cyrilzakka/clinical-trials huggingface dataset:
iConquerFear Program for the Treatment of Fear of Cancer Recurrence in Patients With Localized Renal Cell Carcinoma

This trial investigates whether an online intervention, iConquerFear, can reduce fear of cancer coming back (recurrence) and anxiety in patients with renal cell carcinoma that is restricted to the site of origin, without evidence of spread (localized). This intervention is an online adaptation of a highly effective face-to-face treatment for fear of recurrence that teaches strategies for: controlling worry and excessive threat monitoring, modifying unhelpful beliefs about worry, developing appropriate monitoring and screening behaviors, addressing cancer-related existential change, promoting values-based goal setting, and reducing uncertainty by providing information about cancer and treatment. The information learned may help others with renal cell carcinoma who also have a fear of cancer recurrence.

PRIMARY OBJECTIVES:

I. To assess feasibility and acceptability of the iConquerFear program for patients with renal cell carcinoma (RCC).

II. To assess preliminary effects of the program on Fear of Cancer Recurrence-7 item scale (FCR-7), Patient-Reported Outcomes Measurement Information System (PROMIS)-anxiety, PROMIS-depression, and Functional Assessment of Chronic Illness Therapy-General (FACT-G).

III. Explore differences in feasibility and efficacy of iConquerFear by sociodemographic or clinical factors.

OUTLINE:

Patients complete 5 sessions of iConquerFear program online over 5 weeks. Patients also complete questionnaires at baseline, after the intervention, and 2 months later.

Eligibility Criteria:
Inclusion Criteria:

* Sufficiently fluent in English
* Cytologically or pathologically verified diagnosis of RCC
* Undergone nephrectomy with negative margins (NOTE: Patients with other local definitive therapies, e.g., radiofrequency ablation or stereotactic ablative radiotherapy \[SABR\], would not be candidates for this protocol)
* No evidence of metastatic disease (including at a minimum computed tomography \[CT\] of the chest, abdomen and pelvis for staging)
* Internet access and basic computer skills
* Moderate to severe fear of cancer recurrence (FCR)
Relation of Obesity With Frequency of Meals (MST 0557)

The purpose of this study is to test the relationship between frequency of meals and hepatic fat content and insulin sensitivity. We, the researchers at Rockefeller University, hypothesize that low plasma insulin levels (as achieved by periods of fasting) will prevent insulin resistance and reduce hepatic lipid content. In contrast, frequent, carbohydrate-rich meals will predispose to hepatic steatosis (non-alcoholic) and insulin resistance.

This is a 6 week inpatient study.

The hypothesis will be tested by studying two groups of normal subjects who will receive a defined weight maintenance diet: one group will be given meals twice a day and other group will be given eight meals (snacks) per day. At the beginning of the study period and after 4 weeks following the specified frequency of meals, the study subjects will have their whole body insulin sensitivity and hepatic fat content measured by the euglycemic-hyperinsulinemic clamp and MRI of the liver, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy individuals
2. Age between 18-45 years
3. Body mass index (BMI) between 18.5 - 24.9

Exclusion Criteria:

1. Diabetes mellitus
2. Chronic drug treatment for any medical condition like hypertension or hyperlipidemia, hyperthyroidism or taking weight control medications.
3. Inability to give informed consent.
4. Inability to give contact information including permanent residence or provide evidence of stable living environment for the study period.
5. Active weight reduction of more than 7 pounds in the last 3 months.
6. History of bleeding or blood clotting disorders.
7. Pregnancy or breast-feeding in the women.
8. History of anaphylaxis or anaphylactoid-like reaction as a result of food allergies.
9. HIV or hepatitis B and C positive subjects.
10. Subjects with hemoglobin \< 8.5 gm/dl.
11. Abnormal liver function test (ALT, AST, alkaline phosphate, LDH, GGT or total bilirubin).
12. Serum creatinine or BUN greater than the upper limit of the normal, serum albumin less than 3.5g/dl, or proteinuria 1+ or greater.
13. History of alcohol intake of more than 40 g/day.
14. Contraindications to magnetic resonance imaging (MRI) including pacemakers, surgical clips, metallic implants, neuromuscular- skeletal stimulators and internal orthopedic screws or rods.
Pharmacokinetics of the Basel Phenotyping Cocktail Combination Capsule

Healthy Subjects will receive treatment orally with 120-200ml tap water in fasted state.

