cyrilzakka/clinical-trials huggingface dataset:
Characteristics of Adult Patients With Recessive Dystrophic Epidermolysis Bullosa

Recessive dystrophic epidermolysis bullosa (RDEB) is a severe inherited blistering disease caused by the absence of type VII collagen. Patients with RDEB develop large, severely painful blisters and open wounds from minor trauma to their skin. We are screening RDEB subjects to determine additional characteristics of patients who survive to adulthood.


Eligibility Criteria:
Inclusion Criteria:1. Clinical diagnosis of RDEB by local dermatologist. 2. 18 years of age or more and willing to give consent. Exclusion Criteria:1. Medical instability limiting ability to travel to Stanford University Medical Center.
Immunogenicity and Safety of Concomitant Administration of RotaTeq™ (V260) and the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) in Healthy Japanese Infants (V260-060)

The study will evaluate the immunogenicity of the Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP-IPV) with concomitant administration of RotaTeq™ (V260) in healthy Japanese infants. The hypothesis to be tested is that the antibody response rates to DTP-IPV with concomitant administration of RotaTeq™ are non-inferior to those with staggered administration of RotaTeq™.


Eligibility Criteria:
Inclusion Criteria:

* Japanese participant
* Age 6 weeks through \<11 weeks (42 to 76 days from date of birth) at Visit 1

Exclusion Criteria:

* History of hypersensitivity and/or anaphylaxis to any of the product ingredients in V260 or DTP-IPV
* Gastrointestinal disorder, growth retardation, or failure to thrive
* History of intussusception
* Untreated congenital gastrointestinal disorder (such as Meckel diverticulum)
* Known or suspected impairment of immunological function, including severe immunodeficiency (SCID)
* Cardiovascular, renal, liver, or blood disease
* History of convulsion
* Undergoing immunosuppressive therapy or living with a close relative with congenital immune deficiency
* Prior vaccination with rotavirus vaccine and/or DTP-IPV vaccine
* Live vaccine received within 28 days or inactivated vaccine received within 7 days
* At high risk for tuberculosis exposure
Exercise and Diet Counseling Program in Improving Quality of Life in Stage I-III Breast Cancer Survivors

This trial studies the benefits of an exercise and diet counseling program in improving quality of life in stage I-III breast cancer survivors. Exercise and diet counseling may help improve weight loss and relevant clinical and patient-reported outcomes in overweight or obese breast cancer survivors.

PRIMARY OBJECTIVES:

I. To determine the feasibility of delivering a community-based, comprehensive lifestyle weight management (LWM) intervention to 20 overweight or obese breast cancer (BC) survivors.

II. Explore preliminary efficacy of the community-based, comprehensive LWM intervention for producing meaningful improvements in select clinically-relevant anthropometric, fitness, functional, and patient-reported outcomes in BC survivors.

III. Provide the effect size estimates necessary to inform the design of a subsequent R01 application addressing a large scale, optimally powered, randomized controlled, community-based LWM comparative efficacy intervention trial targeting weight loss in BC survivors.

OUTLINE:

Patients undergo aerobic exercise over 10-30 minutes and resistance exercise comprising 1-3 sets of 8-12 repetitions of 10 different exercises over 1 hour for 24 weeks. Patients also receive behavioral activity counseling once a week and nutritional counseling over 30 minutes for 10 sessions after center-based exercise sessions during months 1-2.

After completion of study, patients are followed up at 3 and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer (stage I-III), within (w/in) 60 months after cessation of active treatment (surgery, chemotherapy, radiation), and may be on continued hormone therapy.
* Overweight/obese (body mass index \[BMI\] \> 25).
* Ability to understand and the willingness to sign a written informed consent.
* Willing and physically able to participate in physical activity.
* Obtain physician consent via primary care physician and/or treating oncologist.

