk, and willing to participate this study.

Exclusion Criteria:

* The exclusion criteria were as followings: use of hormone drugs, brain trauma, head surgery, vitamin B12 deficiency, decreased memory and judgment due to hypothyroidism or malnutrition with medical contraindications for exercise, and practicing qigong or exercise regularly.
Prevention of Residual Low Back Pain After Percutaneous Kyphosis(PKP) Using Posterior Branch Block of Spinal Nerve

The purpose of this study was to block the posterior branch of lumbar spinal nerve during PKP operation and compare it with the patients without spinal nerve block, so as to verify the effect of posterior branch block of spinal nerve in relieving short-term and long-term residual low back pain after operation.

Patients older than 60 years old who underwent Percutaneous kyphosis(PKP) surgery for osteoporotic fractures were randomly divided into two groups. The lumbar spinal nerve branch was blocked with betamethasone and ropivacaine in the experimental group during PKP operation, while the lumbar spinal nerve branch block was not performed in the control group during PKP operation. The low back pain was evaluated at 1 week, 2 weeks, 1 month, 3 months and 6 months after operation using Visual analogue pain score(VAS)scale.So as to compare the effect of lumbar spinal nerve block on residual pain after PKP.

Eligibility Criteria:
Inclusion Criteria:

* osteoporotic fracture
* acute vertebral compression fracture (within 2 weeks)
* fracture level lower thanT6

Exclusion Criteria:

* other types of fractures
* patients younger than 60 years of age,
* with other disease (metabolic bone disease, metastasis, uncor- rectable coagulopathy, spinal infection, severe cardiopulmonary comorbidity, cognitive disorders etc)
Ketamine and Postoperative Analgesia in Children

The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). Caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.


Eligibility Criteria:
Inclusion Criteria:

* Children between 6 months to 6 years of age
* American Society of Anesthesiologists (ASA) I or II
* Undergoing elective surgery with intraoperative caudal analgesia

Exclusion Criteria:

* ASA III or IV
* Contraindication to caudal anesthesia
* Allergy to drugs used in the study
* Failure in caudal puncture
* Administration of morphine derivative
Safe Traction During Ongoing Lead Extraction Procedure (STOP)

The study will evaluate (in-vitro) the forces that are typically used for the extraction of pacemaker or defibrillator electrodes.


Eligibility Criteria:
Inclusion Criteria:

* Experience in pacemaker and defibrillator lead extraction

Exclusion Criteria:

* none
Joining Under-connected Networks to Optimize "Salud" (Health) ("JUNTOS")

The objective of this study is to evaluate the JUNTOS Referral Network as an implementation strategy to enhance the reach of HIV-prevention and treatment services to Latino gay, bisexual, and other men who have sex with men (MSM).


Eligibility Criteria:
Inclusion Criteria:

HIV Test counselors:

* 18 years of age or older
* Certified as an HIV test counselor in Miami-Dade County or Broward County (at the time of enrollment)
* Working or volunteering as an HIV test counselor in Miami-Dade County or Broward County and report testing 1 or more Latino MSM client per week (at the time of enrollment)
* Plans to continue working or volunteering as an HIV test counselor in Miami-Dade County or Broward County for the next 6 months
* Reports suboptimal fidelity to pre-exposure prophylaxis (PrEP) referral guidelines (\<90% fidelity) and/or self-reports an unmet need for HIV prevention/treatment referral resources
* Willing and able to recruit 4-5 Latino MSM testing clients into the study

Latino MSM:

* 18 years of age or older
* Identifies as Latino/a/x or Hispanic
* Identifies as a sexual minority man or reports being a man who has sex with men
* Speaks English and/or Spanish
* Received an HIV test from an HIV test counselor participating in the study
* Lives in Miami-Dade County, Broward County, or Palm Beach County and anticipates living there for the next three months

Exclusion Criteria:

HIV test counselors:

* Unable to consent
* Study personnel unable to verify HIV test counselor role in Miami-Dade County or Broward County (e.g., confirmation of where they work/volunteer as HIV test counselor, location they state they provide services doesn't exist or does not provide HIV testing services)
* Works as an HIV test counselor in an incarceration/prison setting (i.e., clients are prisoners)

Latino MSM:

* Unable to consent