cyrilzakka/clinical-trials huggingface dataset:
JointADventure: A Worksite Activity-Diet Intervention for Chronic Knee Pain

JointADventure: A worksite activity-diet intervention for chronic knee pain is a randomized controlled trial evaluation of a physical activity and nutritional worksite intervention to decrease symptoms and disability associated with knee osteoarthritis (OA), a major public health problem and a leading cause of work disability and work absenteeism/presenteeism in the US workforce.

The overarching goal of this project is to find an effective and sustainable intervention strategy that can assist large populations of persons with or at risk for knee OA to attain and maintain healthy dietary and physical activity behaviors. This project has to potential to have a tremendous impact on improving symptoms and quality of life of persons with chronic knee pain and decreasing the functional limitation, work absenteeism/presenteeism, and soaring healthcare utilization associated with knee OA.

We will utilize a partnership with Blue Cross Blue Shield of Illinois (BCBSIL), a highly supportive wellness partner, with a strong history of investment in the health of its employees and subscribers. The combined Activity/Dietary (AD) intervention is administered by health professionals trained in motivational interviewing as healthy lifestyle coaches.

Over the first 6 months, the coaches provide:

* individualized counseling based on a comprehensive assessment of baseline clinical, functional and behavioral factors that are barriers to healthy physical activity and dietary behaviors
* group education, the content of which is modeled after the highly successful Diabetes Prevention Program physical activity/dietary intervention, and customized for those with knee symptoms.

Follow-up assessments continue for 6 additional months.

Specific aims are to:

1. assess the feasibility of conducting a randomized controlled trial of the JointADventure intervention at this worksite
2. estimate the effectiveness of the intervention to decrease body weight, improve dietary habits, and increase objectively-measured physical activity
3. to improve objectively measured functional performance
4. to improve self-reported arthritis-specific and generic health status and health utility

Eligibility Criteria:
Inclusion Criteria:

* BCBSIL employee
* Must be able to ambulate household distances (50 ft)
* Must be able to read and speak English
* Pain, aching, stiffness in or around one or both knees on most days for at least one month during the past 12 months
* BMI of \>25, but \<40

Exclusion Criteria:

* Primary diagnosis of fibromyalgia
* Any co-morbidity that is more functionally limiting than the knee symptoms (e.g. spinal stenosis, peripheral vascular disease or residual effects of stroke)
* Comorbid condition (based on medication review) that contraindicates a physical activity or dietary intervention
* Total joint replacement surgery within 1 year or plans for total joint replacement in the next 12 months
* Plans to relocate away from the Chicago-land area in the next 12 months
* Being on a special diet that is inconsistent with the DASH diet
* Concurrent involvement in a weight loss program
Multi-cycle Prolon Diet

Evidence from bio-gerontology research from our laboratory and others have showed that short-term fasting/starvation (STS) can improve the efficacy of chemotherapy by protecting normal cells and tissues and potentially sensitizing malignant cells to chemo drugs. Furthermore, STS improves risk factors associated with aging and age-related disease in rodent models. Prolonged fasting, however, is difficult to implement and may not be feasible or safe in humans. We have developed a fasting-mimicking diet (FMD) that was well accepted in a pilot human trial. The objective of the study is to ascertain the impact of the fasting-mimicking diet given to adult subjects for 5 days a month for 3 consecutive months. The investigators hypothesize that the specially designed dietary regimen can reduce the risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.

The Phase I part of the study is designed as a randomized cross-over trial, including two arms: a Control arm and a multi-cycle special 5-day dietary regimen (Diet, 3 cycles) arm. After 3 cycles, the Control and Diet groups are crossed over such that the Control group will under-go dieting and the Diet group will return to normal diet. Participants will be monitored for body weight and physiological changes, as well as the adherence to the dietary intervention.

The Phase II part of the study is an expansion of the Phase I to ascertain the impact of the dietary intervention on risk factors for metabolic syndrome and biomarkers associated with aging and age-related diseases.

Statistical methods: Paired samples t-test and Mann-Whitney test will be used to compare between Control and Diet groups as well as pre- and post-diet values.