Exclusion Criteria:

* \> 60 months post breast cancer therapy.
* Contraindications to exercise.
* Diagnosis of cancer other than breast that is receiving active treatment.
* Currently receiving chemotherapy/radiation.
* Musculoskeletal/neurological disorder inhibiting them from safe exercise.
* Pregnant or nursing women.
* Unable to give informed consent.
Thyroid Autoimmunity and Reproductive Failure in Danish Women

The present Ph.D.-study investigates the mechanisms behind the association between thyroid autoimmunity and reproductive failure.


Eligibility Criteria:
Inclusion Criteria:

* Women followed in the Fertility Clinic

Exclusion Criteria:

* Pregnancy at time of blood sampling. Immune-suppressive ⁄modulatory treatments. Women referred for oocyt donation, genetic testing, and hepatitis and HIV-positivity
Negative-pressure Wound Therapy on Full-thickness Skin Grafts of the Lower Leg

This randomized controlled non-sponsored trial on 60 patients evaluates if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications for skin-cancer surgeries below the knee.

Annually, 12 000 skin cancers are diagnosed in Finland. This randomized controlled non-sponsored trial evaluate if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications. 60 patients over 18 years of age are included and randomly assigned to either the negative pressure-treatment group or the conventional treatment group. At the control appointment one-week postsurgery, graft take is documented as a primary outcome and any complications (necrosis, infection, hematoma/seroma) and adverse events (pain, skin reactions) as secondary outcomes. Adverse events are evaluated by a phone call 3 weeks postsurgery and based on medical records 3 months postsurgery.

Eligibility Criteria:
Inclusion Criteria:

* from referrals received by the Unit, or from patients undergoing follow-up who have skin cancer (basal cell carcinoma, squamous cell carcinoma or melanoma) or suspected skin cancer below the knee

Exclusion Criteria:

* Toe lesion, bleeding disorder, severe dementia, critical peripheralischemia, or skin disease that is expected to impair wound healing, such as pyoderma gangrenosum
Adherence to Medical Treatments for Telemedicine Patients

This study will test the feasibility of MedRem, a novel medication reminder and tracking system on wearable wrist devices, specifically with the Apple Watch 4. The study team will load the MedRem app onto two Apple Watch 4s for use during the study. As the device is placed on the wrist, it is free from the limitations of smartphones. However, one of the major challenges in developing interactive systems for wrist devices is their form factor. The touch screens available on these devices are tiny and much smaller compared to smart phones and tablet computers. MedRem enables user interactions by incorporating speech recognition and text-to-speech features along with clever interface design. The tiny display of the device is used for minimal inputs and outputs, while a user can retrieve and provide more information from/to the system through voice commands. Personalized models are built and updated over time to reduce errors in recognizing users' voice commands, and thus better user experience is provided.


Eligibility Criteria:
Inclusion Criteria:

* Phase 1 (Controls)

  * 18 - 75 years old
  * Good general health (self-reported), with no history of cerebral vascular accident (CVA)
  * English-speaking
  * Willingness and ability to comply with scheduled visits and study procedures

Phase 2 (Stroke Patients)

* 18 - 75 years old
* English-speaking
* Willingness and ability to comply with scheduled visits and study procedures
* Have requirements for home- based therapy regimens (i.e. physical/occupational therapy)
* Require medications for secondary stroke prevention (e.g. antithrombotic therapy to prevent ischemic stroke, stroke risk factor management with blood pressure, diabetes, cholesterol medications).
* Have a Modified Rankin Scale for Neurologic Disability (MDS) of 2 - 4

Exclusion Criteria:

* Phase 1 (Controls)

  * Pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, non-English speaking subjects
  * Prohibitive cognitive impairments or language deficits
  * Does not have wireless internet connection at home

Phase 2 (Stroke Patients)

* Pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, non-English speaking subjects
* Have a Modified Rankin Scale for Neurologic Disability (MDS) of 0-1 or 5
* Prohibitive cognitive impairments or language deficits
* Significant weakness, dystonia, or spasticity that will prevent proper use and response to the Apple Watch device
* Live in nursing home or rehabilitation facility
* Does not have wireless internet connection at home
Bonding Quality and Gene Expression in Fullterm Infants Compared to Late Preterm Infants and Preterm Infants With Early Skin to Skin or Visual Contact

Recent research has identified differences in the quality of mother-child interaction and gene expression of six key molecules involved in stress response and neurobehavioral development in preterm infants (born \<32 weeks of gestational age) with early skin to skin contact after birth compared to infants with visual contact at six months corrected age. We hypothesize that these differences are still identifiable at the age of 6 to 8 years and that quality of bonding in preterm infants born \<32 weeks of gestation differs significantly from late preterm infants and full-term infants.

