cyrilzakka/clinical-trials huggingface dataset:
Observational, Non-Interventional Study Supporting Validation of VO2Max Estimation Methods Using Results in Patients Receiving Standard of Care Cardiopulmonary Exercise Tests (CPET)

In this study, the hypothesis being explored is that VO2Max and other CPET parameters can be accurately estimated from biosignals (namely, motion from accelerometers and cardiopulmonary variables from EKG) collected during activities of daily living using wearable biosensors worn by study participants. This study will aim to collect development and validation data for a machine learning algorithm and to evaluate the performance of the algorithm. A total of 300 participants will be enrolled including: (Normal) 200 participants, self-reported healthy male and female participants aged 18 to 80 and (Standard of Care) 100 participants


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to comply with protocol procedures and available for the duration of the study.
2. Willing to sign and date informed consent document for study participation.
3. Participant is undergoing the Cardiopulmonary Exercise Test (CPET) as Standard of Care

Exclusion Criteria:

1. Participant is pregnant, lactating or ≤30 days post-partum.
2. Any cognitive or physical limitations that, in the opinion of the investigator, limits the participant's ability to fully follow study procedures
Effectiveness of Different Exercise Programmes in Individuals With Dynamic Knee Valgus

Dynamic knee valgus (DDV) is an erroneous movement pattern of the lower limb that occurs in multiple planes. It results from a combination of hip joint adduction, femoral anteversion, knee abduction and external tibial torsion .

Dynamic knee valgus (DDV) is an erroneous movement pattern of the lower limb that occurs in multiple planes. It results from a combination of hip joint adduction, femoral anteversion, knee abduction and external tibial torsion . DDV is also referred to as a mechanism in which the knee joint moves medially relative to the hip and foot with the centre fixed to the ground.

Eligibility Criteria:
Inclusion criteria:

* Age between 18-50 years.
* Absence of any lower extremity pain.
* Having a frontal plane projection angle of 10 and above in the descent phase of squatting on one leg.
* Having active or regular physical activity.
* Volunteering to participate in the study.

Exclusion criteria:

* Active knee pain.
* History of patellar instability.
* Presence of rheumatic diseases such as osteoarthritis, rheumatoid arthritis.
* History of trauma or injury causing ligament laxity in the ankle, hip or knee.
* Having a neurological disease that may impair the ability to perform any lower limb movement.
* Having undergone any lower extremity surgery before.
* Having received physiotherapy from hip, knee and ankle in the last 6 months.
* To be benefiting from another treatment during the study.
Tumor Relapsed Study of Serum Trxr Activity in Advanced Non-small Cell Lung Cancer

In pre-clinical study we found that the thioredoxin reductase activity of serum harbours huge difference between cancer patients and non-cancer patients, the enzyme activity elevated remarkably among cancer patients, and after any kind of treatment serum thioredoxin reductase activity declined remarkably, so we hypothesis that serum thioredoxin reductase activity could be a warning marker for early progression of first-line treatment for advanced non-small cell lung cancer

This is a cooperative research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University, and the State Key Laboratory for Natural Medicine and Biomimetic Drugs Perking University. The primary objective is to measure the thioredoxin reductase activity using blood in subjects received platinum based chemotherapy, to study the warning progression ability of thioredoxin reductase in blood. The secondary objective is to compare the warning progression activity of blood thioredoxin reductase reductase activity with carcinoembryonic antigen in subjects received platinum based first-line chemotherapy. Blood will be collected before chemotherapy, after every 2 cycles of chemotherapy, every 3 months after all first-line chemotherapy till 2 years, then every 6 months till 3 years, or collect blood till tumor progression, evaluation CT results every time collecting blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven non-small cell lung cancer, stage Ⅳ patients or unsuitable for local treatment of ⅢB stage patients
* Malignant tumor treatment naive including surgery（except for surgery for cervical cancer and cutaneous squamous cell carcinoma 5 years before, except for lung cancer patients who received surgery and adjuvant chemotherapy after 12 month then diagnosed with stage ⅢB or Ⅳ）
* Signed informed consent would like to provide blood for research

Exclusion Criteria:

* Patients received antitumor treatment before
* Patients with contraindication of chemotherapy
* Pregnant or breast feeding women
Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer

The investigators are interested in understanding how the patient has been doing since their surgery for endometrial cancer and if they are experiencing any symptoms related to lymphedema (swelling) in the your lower body. The investigators hope that information from the patient and others will help them improve care for women treated for endometrial cancer.


