cyrilzakka/clinical-trials huggingface dataset:
Connect for Caregivers

Connect for Caregivers is a intervention feasibility pilot study. The purpose of the study is to pilot test a newly developed single session behavioral intervention to help caregivers of individuals with Alzheimer's Disease or related dementias gain understanding of the importance of increasing social connectedness, awareness of their personal barriers to connectedness, and knowledge of local resources for promoting connectedness.

Connect for Caregivers is a intervention feasibility pilot study. We use a mixed methods approach to initiate the development and testing process for a single session behavioral intervention to help caregivers gain understanding of the importance of increasing connectedness, awareness of their personal barriers to connectedness, and knowledge of local resources for promoting connectedness. The intervention-"Connect 4 Caregivers"-has three components: 1) psychoeducational materials on the importance of connectedness for health and wellbeing; 2) a card sort-based 'discussion prioritization tool' that systematizes and routinizes the process of identifying and prioritizing barriers to connectedness; 3) personalized resources to address the identified barriers/targets.

Aim 1 is to investigate whether Connect for Caregivers is associated with a signal for efficacy for changing connectedness by having n=5 caregivers complete the single session intervention and provide quantitative and qualitative data on their experience with the intervention and motivation to work on increasing their social connectedness (a signal for potential efficacy).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 50 yrs;
2. English speaking;
3. Caregiver (age 50 or older) for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia;
4. Elevated caregiving distress: Above population mean (\>11) on 10-item Perceived Stress Scale (PSS-10) and/or at least moderate caregiver strain (score \>= 5) on the Modified Caregiver Strain Index (MCSI).
5. Social connectedness: UCLA Loneliness Scale: Short Form score of \>5.

Exclusion Criteria:

1. Primary language is not English;
2. Current problem drinking on the AUDIT-C (score of 5 or greater indicating exclusion);
3. Current non-alcohol psychoactive substance abuse (MINI Neuropsychiatric Interview), psychotic disorders (current and lifetime, MINI), bipolar disorder (MINI), and current mood disorder with psychotic features (MINI);
4. Significant cognitive impairment (MOCA \<22); and
5. Hearing problems that preclude completion of the intervention.
Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis

The effect of two isometric exercises is measured on Cobb angles from films taken 4-10 months apart.

The investigators obtained baseline Cobb angles on simple and complex curves, and collected previous, earlier studies of each adolescent idiopathic and degenerative scoliosis patient. The investigators then taught them to do the side-plank pose with the convex side of lumbar and thoracolumbar scoliotic curves downward, and a slightly altered version of the the half moon pose of yoga with the convex side of thoracic and cervicothoracic curves downward. The half moon pose was altered in that a belt was looped around the horizontal leg's foot, and held in a vertically extended upper arm's hand, and pulled tightly in that vertical position.

Each pose was held as long as the patient could at least once daily.

Cobb angles were again measured in films taken 4-10 months later.

Eligibility Criteria:
Inclusion Criteria:

* Scoliosis
* Willingness to do pose at least once daily for 4 -10 months
* Willingness to have a second X-ray 4-10 months after starting to do pose

Exclusion Criteria:

* Neuromuscular disease
* Previous Spinal surgery
* Pregnancy
Response of Pulmonary Functions to Deep Breathing Exercise in Twin Pregnancy

this study is to investigate the response of pulmonary function to deep breathing exercise in twin pregnancy

Physiological changes during pregnancy impose numerous changes on the respiratory system that can affect the health of both mother and foetus. Regarding the importance of the normal breathing in the health of mother and foetus.

Many investigators have studied pulmonary function tests during normal pregnancy, most of them found a significant decrease in pulmonary function test parameters during all pregnancy trimesters. Others showed that the PFTs parameters are normal in the first trimester but there was significant decrease in them in the second and third trimesters, or in the third trimester only.

Study Design: Randomized control trial Sixty twin pregnant women during the third trimester i (27th weeks gestation),aged 25 to 35 years old and body mass index was ≥ 30 kg/m², will participate in this study. They will be assigned into two equal groups; control group and study group ( study group only will make deep breathing exercise inform of diaphragmatic and costal breathing 3times a day for 15 repetitions each exercise for 9 weeks, pulmonary function test will be applied for both groups at 27th week gestation and at 36th weeks gestation.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women will be in 27th week gestation
* They will be recruited from Soaad kafafy university hospital
* Their age between 25-35 years old
* Their BMI ≥30Kg/m2

Exclusion Criteria:

* Pregnant women with any pulmonary disorders before pregnancy
* Women suffering from any physical or mental disorders.
* Pregnant women with gestational diabetes
* Pregnant women with gestational hypertension
* Pregnant women with asthma
Betamethasone Dosing Interval - 12 or 24 Hours?