Quality of bonding in former preterm infants born 2012 to 2015 who participated in the "delivery room skin to skin study" (deisy), moderate to late preterm infants born 2010 to 2011 who participated in the "trauma and depression in late preterm parents study" (TraDelPP) and full-term infants at 6 to 8 years of age is assessed using the German version of the attachment story completion task (ASCT). Additionally, gene expression of six key molecules involved in stress response and neurobehavioral development (the corticotropin releasing hormone receptor 1 and 2 genes (CRHR1 and CRHR2), arginine vasopressin gene (AVP), the glucocorticoid receptor gene (NR3C1), the serotonin receptor 2A gene (HTR2A), and the serotonin transporter gene (SLC6A4)) are quantified in in mucosal epithelial cells from buccal swabs of children of all four groups. Maternal and infant co-factors such as maternal depression, perceived social support, parental stress, infant health development and behavior are assessed by self-reporting questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* first child, singleton, former participant of "deisy" or "TraDelPP" study for preterm infants, uncomplicated vaginal birth for fullterm infants

Exclusion Criteria:

* Maternal mental health problems, resuscitation after birth, malformations or severe underlying disease
A Study to Evaluate the PK, PD and Safety of CKD-382 in Healthy Subjects

to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

A randomized, open-label, crossover phase 1 clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety after single/multiple administration of CKD-382, D860 and D027 in healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* Between 19 aged and 50 aged in healthy adult
* Body weight more than 50kg
* BMI more than 18.0 and under 27.0
* Who has negative result on Helicobacter Pylori antibody test

Exclusion Criteria:

* Have clinically significant disease that hepatobiliary system, kidney, nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system or mental illness, or a history of mental disease
* Have a gastrointestinal disease history(including surgery) that can effect drug absorption
* Hypersensitivity reaction of clinically significant hypersensitivity reaction in the history of Esomeprazole, additives or benzimidazole family
TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients

Hematopoietic stem cell transplant (HSCT) is an effective but toxic therapy and pulmonary morbidity affects as many as 25% of children receiving transplant. Early pulmonary injury includes diffuse alveolar hemorrhage (DAH), thrombotic microangiopathy (TMA) interstitial pneumonitis (IPS) and infection, while later, bronchiolitis obliterans is a complication of chronic GVHD associated with severe morbidity and mortality. Improved diagnosis and treatment of pulmonary complications are urgently needed as survival after HSCT improves, and as HSCT is increasingly used for non-malignant disorders such as sickle cell disease. Currently, there are large and important gaps in the investigator's knowledge regarding incidence, etiology and optimal treatment of pulmonary complications. Moreover, young children unable to perform spirometry are often diagnosed late, and strategies for monitoring therapeutic response are limited.

This is a prospective multi-institutional cohort study in pediatric patients undergoing allogeneic hematopoietic stem cell transplantation (alloHSCT). Assembly of a large prospective uniformly screened cohort of children receiving HSCT, together with collection of biological samples, will be an effective strategy to identify mechanisms of lung injury, test novel diagnostic strategies for earlier diagnosis, and novel treatments to reduce morbidity and mortality from lung injury after transplant.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≤ 24 years of age undergoing allogeneic or autologous HSCT.

Exclusion Criteria:

* Subjects over 24 years of age.
The Comparative Study of Full-Endoscopic Cervical Posterior Discectomy and Anterior Cervical Decompression and Fusion

Anterior cervical decompression and fusion is the standard procedure for operation of cervical disc herniations. Mobility-preserving Full-Endoscopic Cervical Posterior discectomy is the most common alternative in the case of soft localization of the pathology. Endoscopic techniques are considered standard in many areas, since they may offer advantages in surgical technique and rehabilitation. These days, all disc herniations can be operated in full-endoscopic technique. With the full-endoscopic posterior cervical discectomy a procedures is available for cervical disc operations.