Treatment in period A is the "Basel phenotyping cocktail" capsule. Treatment in period B consists of simultaneous intake of isolated formulations. In both study arms peripheral venous and capillary blood (DBS) samples will be drawn


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years old
* Caucasian male volunteers
* Body mass index (BMI)18-30kg/m2,weight more than 50kg
* Full mental and legal capacity
* Signed informed consent prior to any study related procedure
* Ability to communicate in German or English, sufficient to comprehend and adhere to study protocol
* Systolic blood pressure (SBP) 100-145mmHg, diastolic blood pressure (DBP) 50-90mmHg and heart rate (HR) 45-90bpm (inclusive), measured on the leading arm\*, after 5min in the supine position at screening Normal physical examination, vital signs, laboratory workup, and electrocardiogram (ECG)
* Hematology and clinical chemistry results not deviating from the normal range to a clinically relevant extent at screening
* No other conditions or circumstances that might interfere with compliance with study protocol

Exclusion Criteria:

* Known hypersensitivity to any excipients of the drug formulations.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity.
* History or presence of smoking (within the last 3months prior to screening) or alcohol or drug abuse
* Intake of prescribed or otc medications, herbal preparations, and / or vitamin/dietary supplements within 2weeks prior to the intended start of study.
* Excessive caffeine consumption, defined as \>800 mg per day at Screening Intake of food products (immediately before or during study) known to be inducers or inhibitors of CYP450
Botulinum Toxin Therapy in Hidradenitis Suppurativa

This study will build on data from mice and humans implicating TRPV1 nociceptors in the pathogenesis of the type-17 chronic inflammatory skin disease Hidradenitis Suppurativa (HS). In this study, the investigators will test the hypothesis that inhibiting neuropeptide activity with botulinum toxin reduces pathogenic inflammation.

Botulinum toxin prevents vesicle fusion at nerve terminals thereby inhibiting neuropeptide release. The investigators will collect punch biopsies of lesional skin from HS patients before, and 1-2 months after botulinum toxin treatment (50U per axilla in 10 injections of 0.1mL) then perform flow cytometric, transcriptomic, and microscopic analysis of skin to determine if nonselective inhibition of neuropeptide release diminishes IL-17 driven skin inflammation.

Eligibility Criteria:
Inclusion:

* Adults between ages 18 and 75 years with established diagnosis of hidradenitis suppurativa (HS)
* HS skin lesions of duration at least 1 year, HS skin lesions in at least two different body areas

Exclusion:

* Age \< 18 years or \> 75 years
* pregnant or breastfeeding
* neuromuscular disorder (ex. ALS, myasthenia gravis, Lambert-Eaton syndrome, myopathy)
* medical co-morbidity that is a relative contraindication to skin biopsy procedure (ex. end stage congestive heart failure or coagulopathy)
* active bacterial, fungal, or viral infection in the treatment area
* known hypersensitivity to botulinum toxin A preparations or any of their components (human albumin, saline, lactose, sodium succinate)
* prisoners
* adults unable to consent for themselves.
Internal Versus External Tocodynamometry and Labor Outcome

In this study, parturients will be randomized to either internal or external tocodynamometry contractions' follow up. Investigators recruit primiparous, those who try to have vaginal birth after cesarean section and multiparous, who need oxytocin during labor. Primary endpoint is the number of operative labors in each group. Secondary endpoints are the duration of labor, the use of oxytocin and the condition of the newborn.