Eligibility Criteria:
Inclusion Criteria:

* Generally healthy adults
* BMI \>19 kg/m\^2

Exclusion Criteria:

* Severe hypertension (systolic BP \> 200 mm Hg and/or diastolic BP \> 105 mm Hg).
* Underweight (BMI \< 19 kg/m\^2)
* Females who are pregnant or nursing
* Special dietary requirements incompatible with the study interventions
* Significant food allergies which would make the subject unable to consume the study food
* Alcohol dependency (alcohol intake greater than two drinks per day for women and three drinks per day for men).
SFGH Health Advocates Stage II Study

The San Francisco General Hospital (SFGH) Health Advocate Staff II Study is a Randomized Controlled Trial (RCT) that collects survey data and non-invasive biological data from caregivers and children visiting a pediatric urgent care center. Families will be randomized according to a pre-determined randomization schedule into one of two social needs-focused interventions (the Health Advocates Program or a 211 Information active comparator arm). All patients in the study will be followed over a six month period to capture information about changes in social needs, health and health care utilization.

Adverse social circumstances like hunger and food insecurity can have dramatic, negative impacts on the health of vulnerable children. In safety-net settings, the prevalence of these adverse social circumstances are high. The investigators are proposing an RCT on an intervention based in a large urban pediatric urgent care setting that addresses patients' social circumstances. In an earlier RCT conducted in a similar setting, this intervention helped decrease total social needs and parent reported child health on a single item measure. In this study, the investigators will collect a more robust set of survey data including detailed measures of child health and non-invasive biological data from children and caregivers accompanying those children. Families will be randomized according to a pre-determined randomization schedule into the social needs-focused intervention. In one arm, the investigators will offer the intervention, which involves in-person navigation around available social and legal resources; in the other, the investigators will offer written information to participants on available community resources. All patients in both arms will be followed over a six month period to capture information about changes in participants' social needs, health and health care utilization.

Eligibility Criteria:
Inclusion criteria:

* Child/Parent-Legal Guardian Caregiver Dyad;
* Child is SFGH Pediatric Urgent Care Clinic Patient between 0 and 17 years of age;
* Parent or Legal Guardian Caregiver over or equal to 18 years old;
* English or Spanish speaking Parent or Legal Guardian Caregiver;
* Both reside in San Francisco County.

Exclusion Criteria:

* Non-English or non-Spanish speaking Parent or Legal Guardian Caregiver;
* Parent or legal guardian caregiver under age 18;
* Parent or legal guardian caregiver accompanying patient is not familiar with the child's living situation;
* Family participated in study previously;
* Non-San Francisco County resident;
* Foster child or child in clinic for a child protective clearance exam.
Anxiety in Relation to Nausea and Vomiting in Pregnancy

The goal of this observational study is to learn more about the relation between anxiety (assessed by GAD-7 questionnaire) and the nausea and vomiting in pregnancy (objectively measured by PUQE score).

Participants will answer 2 questionnaires: (GAD-7) for anxiety; and (PUQE score) for nausea and vomiting.

Study Procedures:

* Protocol approval will be sought from the ethical committee of the department of Obstetrics \& Gynecology, Faculty of Medicine, Ain Shams University.
* Recruitment of pregnant women complaining of nausea and vomiting in pregnancy (NVP) in first trimester will be done from the outpatient clinic and antenatal ward in Ain Shams University Maternity Hospital.
* An informed written consent will be taken from all participants before enrollment in the study.
* History taking, examination, and investigations (CBC, ultrasound, acetone in urine, serum sodium, potassium, alanine transaminase (ALT), aspartate transaminase (AST), serum creatinine) will be done to identify eligible patients according to the inclusion and exclusion criteria.
* PUQE score will be calculated for each patient. Patients will be classified into 3 groups (mild, moderate, severe) accordingly.
* GAD-7 questionnaire will be calculated for each patient. Degree of anxiety will be classified into 4 groups (minimal, mild, moderate, severe) accordingly.
* Data will be recorded in a case report form.
* Statistical analysis will be done accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in first trimester complaining of NVP
* Age (18-40) years

Exclusion Criteria:

* History of known medical problem (e.g., endocrine abnormalities, gastrointestinal disease).
* Known current or past psychiatric disorder (e.g., depression, anxiety, bipolar disorder, delirium, eating disorders, and psychotic disorder)
* Multiple pregnancy
* Known obstetric complications (non-viable pregnancy; either ectopic pregnancy; gestational trophoblastic disease, or miscarriage).
* Medications (including antidepressant, anti-psychotic or other psychiatric drugs during the last 6 months) or illegal drug or narcotic use that would affect the test results
* Current or past history of cognitive incompetence which can make it difficult to understand how to score GAD-7 questionnaire.
Dehydroepiandrosterone (DHEA) Intervention To Treat Ovarian Aging

* To test the hypothesis that supplementation of DHEA for at least twelve weeks prior to and during ovarian stimulation increases oocyte quantity (number of oocytes retrieved) and oocyte quality (clinical pregnancy rates and molecular markers) following IVF and IVF/ICSI treatment.
* To evaluate the feasibility of conducting a large multicentre trial

The purpose of this study is to evaluate the role of DHEA in counteracting the effects of ovarian ageing in an in-vitro fertilization (IVF) model. The study will examine whether the use of DHEA could improve clinical pregnancy rates following IVF treatment in women predicted to have aged ovaries by increasing oocyte quantity (ovarian response to gonadotrophins) and/ or by improving oocyte quality. The oocyte quality will be assessed by morphological and molecular markers.

This study will provide a mechanistic framework for translational research on mechanisms of ovarian ageing and drug interventions to slow down the ovarian ageing process and subsequent adverse physical and psychological consequences. Further, the data that will be produced from this research will have the potential to influence clinical practice in fertility clinics worldwide.

Eligibility Criteria:
Inclusion Criteria:

* Women aged above 23 years with diminished ovarian reserve (predicted to be poor-responder), defined as antral follicle count \<10 and/or Anti-Mullerian hormone \<5pmol/L
* Women undergoing IVF and IVF/ICSI treatment
* Women must have a regular spontaneous menstrual cycle of 21 - 35 days

Exclusion Criteria:

* Women with BMI \>35 Kg/M2
* Women with a single ovary
* Women with untreated hydrosalpinx/ submucous fibroid/ endometrial polyp at the start of treatment
* Women with any history of seizure disorders
* Women with previous participation in this trial in an earlier treatment cycle
* Women with any known endocrine disorders such as congenital adrenal hyperplasia, thyroid diseases, hyperprolactinemia
* Known allergy to DHEA
* Diabetic women on insulin as insulin lowers DHEA levels and might reduce the effectiveness of DHEA supplements.
NeuRx Diaphram Pacing System (DPS) Use in Amyotrophic Lateral Sclerosis (ALS)

The purpose of this research study is to collect more information about the use, safety, and effectiveness of the NeuRx DPS® in ALS patients.

Characterize the safety and benefit of on-label Humanitarian Device Exemption (HDE) use of DPS in patients with ALS who initiated noninvasive ventilation (NIV).

Eligibility Criteria:
Inclusion Criteria:

* Age 21 or older
* Familial or sporadic ALS diagnosed as possible, laboratory-supported probable, probable, or definite according to the World Federation of Neurology El Escorial criteria
* Bilateral phrenic nerve function clinically acceptable as demonstrated by bilateral diaphragm movement with fluoroscopic sniff test or with phrenic nerve conduction studies
* Chronic hypoventilation was documented by at least one of the following:

  * MIP (respiratory muscle strength) less than 60 cmH2O, or
  * Forced Vital Capacity (FVC) less than 50% predicted, or
  * PaCO2 greater than or equal to 45 mmHg, or
  * Nocturnal SaO2 (arterial oxygen saturation) less than or equal to 88% for at least five continuous minutes
* Initiation of non-invasive ventilation at or before time of enrollment
* Suitable surgical candidate to receive diaphragm pacing stimulation
* Negative pregnancy test in female participants of childbearing potential (treatment group)
* Informed consent from patient or designated representative

Exclusion Criteria:

* FVC less than 45% predicted within 10 days prior to surgery.
* Participation in simultaneous therapeutic clinical trial which could affect the safety or benefit outcomes of this study.
StroCare - Optimised Cross-sectoral,Coordinated Treatment of Stroke Patients With Patient-orientated Outcome Measurement

The Trial is a multi-centred controlled interventional study with a pre-post design. The primary aim of the study is the evaluation of the effectiveness and cost-effectiveness of the StroCare treatment.