Investigators conducted a differential, randomized, 1:1, double-blind clinical control trial to compare the clinical effect, safety and feasibility of Full-Endoscopic Cervical Posterior discectomy and Anterior cervical decompression and fusion. The study was conducted in three centers at the same time, including the Second Affiliated Hospital of Zhejiang University Medical College, Zhejiang Provincial People's Hospital and Ningbo University Medical College Affiliated Hospital. This study is expected to include 308 patients with single level soft cervical disc herniation.Participants were randomly assigned to different groups for corresponding surgical intervention after complete preoperative evaluation.Participants received a standard 5-year follow-up procedure

Eligibility Criteria:
Inclusion Criteria:

1. Single cervical intervertebral dis herniation wih symptoms of radicular pain or spinal cord compression ; 2) the herniated lesions had no obvious calcification; 3) conservative treatment fails ; 4) mild myelopathy (Nurick grade 3 or blow. (6) patients agree to participate in this study.

Exclusion Criteria:

1. cervical segmental instability or deformity (cervical spondylolisthesis or Cobb Angle greater than 25°); 2) multisegmental lesions (≥2); 3) tumor, infection or other unknown space occupying in cervical vertebra; 4) surgical history of the target segment; 5) severe myelopathy (Nurick grade 4 or above); 6) the patients were not suitable for surgery, had poor medical management or did not agree to participate in this study.
Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder

The main purpose of this study is to determine how safe and effective Gabitril is for outpatients with Social Anxiety Disorder (SAD).

This study is being conducted at two sites in the United States. Approximately 50 patients, who are between the ages of 18 and 65 years old will be enrolled at Emory. This study consists of two parts. The first part consists of 12 weeks of open-label treatment with Gabitril. If the study doctor determines that the patients condition has improved and they have completed the initial 12 weeks of treatment they may be eligible for the second part of the study. This part is a 24-week double-blind treatment period with either Gabitril or placebo (inactive medication). There will also be a follow-up visit about 1 to 3 weeks after they have completed taking the study medication. Altogether study participation is expected to last approximately 37 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of SAD
* CGI (S) ≥ 4 at screen
* LSAS ≥ 50 at baseline
* Covi Anxiety Scale score greater than the Raskin depression Scale total score at screen

Exclusion Criteria:

* Non-responsive to adequate trials of two or more treatment medications, if previously treated for SAD.
* HAM-D ≥15 or a score of \>2 on Item 1 at baseline
* Serious or unstable medical condition
* Alcohol or substance use disorder within 6 months prior to study
A 24-week rPMS Study in Real-world Setting for Enerzair

This surveillance was designed as a prospective, open-label, multicenter, single-arm, non-interventional, observational study to evaluate the safety and effectiveness of Enerzair inhalation capsule for up to 24 weeks under routine clinical practice.

The two different doses of Enerzair inhalation capsule via Breezhaler will be prescribed according to the approved label information in Korea, and the investigation for any additional diagnostic or monitoring will be not conducted for this study.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients (≥18 years of age) with a physician's diagnosis of asthma, who are prescribed Enerzair inhalation capsule (indacaterol acetate/ glycopyrronium bromide/mometasone furoate; 150/50/80, 150/50/160 μg) via Breezhaler, as per the approved label information
2. Patients who participate in the study after signing the consent form for data collection and use (Data Privacy ICF) after receiving a clear explanation of the objectives and nature of the study from the investigator

Exclusion Criteria:

1. Patients who are contraindicated for this medicinal product as described in the Precautions for Use in the label information (package insert) A. Patients with hypersensitivity reaction to this medicinal product or any of its constituents B. Because this medicinal product contains lactose, patients with hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption, etc.
2. Patients with acute asthma symptoms, including acute episodes of bronchospasm, for which a short-acting bronchodilator is required
3. Patients participating in other interventional clinical trials
TwySHE - An Mhealth Peer-navigator Intervention to Increase PrEP and Contraceptive Use

The goal of this clinical trial is to learn if the TwySHE intervention can increase the use of HIV prevention in at-risk female university students aged 18-24 in Zambia. The main question it aims to answer is:

• Can a mhealth peer navigator intervention effectively promote HIV pre-exposure prophylaxis PrEP use among high-risk female students in Zambia?