Eligibility Criteria:
Inclusion Criteria:

* gestational age ≥ 37 weeks
* singleton pregnancy
* a fetus in cephalic position
* normal cardiotocograph in the time of randomization
* cervical ripening \< 7 cm
* either 1) primipara, 2) multipara, who needs oxytocin during first stage of labor or 3) parturients with previous cesarean section

Exclusion Criteria:

* parturient with hepatitis or HIV or other significant viral infection
* Acute infections (fever over 37,5, or C-reactive protein over 20) in the time of randomization
* Estimated fetal weight over 4,5 kg
* Suspected fetal abnormality
One-4-ALL Initiative

This study aims to improve health outcomes of individuals and populations, enhance the patient experience, reduce the per capita cost of care, and ensure the well-being of our healthcare providers (quadruple aim). These goals are increasingly difficult to achieve, given the challenges of changes to workflow, staffing shortages, and increased costs brought on by the COVID-19 pandemic. Further, the pandemic brought to light the critical need to transform healthcare access for our racially and culturally minoritized and low-income families that have long been victims of health disparities, specifically with poorer health outcomes.

The overall objective is to successfully implement a patient app that will be used by families to 1) increase throughput for all patients, including minoritized, low-income, and low health literacy patients, and 2) reduce administrative burdens on providers.

To evaluate this hypothesis, the following specific aims will be examined:

Aim 1: Document modifiable factors that negatively and positively impact providers' ability to provide high-quality patient care in a post-pandemic healthcare system while addressing health disparities through implementation science.

Aim 2: Create a "boarding pass' experience for providers and patients using technology (app) which allows patients and their families to fully prepare for their clinical visits and bridge care between home, primary care providers, and specialty care.

Aim 3: Investigate multilevel contextual factors related to app implementation, to inform future strategies to promote scalability and sustainability of app in all specialties.

Eligibility Criteria:
Inclusion Criteria:

* All guardians of patients and the providers (surgeons, doctors, nurses, etc) that serve these patients.

Exclusion Criteria:

* None.
Feeding Readiness and Oral Feeding Success in Preterm Infants

To examine the effects of sensorimotor interventions applied to in preterm infants on readiness for feeding and oral feeding success.

The preterm neonate population cannot potentially be fed orally for a long time in the postnatal period. However, the inability of preterm infants to be fed orally as soon as they are born is not a disease, their adaptation to the external environment of the uterus is more complicated because their physiological functions are not yet mature. This also means long hospital stays for premature babies. Therefore, the American Academy of Pediatrics (AAP) has determined that oral feeding is one of the main criteria for the discharge of the preterm infant from the hospital.

Many studies have been conducted on preterm infants on optimizing oral feeding performance. Studies improve oral feeding skills of preterm infants by applying various sensorimotor interventions and cue-based feeding protocols to improve oral feeding performance. These sensorimotor interventions; non-nutritive sucking (pacifier), sucking-swallowing exercises, oral support, oral stimulation, tactile stimulation, kinesthetic stimulation, sound, smell, audio-visual stimulations, etc. methods were used alone or in combination with these methods.

It has been shown in studies that sensorimotor interventions increase the success of oral feeding in preterms, increase the daily feeding volume, increase weight gain, reduce the cost by shortening the hospital stay, shorten the transition time from gastric feeding to oral/breastfeeding and help mother-infant bonding.

This thesis study was conducted using evidence-based interventions that can facilitate the development of oral feeding skills in preterm infants, the feeding problems they encounter, and their transition from gastric feeding to oral feeding.

Eligibility Criteria:
Inclusion Criteria:

* The mother's milk
* Preterm babies with a gestational age of 30-33 weeks
* No facial deformity,
* No respiratory, cardiovascular, gastrointestinal and neurological disorders or syndromes that would prevent or complicate oral feeding,
* No need for oxygen support,
* There will be preterm infants who are not fed orally, but who are started with tube (Orogastric) feeding.

Exclusion Criteria:

* Transferred to another center during the research,
* Unexpected complication development during the research,
* Occurrence of a pathology that will prevent or complicate oral feeding,
* In cases where there is no voluntary consent of the parent
* The mother is Covid positive
The Effect of Stellate Ganglion Block on Insomnia Patients

A prospective study was conducted on Insomnia Patients. All the patients were provided with Stellate Ganglion Block. The quality of sleep was evaluated to see if Stellate Ganglion Block can improve Insomnia.