Eligibility Criteria:
Inclusion Criteria:

* Presented to MSK with newly diagnosed endometrial carcinoma of any histologic profile clinically confined to the uterus and/or uterine cervix
* Underwent primary surgery at our institution, to include at least a total hysterectomy via laparotomy, laparoscopy, or robotic approach, between January 2006 and December 2013
* Alive at the time of study activation

Exclusion Criteria:

* Had documented macroscopic evidence of extrauterine disease at the time of initial diagnosis
The GoodNEWS Lifestyle Enhancement Program

This study will train Lay Health Promoters (LHPs) from African-American churches to administer healthy living lessons and activities to their congregations in order to improve overall health and address cardiovascular disease. The primary hypothesis is that LHP training combined with a well supported maintenance strategy will be more effective than LHP training alone in reducing risk factors for cardiovascular disease.

The GoodNEWS Trial is an 18-month effectiveness trial with an 18-month extended maintenance study, among 20 African-American and low-income congregations participating in the GoodNEWS faith-based lay health promotion program. After training, congregations will be randomized to either GoodNEWS with a health maintenance intervention (GoodNEWS-I) or GoodNEWS program alone (GoodNEWS-PA). The maintenance intervention combines elements of the medical care model and features of community-based support. Primary data collection will occur at baseline, 18, and 36 months with the two primary outcomes being levels of physical activity as measured by 7- Day Physical Activity Recall (PAR) and dietary change as measured by the Diet History Questionnaire (DHQ). The primary hypothesis is that the maintenance group will significantly increase physical activity and healthy eating behavior compared to the program only group. We also hypothesize that lipoprotein and glucose levels, and blood pressure will be significantly improved over baseline in the GoodNEWS-I group and that these changes will be significantly greater than in the GoodNEWS-PA group. At the end of the trial, both groups will continue in an 18-month extended maintenance study.

Eligibility Criteria:
Inclusion Criteria:

* Member of selected church congregations in the predominantly African-American geographical area of Dallas, Texas, known as South Dallas or the Southern Sector.
* Between the ages of 18 -70 years

Exclusion Criteria:

* Anyone under the age of 18
* Anyone who is not an active member of one of the participating churches
Clinical Outcomes of the Implementation of Diurnal IOP Curve to 1500 Patients - A Cohort Study.

To present the clinical outcomes of diurnal IOP monitoring and determine its value in our clinical practice.We reviewed the records of 1500 patients (glaucoma suspects or glaucoma patients), who were admitted for diurnal curve during almost 12 years.

We reviewed the records of 1500 patients, who were admitted for diurnal curve during almost 12 years. All patients were hospitalized because their within office-hours exams were considered inadequate and inconclusive for decision-making

744 patients needed change of treatment. 121 patients were programmed for interventional therapy (laser or surgery). 68 patients were declassified, as overdiagnosed and overtreated. In 250 patients hidden adherence problem revealed. In 720 patients peak IOP occurred out of office hours.

Eligibility Criteria:
Inclusion Criteria: IOP diurnal curve consisted of glaucoma patients with intraocular pressure higher than target pressure despite referred previously sufficient therapy and also patients with equal or lower than target pressure, but with disease progression. There were also included patients with advanced glaucoma with visual field defects on the visual field testing, as well as patients with normal tension glaucoma and labile secondary glaucomas (exfoliative, pigmentary and chronic angle closure glaucoma), for whom close monitoring and therapy reconsidering was judged appropriate.Glaucoma suspects, demonstrating findings consistent with increased risk for glaucoma development, were included.

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Exclusion Criteria: Patients with missing data values for IOP

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Trial of pDNA CMV Vaccine (VCL-CT02) Followed by Towne CMV Vaccine (Towne) Challenge

Objectives of this trial are to:

Evaluate the kinetics and magnitude of the CMV-specific immune response post-Towne challenge (3000 pfu) in healthy CMV-seronegative volunteers who receive VCL CT02 administered (1 mg weekly x 3) 3 months previously compared to randomized controls who do not receive VCL CT02 as measured by:

1. antibody titers for gB;
2. T-cell IFN-g ELISPOT;
3. T-cell proliferation assays for IE1, pp65, and/or gB; and
4. cytokine and phenotypic flow cytometry responses to pp65, IE1, and/or gB.

Evaluate the safety safety of Towne challenge in healthy CMV-seronegative adult subjects who have previously been immunized with a trivalent pDNA CMV vaccine (VCL-CT02) administered intramuscularly.

Our hypothesis is that the immune response to Towne vaccine 3000 pfu challenge after VLC-CT02 priming will be greater than that after Towne vaccination alone.