The purpose of this study is to determine if there may be a benefit to the newborn if betamethasone is given 12 hours apart instead of 24 hours apart.

Betamethasone is a medicine given to women expected to deliver after 24 but before 34 weeks of pregnancy. It is very advantageous in preventing or decreasing the many problems these small babies may face if born early. Betamethasone makes breathing easier for them, also decreases the chance of them bleeding in the head and makes their chances of survival better. This medicine is used routinely in pregnancy but the best timing between doses in not well established. The 'standard' dosing schedule involves giving 2 injections of 12mg of the medicine 24 hours apart. However, many women deliver before reaching the 24-hour mark, despite the doctors best efforts to try and delay delivery, and therefore miss the opportunity for the 2nd dose.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women expected to deliver preterm (either induced or spontaneously) for any obstetrical or medical indication.
* Gestational age between 23 and 34 weeks gestational age.
* Dating must either be by LMP which is consistent with ultrasound performed at any gestational age, or calculated by a sonogram less than or equal to 23 weeks.

Exclusion Criteria:

* Patients at \<23 or \>34 weeks gestational age.
* Known drug allergy to betamethasone.
* Given steroid other than betamethasone for lung maturation.
* Any contraindication to steroid therapy.
Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease

OBJECTIVES:

I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron disease.

PROTOCOL OUTLINE:

All patients receive androgen suppression with leuprolide acetate injections every 4 weeks for 6 months, plus hormone replacement therapy with testosterone enanthate injections every week for 24 weeks.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Men aged 18 and over with motor neuron disease, i.e.:

* X-linked spinal and bulbar muscular atrophy (Kennedy's disease)
* Confirmed by androgen receptor, exon-1 mutation genotype
* Amyotrophic lateral sclerosis
* Spinal muscular atrophy

Significant muscle weakness on manual muscle testing

No prisoners

No mental disability
Photobiomodulation Therapy on Pain and Range of Motion Following Flexor Tendon Repair

The purpose of the study was to evaluate the therapeutic effect of low-level laser in improving pain and ROM following flexor tendon repair surgery.

Flexor tendon injury is a common issue requiring early postoperative mobilization. Prolonged immobilization can lead to complications such as muscle atrophy, joint stiffness, osteoarthritis, infection, pain, joint cartilage ulceration, joint contracture, and tendon rupture. Low level laser therapy has been shown to accelerate inflammation, promote fibroblast proliferation, regulate procollagen messenger ribonucleic acid synthesis, accelerate bone repair and remodeling, encourage wound revascularization, and accelerate tissue repair. This study aims to evaluate the effectiveness of Low level laser therapy in pain management and improving range of motion after flexor tendon repair.

Eligibility Criteria:
Inclusion Criteria:

* Forty-four patients of both genders with age ranged between 20 to 50 years will participate in this study.
* All patients with zone II and III flexor tendon injuries, will be suffered from pain following flexor tendon repair surgery.
* All patients with zone II and III flexor tendon injuries, will be suffered from limitation of range of motion deficiency following flexor tendon repair surgery
* All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

* A wound in the affected area
* Rheumatoid arthritis.
* Epilepsy or any psychological disorders
* Myelopathy or radiculopathy
* exposed hand tendons.
* Concomitant finger fractures, joint injuries, replantation or revascularizations, extensor tendon injury or crush injuries.
* Impairment of cognitive, perceptual or psychological function that would impede ability to follow verbal instruction.
* Multiple injuries to one flexor tendon, simultaneous injuries to bone and extensor tendons, skin loss, noncompliant patients or patients under 10 years, and gross contaminations of wounds.
* patients with tendon repair associated with a skin graft, nerve injury, arterial injury, systemic disease (e.g. diabetes mellitus), wound infection,
ACAM2000® Myopericarditis Registry

The purpose of this registry is to study the natural history of vaccination-related myocarditis and pericarditis and to assess possible risk factors for these conditions.

Primary Objective:

- To document the natural history of confirmed, probable, suspected, and subclinical myocarditis and pericarditis (myopericarditis) following ACAM2000® vaccination.

Other Pre-defined Objective:

- To look for potential predictive factors for the prognosis of myopericarditis following ACAM2000® vaccination.