Researchers will compare the mhealth peer navigator intervention to treatment as usual to see if there are effects on female student's use and continuation of PrEP for HIV prevention.

Participants in the intervention will be paired with a trained peer navigator who will offer education, social support, and help navigating the health systems to access PrEP and other sexual and reproductive health services.

All participants in both arms will complete surveys at baseline, 6 months, and 12 months to evaluate health behaviors.

We are conducting a 1:1 individual-randomized, open-label single-site hybrid type 1 effectiveness-implementation trial to determine the effectiveness the TwySHE intervention in Lusaka, Zambia. We will follow all participants for 12 months with regular data collection. All intervention activities will end at 6 months (primary endpoint window), but we will continue to follow and survey participants in both study arms at 12 months to determine long-term post-intervention effectiveness. PrEP and contraception uptake and persistence will be objectively verified using a study medical visit card filled out and signed by health providers. We will also collect and assess behavioral mechanisms hypothesized to be on the casual pathway, including participant knowledge regarding HIV and unintended pregnancy prevention, health beliefs (perceived risk of HIV or unintended pregnancy), perceived social support to access and adhere to HIV/unintended pregnancy prevention methods, stigma, behavioral intention to use PrEP and contraception, and self-efficacy to use PrEP and contraception. Lastly, we will conduct exit interviews with peer-navigators and a sub-sample of participants to explore the implementation outcomes of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 to 24 years
* Current university student
* Not diagnosed with HIV
* Self-report of 3 more HIV risk factors

Exclusion Criteria:

* Male
* Less than 18 years of age
* Greater than 24 years of age
* Diagnosed with HIV
* Less than 3 self-reported HIV risk behaviors
* Not a university student
Lindera Obtusiloba for Non-small Cell Lung Cancer

This randomized, open labelled, non-treatment-controlled study evaluates the safety and efficacy of Lindera obtusiloba, a dietary food, on quality of life of non-small cell lung cancer patients who are receiving PD-1 or PD-L1 inhibitors.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥ 20 years
* Patients who have understood and signed the informed consent.
* Subjects who have been confirmed histologically and radiologically for non small cell lung cancer and are scheduled to receive treatment with immune checkpoint inhibitors
* Subjects whose urine HCG are negative and who have agreed with the appropriate method of contraception in case of women of childbearing potential
* Subjects who can fully communicate with their medical doctor about their symptoms or quality of life and who can fill out questionnaires
* Subjects who can follow up during the clinical trial
* Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2
* Hemoglobin ≥ 9g/dL

Exclusion Criteria:

* Subjects who are pregnant, breastfeeding, planning to become pregnant or women of childbearing potential who do not agree with the appropriate method of contraception
* Subjects who have symptomatic and uncontrolled brain or central nervous system metastasis
* Subjects who complain of uncontrolled pain despite using analgesics
* Diastolic Blood Pressure\>100mmHg or Systolic Blood Pressure\>160mmHg
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels higher than 2.5 times the upper limit for normal
* Creatinine level higher than 1.5 times the upper limit for normal
* Subjects who have participated in other clinical trials within 1 months
* Subjects with a history of serious drug allergies or who have hypersensitivity to the Investigational Product (the main ingredient and its components)
* Subjects with autoimmune diseases
* Subjects who have alcoholism or drug dependence
* Subjects who have cognitive impairment or psychiatric problems
* Subjects who have undergone surgery within 2 weeks
* Subjects who took other herbal medicine or other medicines within 4 weeks
* Subjects who have a medical condition that is likely to affect results or who are determined to be inappropriate to participate in this clinical trial at the investigator