This is a Phase 1, single-center, randomized, open-label trial of the live, attenuated Towne CMV vaccine administered as a "challenge" to healthy, CMV-seronegative, adult subjects who previously receive the CMV immunotherapeutic trivalent pDNA-based vaccine, VCL-CT02, given by intramuscular route at Days 1, 7 and 14 or who receive no VCL-CT02.

Up to 12 healthy, CMV-seronegative subjects will be enrolled. If a subject consents and meets all eligibility criteria, the subject will be randomized to the VCL CT02 (N=6)or control (N=6) groups. VCL CT02-assigned subjects will receive VCL CT02 (1 mg weekly x 3) and then on Day 77 will received Towne vacine (3000 pfu subcutaneously). Control-assigned subjects will receive Towne alone. Safety will be monitored and both antibody to CMV gB and T-cell responses to CMV antigens will be measured at specified intervals for 252 days post Towne challenge.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 45 years of age
* Normal lab values at study entry
* Good general health
* Negative CMV IgG antibody test

Exclusion Criteria:

* CMV seropositive
* Recent vaccination(s)
* Immunodeficiency
* Vaccination with investigational CMV vaccine(s)
* Pregnant or breast-feeding
Low Doses Amitriptyline & Chronic Neck Pain

The objective of this prospective randomized and controlled study is to evaluate the efficacy and safety of low dose of amitriptyline (5 mg) in the management of chronic neck pain.

Patients with chronic neck pain, lasting since at least 3 months, are recruited from our pain clinic. After verification of inclusion and exclusion criteria, patients consenting to enter the study are assigned randomly to one of the following groups: 1-Amitriptyline 5 mg for 2 months 2- placebo for 2 months. Co-morbidities and other painful conditions are noted, and then clinical evaluation of the patient is performed; pain is assessed according to Visual Analog Scale, anxiety, depression, insomnia and disability are evaluated by adapted scores (Bergen insomnia scale, neck pain disability score, neck pain diary \& anxiety and depression score). Patients are followed at 2 months and outcome measures are assessed.

Eligibility Criteria:
Inclusion Criteria:

* Chronic neck pain (since more than 3 months, and more than 15 days/month)
* Normal neurologic exam
* X-ray = normal or loss of lordosis

Exclusion Criteria:

* Neurologic signs or symptoms
* Past history of neck surgery
* MRI = abnormal findings except for loss of lordosis
* Past cervical trauma
* severe depression
* drug abuse
* pregnancy
* Follow-up not possible
* cardiac rhythms problems
* Glaucoma
* Urinary tract obstruction or prostatism
Mothers' Own Milk Optimization for Preterm Infants Project (MoMO PIP) Pilot Study

The overall goal of this study is to assess maternal vitamin D status along with diet, and milk composition, and in turn, to evaluate if infant vitamin D status can be improved with increased maternal supplementation and diet education. The central hypothesis is that by maximizing maternal vitamin D status in breastfed, preterm infants (\<35 weeks), there will be an increase infant 25(OH)D status at 1,2, and 3 months of age.


Eligibility Criteria:
Inclusion Criteria:

* Women with documentation of fully breastfeeding who present within one month of delivery, who are 18-45 years old and in good general health will be eligible for participation.
* Infants \<35 weeks corrected gestational age at birth

Exclusion Criteria:

* NO DMI/DMII, HTN, or parathyroid disease IF thyroid issues, currently euthyroid
* Multiple gestations
* No liver disease
* No major congenital abnormalities
* No kidney disease
* No inborn errors of metabolism
* No parathyroid disease
* No disorders of calcium metabolism
* No antiepileptics
* No steroids
* No congenital heart disease
* No severe illness at birth deemed incompatible with survival
Low Dose of Metronomic Cyclophosphamide and Capecitabine in Pretreated HER2-negative Metastatic Breast Cancer

The purpose of this study is to evaluate the role of low dose metronomic cyclophosphamide and capecitabine in pretreated metastatic breast cancer.

Metronomic chemotherapy has been considered as an effective strategy in metastatic breast cancer. This trial is designed to evaluate the role of low dose metronomic cyclophosphamide and capecitabine in pretreated metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Females with age between 18 and 80 years old
2. ECOG performance between 0-3
3. Life expectancy more than 3 months
4. Histological proven unresectable recurrent or advanced HER2-negative breast cancer
5. At least one previous therapy regimen (including endocrine therapy) for metastatic breast cancer;suitable for monotherapy (Neoadjuvant or adjuvant docetaxel should be completed at least one year).
6. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST1.1)
7. No anticancer therapy within 4 weeks
8. Adequate hematologic, hepatic, and renal function,No serious medical history of heart, lung, liver and kidney
9. Provision of written informed consent prior to any study specific procedures
10. Previous capecitabine is permitted, however, it should be completed at least 6 months.