Stroke is the second most common cause of death in Germany and the most common cause for life-long disability in adulthood. After stroke, patients often experience incisive changes in their health, daily routine and quality of life. The developed model of care (StroCare treatment) forms a cross--sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation. It aims to optimize the transition from acute inpatient treatment after an acute stroke to the ambulant neurological rehabilitation treatment. This is done firstly by creating an electronic portal solution for a safe and coordinated transmission of clinical data between the three participating hospitals and five stroke-specialized ambulant rehabilitation clinics and secondly by introducing a case-manager provided by the participating health insurance agency for patient support and aftercare coordination. The presented study is a multi-centred controlled interventional study with a pre-post design. Stroke patients in both groups are assessed after the index ischemic event and 12 months thereafter. Further sources of information are the medical record, the electronic portal (only intervention group), and routine data provided by the collaborating BARMER health insurance agency (for the Intervention and control group and additionally for a historic control). The main hypotheses are : (1) The StroCare treatment is more effective than the routine aftercare treatment (primary outcome: patient-reported physical quality of life) and (2) the StroCare treatment reduces costs for care and in the inpatient sector by providing more coordinated and thorough rehabilitation and outpatient aftercare.

Eligibility Criteria:
Inclusion Criteria:

* Patients in inpatient care in the stroke unit of one of the participating acute clinics who are insured at the BARMER health insurance agency with the following diagnosis (ICD-10):
* Ischemic attack (I63)
* Transient ischemic attack and related syndromes (G45)
* Intracerebral haermorrhage (I64)
* Written informed consent
* Sufficient mastery of German language

Exclusion Criteria:

* Substantially impaired communication capacity due to aphasia or dementia
* Patients with artificial Respiration
* Insufficient adherence
* Premorbid score of mRS≥4
* Patients with artificial Respiration (Z99.1)
* Dementia (F00.x., F01.x. or G30.x) or aphasia (R47)
* Death during inpatient Treatment or the Admission to a nursing home following the acute treatment
Amyotrophic Lateral Sclerosis: a New Paradigm

Amyotrophic Lateral Sclerosis (ALS) is a degenerative neuromuscular disease, progressing inexorably to respiratory failure, the by involvement of respiratory muscles, the commitment with most impact on the prognosis of ALS.

According to current knowledge, the clinical presentation of the disease is characterized by spinal or bulbar involvement, the latter being associated with a worse prognosis.

There are multiple factors described in the aetiology of ALS, as the successive damage the motor neuron, which can happen in high-impact athletes, or exposure to heavy metals. Genetic mutations are also described, being associated to a higher prevalence of ALS.

Data from retrospective studies with ALS populations reveal a prevalence of 4-8 cases per 100,000 persons. Research carried out in Trás-os-Montes e Alto Douro region (Northeast of Portugal) shows a high prevalence of ALS, with near 10 cases per 100,000 persons, with a recent increase in the bulbar involvement. The reasons for the high prevalence of ALS in this region are unknown.

The objective of this research is to pursue potentially involved genetic mutations in this disease (new or previously described), in addition to carry out a epidemiological questionnaire including data on personal history, environmental and occupational exposure that might be underlying this high prevalence.

Eligibility Criteria:
Inclusion Criteria:

* All patients with Amyotrophic Lateral Sclerosis sent to a medical consultation

Exclusion Criteria:

* Amyotrophic Lateral Sclerosis not confirmed
* Ages less than 18 years old
An Ascending Single-Dose Study of the Safety, Tolerability and Bioeffect of REGN1193

Study to assess the safety and tolerability of ascending single-doses of REGN1193 in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy men and women 18 to 45 years of age (inclusive)
2. Body mass index 18.0 to 30.0 kg/m\^2 (inclusive)
3. Normal standard 12-lead ECG
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide signed informed consent
6. For sexually active men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner\[s\] become pregnant) during and for up to 3 months after participation in the study.

