cyrilzakka/clinical-trials huggingface dataset:
Examination of the Effects of Four Different Spices on Energy Metabolism

The objective of this study is to examine whether four different spices (ginger, black pepper, horseradish and mustard) are able to increase energy metabolism.

Since chili and other spices have been shown to increase energy expenditure compared to placebo, we expect that some or all of the four spices may actually increase energy expenditure - although not to a large degree.

Several pungent food ingredients, such as chili,and also other bioactive food ingredients, e.g. green tea, have been shown to be able to increase energy expenditure and fat oxidation during the hours following a meal containing the bioactive ingredient. Furthermore, we will also look at the subjects own feelings of appetite and thereby examine whether the appetite is affected by the spicy food. We expect to see some small effects on these parameters.

Eligibility Criteria:
Inclusion Criteria:

* male
* healthy and not use medication (regularly)
* normal weight
* non smoker
* tolerate and like spicy food
* stable body weight last two months

Exclusion Criteria:

* increased blood pressure
* abnormal EKG
* mental, metabolic and chronic diseases
Home-Based Dual-Task Training for Older Adults

This project is focused on conducting a home-based, thinking while moving exercise intervention for adults 65 years or older, who have mild cognitive impairment, that will integrate several effective training modalities including non-contact cardio-kickboxing, stepping exercise, balance/functional training, and muscle strengthening. Cognitive function, physical function, and dual-task abilities will be assessed over the 12-week intervention and comparisons will be made between participants in the exercise intervention and control participants receiving no intervention.


Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* Male or female
* Screened positive for mild cognitive impairment (Montreal Cognitive Assessment score 23 to 26 points
* Having no absolute contraindications to non-physician supervised exercise.

Exclusion Criteria:

* Lower-body amputation
* Non-English language speaker
The Effect of Mobile Health-based Exercise on Hepatocellular Carcinoma Patients With Insulin Resistance

Exercise is predicted to have positive effect among patients with hepatocellular carcinoma (HCC). However, little attention has been paid to the role of physical activity with wearable device in the management of HCC patients in the aspect of improvement in insulin resistance.

We designed this study to investigate whether personalized exercise with mobile health program improves insulin resistance without decompensation in HCC patients with insulin resistance.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20 to 70 years
* Patients who were diagnosed with early-stage HCC, defined by modified UICC stage 1 or 2
* Patients with treatment-naive and recurrent HCC who have received treatment and achieved complete response at the time of screening
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patients with insulin resistance (HOMA-IR \>=2.2)

Exclusion Criteria:

* Child Pugh class B or C
* Alcohol intake \>20g/day
* History of decompensation
* Severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure \> 200/120 mmHg) or psychiatric illnesses which limit ability to exercise safely
* Who takes insulin sensitizer (sulfonylurea, biguanide, thiazolidinedione, glucagon-like peptide-1 agonist, dipeptidyl peptidase-4 inhibitor) or uses insulin
* Uncontrolled diabetes mellitus (Hemoglobin A1c \>10%)
Implementing Genomics in Practice (IGNITE) Proof of Concept Study: Genotyping in Family Medicine Clinics

This study will examine the effect of having genotype information on pain management and pain control for patients treated in family medicine clinics. This study will also examine physician-perceived usefulness of genotype information. Patients will be enrolled from family medicine clinics serving as either implementation sites or control sites. Patients from implementation sites will undergo genotyping, while those from control sites will not by genotyped.

Codeine and tramadol are opioid analgesics that depend on cytochrome P450 2D6 (CYP2D6) for bioactivation to morphine and O-desmethyltramadol, respectively. Morphine and O-desmethyltramadol have much greater affinity for the opioid receptor and thus are more powerful analgesics.

Individuals with genotypes associated with low CYP2D6 activity (poor metabolizers) are unable to convert sufficient amounts of codeine or tramadol to their active metabolites and may fail to derive sufficient pain relief. At the opposite extreme, individuals with genotypes associated with increased CYP2D6 activity (ultra-rapid metabolizers) are at risk for serious toxicity with usual codeine or tramadol doses.

The CYP2D6 genotype also has implications for response to other drugs, such as tricyclic antidepressants (TCAs), which are commonly used for neuropathic pain.

Patients will be recruited from family medicine clinics, serving as either implementation sites or control sites. Patients from implementation sites will undergo CYP2D6 genotyping, with results placed in the medical record to assist with prescribing of pain medications. Pain medications prescribed from baseline to 3 months will be assessed through medical record review. A pain assessment questionnaire will be administered to patients enrolled from both sites at baseline and 3 months.

At the end of the study, a 20-item survey will be administered to physicians at the implementation sites. We will assess whether having CYP2D6 genotype results is useful to inform prescribing decisions for pain medication from the physician's perspective.

We will also assess medicines prescribed to patients enrolled from both sites over the 12-month period after enrollment from medical record review and determine the number of patients who were prescribed a medication that has genetic information in its FDA-approved label.