All participants will have received previous vaccination with ACAM2000 but will not receive any vaccination as part of the registry. All participants enrolled in the registry will be followed for 2 up to 5 years (depending on whether there are persisting signs and symptoms of myopericarditis).

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are current or former members of the active duty, Reserve, or National Guard, from any branch of service
* Documented vaccination with ACAM2000® vaccine
* Meet one of the case definitions for suspect, probable, confirmed or subclinical myopericarditis.

Exclusion Criteria:

* Individuals not meeting at least one of the case definitions for myopericarditis will not be entered into the Registry.
Analysis of Intestinal Microbiota as a Predictor of Response to Treatment of Spondyloarthritis With Biotherapy

Spondyloarthritis (SpA) is a group of inflammatory rheumatic disorders that mainly manifested by inflammatory pain of the spine, pelvis and sometimes limbs. Classically, SpA has been classified into several subtypes, such as ankylosing spondylitis (AS), psoriatic arthritis (PsA), inflammatory bowel disease (IBD)-associated.

Several studies have shown specific changes in the gut microbiota during SpA. A recent, uncontrolled study suggested that the therapeutic response to anti-TNFα (Tumor Necrosis Factor) therapy could be predicted by analysis of the gut microbiota.

The purpose of the study MEDIBIOTE 3 is to confirm that in SpA, the composition of the intestinal microbiota at the initiation of treatment is predictive of the response to treatment with biotherapy (anti-TNFα / anti-IL17).


Eligibility Criteria:
Inclusion Criteria:

For patient with spondyloarthritis:

* Diagnosed for spondyloarthritis or pure axial or axial type psoriatic rheumatism according to Assessment of Spondyloarthritis International Society (ASAS) criteria.
* Requiring treatment with anti-TNFα or anti- IL-17 according to the treatment recommendations of the French Society of Rheumatology (SFR)
* patient not previously treated with biotherapy
* Aged ≥ 18 years
* Having given free and informed written consent
* Being affiliated to the center national security system social

For control Subject:

* Healthy volunteers without diagnosis of spondyloarthritis or any other chronic disease.
* Aged ≥ 18 years
* Having given free and informed written consent
* Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

* Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within one month before stool sampling.
* Association with another chronic pathology
Comparison of Argon Laser and Radiofrequency in Trichiasis Treatment

In this clinical trial study,the investigators intend to compare two methods of trichiasis treatment.One by argon laser and the other by radiofrequency then compare the result of these procedures, especially, the investigators would like to compare which of these have less complications such as bleeding,pain,notch in the site of surgery and etc.


Eligibility Criteria:
Inclusion Criteria:

* All patients who came to labbafinejad oculoplastic clinic due to trichiasis

Exclusion Criteria:

* Having a history of entropion
* Any history of previous laser ,radiofrequency therapy or surgery
* More than 50% of the area is involved with trichiasis
* More than 10 eye lashes need to be treated
EASH Dressing on Chronic Venous Leg Ulcers

The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.


Eligibility Criteria:
Inclusion Criteria:

* Subjects over 18 years, willing and able to provide written informed consent.
* Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater
* Subjects who have a venous leg ulcer (i.e. CEAP classification of C6 1), with duration less than 24 months and size ranging between 5 cm2-40 cm2.
* Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs of infection: pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour (foul odour), and heavy exudate.
* Subjects who agree to wear compression therapy daily in combination with the trial dressing.

Exclusion Criteria:

* Subjects with a history of skin sensitivity to any of the components of the study product.
* Subjects who have had current local or systemic antibiotics in the week prior to inclusion with the exception of wounds that are considered to be clinically infected at baseline.
* Subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
* Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents
* Subjects exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study
* Subjects who have participated in a clinical study within the past month.
Chemotherapy Options for the First Line Chemotherapy in Elderly Patient With Advanced Gastric Cancer

The investigators compare the overall survival between combination chemotherapy and monochemotherapy as a first-line chemotherapy in elderly patients with metastatic or recurrent gastric cancer. The investigators also compare the progression free survival, response rate, safety, and, quality of life between two groups, and evaluate that the comprehensive geriatric assessment tested at baseline can predict the toxicity and compliance of treatment, survival of the patients.