Insomnia is a sleep disorder characterized by difficulty falling asleep, staying asleep, or experiencing non-restorative sleep, despite having adequate opportunity for sleep. It is a common condition that can significantly impact an individual's quality of life and overall well-being.A prospective study was conducted on Insomnia Patients. All the patients were provided with Stellate Ganglion Block. The quality of sleep was evaluated to see if Stellate Ganglion Block can improve Insomnia.

Eligibility Criteria:
Inclusion Criteria:

* Insomnia patients with the ages over 18.
* Meeting the diagnostic criteria for chronic insomnia as per the International Classification of Sleep Disorders (ICSD) or the Diagnostic and Statistical Manual of Mental Disorders (DSM).
* Experiencing insomnia symptoms persistently for at least three months.
* Not currently using or ceased using medication for insomnia for at least four weeks.
* Willing to undergo Stellate Ganglion Block treatment and participate in the study.

Exclusion Criteria:

* Patients with severe cardiovascular disease, pulmonary disease, or other serious physical health issues.
* Pregnant or lactating women.
* Patients with mental disorders (such as major depression, anxiety disorders, schizophrenia, etc.) or cognitive impairments.
* Patients with known allergies or contraindications to Stellate Ganglion Block treatment.
* Patients currently participating in other clinical trials or receiving experimental treatments.
Women Engaging in Quitting Smoking Together

The long-term goal of this program of research is to develop and disseminate an efficacious, group-based distress tolerance treatment for weight concern (DT-W) that will significantly increase smoking cessation rates among women. The objective of this project is to conduct a preliminary randomized controlled trial (RCT) (N = 60) comparing DT-W to a Health Education (HE) comparison intervention, in which both groups also receive standard behavioral smoking cessation treatment (ST) including counseling and transdermal nicotine patch (TNP), and examine potential mechanisms that may underlie the efficacy of DT-W in improving smoking outcomes at 1-, 3-, and 6-month follow-ups.


Eligibility Criteria:
Inclusion Criteria:

female

* at least 18 years of age
* smoke 5 or more cigarettes per day
* daily smoker for at least the past year
* report motivation to quit smoking in the next month of at least 5 on a 10 point scale
* report concern of at least 50 on at least one of two 100 point scales assessing weight concern
* able to travel to study location for study appointments

Exclusion Criteria:

* current use of other smoking cessation or weight loss therapies
* current use of other tobacco products at least weekly
* diagnosis or treatment for non-nicotine substance use disorder with substance use during the past 6 months
* lifetime diagnosis or treatment of eating disorder, bipolar disorder, schizophrenia, or schizoaffective disorder
* score above established cut-offs on self-report screening measures of depressive symptomology, eating disorder symptomology, alcohol use disorder, or drug use disorder
* current suicidality or homicidality
* medical condition that is a contraindication for the use of transdermal nicotine patch
* lives at same address as current or past participant
Postoperative Cognitive Dysfunction After Total Knee or Hip Replacement Surgery in Fast-track Set-up

The aim of this study is to quantify the incidence of postoperative cognitive dysfunction in the elderly patient (\>60y) after total hip or knee replacement surgery. The hypothesis is that the fast-track methodology with a mean hospital stay less than 3 days will help to minimize this reduction in memory and concentration.


Eligibility Criteria:
Inclusion Criteria:

* 60 years of age or above
* ASA classification 1-4
* undergoing fast-track hip or knee replacement

Exclusion Criteria:

* anaesthesia within the past 90 days
* daily consumption of sleep or anxiety medication
* more than 35 units of alcohol per week
* lack of proper verbal and reading skills, Danish
* Serious hearing or visual impairment
* Mini mental status evaluation (MMSE) \< 24
* Parkinsons Disease or other neurological disease causing functional impairment
A Livelihood Intervention for Impoverished Women in Rural Uganda

The objective of the study is to determine whether a livelihood intervention can improve economic and psychosocial wellbeing in rural Uganda.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-60 years (or emancipated minors aged 16-17 years) who live with at least one child under the age of 5 in the same household
* Women aged 18-60 years (or emancipated minors aged 16-17 years) who agree to participate in the livelihood intervention training program
* Women aged 18-60 years (or emancipated minors aged 16-17 years) who agree to participate in study data collection