Exclusion Criteria:

1. Pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound)
2. Women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study
3. Treatment with an investigational product within 4 weeks before the first treatment
4. Symptomatic central nervous system metastases
5. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
6. Patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
7. Uncontrolled serious infection
8. Patients with bad compliance
9. Patients lack of Dihydropyrimidine Dehydrogenase(DPD)
Intravenous Iron May Increase Depression Among Hemodialysis Patients

the aim of this study is to assess whether increased ferritin after intravenous iron therapy will lead to increased prevalence of major depression among treated patients.


Eligibility Criteria:
Inclusion Criteria:

1. age was above 19 years,
2. patient on maintenance hemodialysis,
3. patient had iron deficiency anemia (ferritin \> 100 ng/ml)

Exclusion Criteria:

1. patient has history of depression or already using antidepressant medication,
2. Lack of ferritin level increase ≥ 50% from baseline level before IV iron administration,
3. patient already on oral or intravenous iron supplement
Role of Pressure Bio Feedback in Management of Forward Head Posture for Computer Users at BUMDC

Objective: The aim of present study is to explore the effectiveness of pressure bio feedback in treatment of occupational forward head posture on computer users.

Material \& Methods: This Randomized Control Trial was conducted in Bahria University College of Physical Therapy, Karachi. Ethical approval was prior taken from Institute Review Board. there were 32 participants selected randomly equally in experimental and control group. Both male and female were included with age of 25 to 55 years currently employees of Bahria University (BUMDC) having forward head posture or complaining neck pain were included. Exclusion was age less than 25 years, history of cervical trauma or surgery, any neurological conditions or cervical pathology. Experimental Group was given DCF exercises with Pressure Biofeedback Unit (PBU) and Control Group was given Conventional DCF Exercises. SPSS version 23.0 was used for analysis.

Eligibility Criteria:
Inclusion Criteria:

- Both male and female age of 25 to 55 currently employees of Bahria University (BUMDC) having forward head posture complaining neck pain.

Exclusion Criteria:

* Students of Bahria University history of cervical trauma or surgery any neurological conditions or cervical pathology
S-1, Irinotecan, and Oxaliplatin in Locally-Advanced Pancreatic Cancer

This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection.

This phase II clinical trial will enroll patients with newly-diagnosed locally-advanced pancreatic adenocarcinoma and adopt the Simon's two-stage optimum design. After 4 cycles of SIROX regimen, patients will proceed to curative resection. The primary endpoint of this study is resection rate after neoadjuvant chemotherapy. The first stage will enroll 18 patients. We will go into the second stage if at least 2 patients in stage I become resectable after treatment. There will be at most 35 patients enrolled. Based on this trial, we anticipate that the SIROX regimen has comparable response rate and resection rate but lower toxicities comparing to FOLFIRINOX.

Eligibility Criteria:
Inclusion Criteria:

1. histologically or cytologically proven pancreatic adenocarcinoma
2. newly diagnosed, unresectable, locally-advanced pancreatic cancer
3. no potential of R0 resection at diagnosis
4. presence of measurable pancreatic lesion, which must meet the criteria of being ≥ 10 mm in at least one dimension by conventional CT/MRI
5. age between 20 and 79 years at registration
6. ECOG performance status (PS) of 0 or 1
7. adequate major organ functions
8. ability to take the oral study medication (S-1)
9. no clinically significant abnormal ECG findings within 28 days (4 weeks) prior to registration
10. voluntarily signed the written informed consent form

Exclusion Criteria:

1. pulmonary fibrosis or interstitial pneumonitis diagnosed within 28 days prior to registration
2. presence of diarrhea ≥ CTCAE v.4.03 grade 2
3. concomitant active infection
4. significant co-morbid medical conditions, including, but not limited to , heart failure, renal failure, hepatic failure, hemorrhagic peptic ulcer, mechanical or paralytic ileus, or poorly controlled diabetes
5. moderate or severe ascites or pleural effusion that requires drainage
6. prior or concurrent malignancies within the last 3 years, with the exception of carcinoma in situ of the cervix, or basal type skin cancer
7. concomitant treatment with flucytosine, phenytoin or warfarin
8. peripheral neuropathy grade of 2 or higher
9. known Gilbert syndrome or homozygosity for UGT1A1 promoter TA repeats prone to high risk of drug toxicity (screening of UGT1A1 genotype will NOT performed routinely before study)
10. pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients of childbearing age should have effective contraception for both the patient and his or her partners during the study period
11. severe mental disorder
12. judged ineligible by physician for participation in the study due to safety concern