Eligibility Criteria:
Inclusion Criteria:

* .Metastatic or recurrent, histologically confirmed adenocarcinoma of stomach - Previously untreated patients, including patients with previous adjuvant chemotherapy completed more than 6 months
* 70 yrs or older
* Eastern Cooperative Oncology Group 0-2
* Measurable or evaluable disease
* Adequate major organ functions

  * Hb ≥ 9.0 g/dL
  * White blood cell count ≥ 3000/μL
  * Absolute Neutrophil Count (ANC) ≥ 1500/μL \[\*ANC = neutrophil segs ＋ neutrophil bands\]
  * Platelet ≥ 100 × 103/ μL
  * Total bilirubin ≤ 1.5 ×UNL, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3.0x UNL(in case of liver metastasis, AST/ALT ≤ 5.0 x UNL)
  * Serum creatinine ≤ 1.5 × UNL (in case of serum creatinine \> 1.5 mg/dL , Ccr should be \>= 50 mL/min, Ccr is calculated by Cockcroft-Gault or 24hr urine collection)
* Life expectancy \> 3month
* Written informed consent

Exclusion Criteria:

* Metastatic or recurrent stomach cancer other than adenocarcinoma
* HER-2 positive
* Clinically significant, uncontrolled gastric outlet obstruction, bleeding, or perforation
* Radiation therapy within the previous 2wks
* Major surgery or trauma within the previous 4wks
* Other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
* Uncontrolled brain metastasis
* Presence of other serious disease (cardiovascular, hepatic, infection etc.)
* Patients who participated in other clinical trials within the previous 30days
* Men of childbearing potential not willing to use effective means of contraception
PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma

Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy

The goal of this project is improved imaging of prostate cancer by positron emission tomography (PET) with use of the radiopharmaceutical C-11 Acetate, utilizing state-of-the-art PET/CT camera technology and processing algorithms.

A successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy. This study is designed to generate data to add to the understanding of the effectiveness of C-11 Acetate, focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy.

The study is designed to expand on the database of C11-Acetate PET imaging in patients with prior definitive therapy for prostate cancer and evidence of biochemical recurrence (post therapy rise in PSA), and to evaluate the relationship between detection on C11-Acetate PET imaging, PSA (Trigger, Velocity and Doubling Time) and FDG PET imaging.

Specific questions to be addressed:

1. What is the yield of current state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease in this patient population?
2. How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET), Sodium F18 PET bone scans and with that of CT?
3. What is the optimal imaging protocol in terms of imaging time after injection?

Eligibility Criteria:
Inclusion Criteria:

* recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)

Exclusion Criteria:

* \< 18 years old
* claustrophobic patients
Tailored Hydration Based on Bioimpedance Analysis for Prevention of Contrast Induced Acute Kidney Injury

The aim of this study was to evaluate, in patients with "normal fluid status" assessed by the bio-impedance analysis, whether two different protocol of IV isotonic saline infusion are associated with different volume expansion and differing risks for Contrast Induced Acute Kidney Injury in patients undergoing coronary angiographic procedure.

Iodinated contrast media are a well-recognized cause of iatrogenic acute kidney injury in patients undergoing imaging diagnostic or therapeutic procedures (contrast-induced acute kidney injury, CI-AKI). Extracellular volume expansion at the time of contrast media administration may represent important protective strategies that play a major role in the prevention CI-AKI.

Bio-impedance analysis is an inexpensive, rapid, and accurate tool for evaluating a patient's hydration status, and can be performed at the bedside within minutes \[Maioli, Journal of American College Cardiology 1014;63:1387-94\]. In this study we defined patients with "lower fluid status" with high risk of CI-AKI (Male with resistance/ height ratio \> 315 Ohm/meter and Female \> 380 Ohm/meter). Bio-impedance analysis IVA may represent the optimal tool to monitor the adequacy of volume expansion and protective strategy delivery.

Infusing a standardized amount of fluid before the procedure may not result in the same effects in all patients. Moreover, standardized fluid infusion for 24 hours in patients that present with "normal fluid status" assessed by the bioimpedance analysis, can represent a too expensive preventive option both in terms of care and discomfort for the patient. In this study we analyze the possibility of a non-inferiority preventive protocol that involves a lower infusion of saline solution with a shorter administration time.

Eligibility Criteria:
Inclusion Criteria:

* consecutive patients admitted in Cardiology Unit for coronary or peripheral angiography with "normal fluid status" assessed on the basis bio-impedance analysis (Male with resistance/height ratio \< 315 Ohm/meter and female \< 380 Ohm/meter)

Exclusion Criteria:

* contrast medium administration within the 10 days
* end stage renal failure requiring dialysis
* no ability to evaluation the state of hydration with bio impedance
* refused to give informed consent