Exclusion Criteria:

* Men
* Women who do not live in Nyakabare Parish
* Women under 18 years of age (if not emancipated minors) or older than 60 years of age
* Women who do not live with at least one child under the age of 5 in the same household
* Women who decline to participate in the livelihood intervention training program
* Women who decline to participate in study data collection
* Women who live in the same household as another study participant
Formoterol Certihaler, Tiotropium HandiHaler and Tiotropium HandiHaler in Combination With Formoterol Certihaler in Patients With Stable Chronic Obstructive Pulmonary Disease

This study is not being conducted in the United States.

This study is designed to provide efficacy and safety data for formoterol 10µg twice-a-day (b.i.d.) delivered by the Certihaler in patients with chronic obstructive pulmonary disease (COPD). This study is also designed to compare the efficacy and safety of therapy with formoterol (Certihaler)10µg b.i.d. added to tiotropium (HandiHaler) 18µg once daily (o.d.) compared with tiotropium (HandiHaler) 18µg o.d. monotherapy, and to compare the safety and efficacy of formoterol 10µg b.i.d. (Certihaler) with tiotropium 18µg o.d. (HandiHaler).


Eligibility Criteria:
Inclusion Criteria:

* Co-operative males or females with a diagnosis of moderate COPD as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria with an age at onset ≥ 40 years.
* Current or previous smokers with a smoking history of ≥ 10 pack-years. Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.
* Pre-bronchodilator forced expiratory volume in one second (FEV1) \< 70% of patient's predicted normal value and ≥ 1.00 L, with FEV1/forced vital capacity (FVC) \< 70% at Visit 2.
* A total symptom score from the patient diary of more than 0 on at least 4 of the last 7 days prior to Visit 3

Exclusion Criteria:

* Pregnant women, nursing mothers, and females of childbearing potential, regardless of whether or not sexually active, who do not use a reliable contraceptive method (oral, mechanical, subcutaneous or surgical contraception).
* Patients who have been hospitalized for an acute exacerbation of their airway diseases in the month prior to Visit 1 or during screening.
* Patients who have had a respiratory tract infection within 1 month prior to Visit 1. Patients who develop a respiratory tract infection during the screening period must discontinue from the trial, but will be permitted to re-enroll at a later date (at least 1 month after the resolution of the respiratory tract infection).
* Patients with concomitant pulmonary disease including a history of cancer (all), pulmonary tuberculosis or congenital bronchiectasis.
* History of asthma
Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment

This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition. The Investigators know that older boys and men with Klinefelter syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but we do not know if this difference is present at birth or develops over time. The Investigators will learn if body composition and motor skills are improved with testosterone treatment in infants with Klinefelter syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Male infants with 47,XXY karyotype

Exclusion Criteria:

* Gestational age at birth \<36 weeks
* Birth weight \<5%ile or \>95% for gestational age
* History of thrombosis in a first degree relative
* Exposure to androgen therapy outside of the study protocol.
The Effects of Bimanual Laryngoscopy on Post-Operative Sore Throat in Adults

Post-operative sore throat, cough, and hoarseness of voice are common, uncomfortable, distressing sequelae after tracheal intubation. It was postulated that these effects are because of irritation and inflammation of the airway. Bimanual laryngoscopy is known to improve visual field during intubation. This procedure might reduce laryngeal trauma during intubation and therefore reduce the incidence or degree of post-operative sore throat. This is the first prospective, double-blinded, controlled study, which is focused on the effects of bimanual laryngoscopy on first 24-houred post-operative sore throat (POST).


Eligibility Criteria:
Inclusion Criteria:

1. ASA I or II
2. 20-70 y/o
3. GAET for A. Breast op B. GYN op C. Upper/lower extremities op D. Ophthalmology op E. GU op F. minor surgery

Exclusion Criteria:

1. emergency surgery
2. head and neck surgery
3. recent URI symptom in last one weeks with medication
4. post op PCA use
5. on NG/OG
6. perioperative bucking