Exclusion Criteria:

1. Any clinically significant abnormalities or other characteristics that would preclude the subject from safely enrolling or successfully completing the study
2. History of drug or alcohol abuse within a year prior to the screening visit
3. Current regular smoking, or a history of smoking greater than ½ pack
4. Receipt of an investigational drug within 30 days of screening, or within 5 half-lives of the investigational drug or therapy being studied (whichever is longer)
5. Significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that may adversely affect the subject's participation in this study
6. Known history of human immunodeficiency virus (HIV) antibody; and/or positive hepatitis B surface antigen (HBsAg), and/or positive hepatitis C antibody (HCV) at the screening visit
7. Hospitalization for any reason within 60 days of screening
8. History or presence of malignancy (including carcinoma in situ) prior to the screening visit
9. Any subject who is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff directly involved in the conduct of the protocol, or family member of staff involved in the conduct of the protocol
10. Pregnant or breast-feeding women

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).
Statin Intolerance in Patients With Myocardial Infarction

Patients with acute coronary syndrome (MI, NSTEMI, USAP) will be included. They will be screened for statin intolernace for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome

Exclusion Criteria:

* Being on statin, having statin related side effects
A Phase 2 Study of IC14 in Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome (ARDS) patients will be randomized to receive either IC14 (a single dose of 4 mg/kg followed by 2 mg/kg on Days 2-4) or placebo. Study participation will be for a total of 28 days.

Up to 160 patients with ARDS will be randomized to receive either IC14 at a dosage of 4 mg/kg on Study Day 1, then 2 mg/kg once daily on Study Days 2-4 or placebo for 4 days beginning within 48 hours of meeting inclusion criteria. Study participation will be for 28 days.

Eligibility Criteria:
Inclusion Criteria:

1. ICU admission
2. Age 18-70 years
3. Presence of a known ARDS clinical risk within 7 days of onset:

   1. Pneumonia
   2. Sepsis
   3. Trauma
   4. Aspiration
   5. Pancreatitis
4. Presence of ARDS (per Berlin criteria) defined as follows:

   1. Acute onset (\<48 hours)
   2. PaO2/FiO2\<300 on PEEP≥5
   3. Bilateral opacities consistent with pulmonary edema on frontal chest radiograph not fully explained by effusions, lobar/lung collapse, or nodules.
   4. Requirement for positive pressure ventilation via endotracheal tube
5. Anticipated duration of mechanical ventilation \>48 hrs

Exclusion Criteria:

1. Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry
2. Intubation for cardiopulmonary arrest
3. Do-not-attempt resuscitation (DNAR) status
4. Intubation for status asthmaticus, pulmonary embolus, myocardial infarction
5. Anticipated survival \<48 hours from intubation
6. Anticipated survival \<28 days due to pre-existing medical condition
7. Significant pre-existing organ dysfunction

   1. Lung: Currently receiving home oxygen therapy as documented in medical record
   2. Heart: Pre-existing congestive heart failure defined as an ejection fraction \<20% as documented in the medical record
   3. Renal: Chronic renal failure requiring renal replacement therapy
   4. Liver: Severe chronic liver disease defined as Child-Pugh Class C
8. Pre-existing, ongoing immunosuppression

   1. Solid organ transplant recipient
   2. Chronic high-dose corticosteroids (equivalent to \>20 mg/prednisone/day for \>14 days in the last 30 days)
   3. Oncolytic drug therapy within the past 14 days
   4. Known HIV positive with CD4 count \<200 cells/mm3
9. Current treatment with Enbrel® (etanercept), Remicade® (infliximab), Humira® (adalimumab), Cimzia® (certolizumab), or Simponi® (golimumab), Kineret® (anakinra), or Arcalyst® (rilonacept)
10. Pregnancy
11. History of hypersensitivity or idiosyncratic reaction to IC14
12. Deprivation of freedom by administrative or court order