Eligibility Criteria:
Inclusion Criteria:

* Treated in family medicine clinic
* History of pain for at least 3 months
* Prescribed medication for pain relief

Exclusion Criteria:

* Pain for less than 3 months
* Not currently prescribed any medication for pain
Tailored Bilio-Pancreatic Limb and HbA1c 10 Years Post Mini-Gastric Bypass

Diabetes is now or soon will be a worldwide epidemic. Diabetes has impact on both healthcare costs in addition to the costs in human lives, suffering and disability. Treatment that lowers Hemoglobin A1c (HbA1c) improved outcomes. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy was the most effective surgical technique in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the HbA1c changes.

There is general agreement that Diabetes is now or soon will be a worldwide epidemic. Studies also make clear the devastating impact of diabetes on both healthcare costs in addition to the costs in human lives, suffering and disability. It is also clear that treatment that lowers Hemoglobin A1c (HbA1c) will result in improved outcomes proportional to the decrease, saving both lives and costs. Unfortunately medical and lifestyle therapy routinely result in less than ideal resolution of elevated HbA1c levels. Studies have demonstrated that both general surgery and bariatric procedures may improve or reverse diabetes. In several studies the Billroth II reconstruction following gastrectomy is the most effective surgical technique in improving or reversing Diabetes. The purpose of this study is to analyze the outcomes of the Mini-Gastric Bypass-Original Technique (MGB-OT) version of the One Anastomosis Bypass (OAGB) to investigate the association of a "Tailored" Bilio-pancreatic Limb Length (BPLL) with the HbA1c changes.

Eligibility Criteria:
Inclusion Criteria:

* Mini-Gastric Bypass -Original Technique post operative patients

Exclusion Criteria:

-
Safety and Efficacy of BAFFR CART for Relapsed/ Refractory Neuromyelitis Optica Spectrum Disorder

This is an open-label, single-arm, dose-escalation study in up to 20 participants with relapsed/refractory Neuromyelitis Optica Spectrum Disorders (NMOSD). The aim is to evaluate the safety and efficacy of the treatment with BAFFR CART.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged 18-60 years;
2. Patients must be diagnosed as AQP4-IgG-positive NMOSD;
3. At least one immunosuppressant has been used for over a year with poorly controlled symptoms;
4. Clinical evidence of at least two relapses in the last 12 months or three relapses in the last 24 months and one relapse in the preceding 12 months before screening.
5. Subjects and their partners must be willing to use effective and reliable methods of contraception, devices or medicines, within one year before BAFFR CART cells infusion.
6. Subjects must provide written informed consent before the study begins and comply with the requirements of the study protocol.

Exclusion Criteria:

1. Subjects have received B cell deletion treatment within 6 months before screening;
2. Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.
3. Subjects with Papovaviruses infection.
4. Subjects have received live attenuated vaccine vaccination within 8 weeks before screening; or plan to receive live vaccine vaccination within 8 weeks after treatment;
5. History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.
6. Pregnant or lactating women.
7. Subjects with severe heart, liver, kidney or bone marrow function disorder.
8. Allergic constitution or a history of severe allergies.
9. Subjects with conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.
Dairy vs Plant-based Beverages for Improving Bone Health During Exercise

This study will evaluate the effects of consuming dairy milk versus two plant-based beverages (pea-based, and almond-based) after resistance training sessions (3 times per week for 12 months) on bone properties (bone mineral density, bone geometry), body composition, strength, and functional performance in post-menopausal women and men 50y and older.

The purpose of the study is to compare consumption of dairy milk (1% chocolate milk) to plant-based beverages (protein-matched pea beverage and low-protein almond beverage) after resistance-training sessions on bone mineral density, bone geometric properties, lean tissue and fat mass, muscular strength, and functional performance. One-hundred and fifty postmenopausal women and men 50y or older will be randomized to one of three groups: 1) Dairy milk; 2) pea-beverage; 3) almond beverage. The study will be double-blind, accomplished by chocolate flavoring of each beverage. Participants will do supervised strength-training sessions three times per week for 12 months. After each strength-training session, participants will consume 375 ml of their beverage and then consume 375 ml of their beverage again one hour later.

Eligibility Criteria:
Inclusion Criteria:

* Women need to be postmenopausal (no age limit)
* Men need to be 50y or older

Exclusion Criteria:

* Taking medications that might affect bone
* Conditions that might preclude participating in a resistance-training program (determined by the "Get Active Questionnaire").
* Planning 6 weeks of travel during the 12 month intervention period
* Planning major surgery during the 12 month intervention period
* Already strength training greater than 2 days per week for 30 minutes or longer per session
* Allergies to ingredients in the beverages
Control Study of Nautilus BrainPulse for the Detection of Concussion

To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's signal patterns with those of concussed high school athletes.

This study is a non-blinded study in high school athletes who will be presumed to no be suffering from a concussion. Healthy controls will be recruited from high school sports that are not associated with physical contact, which could generate concussions.

The primary objective of this study is to improve Jan Medical's signal analysis. Jan Medical will perform analysis.

Eligibility Criteria:
Inclusion Criteria:

* Male and female between 14 and 19 years of age
* Participating in non-contact sport at the Freshman, JV, and varsity level in a Bay Area High School
* Able to provide signed informed consent or have a legally authorized representative willing to provide informed consent on the subject's behalf

Exclusion Criteria:

* History, if any, of concussion or stroke
* History, if any, of alcohol or drug abuse
* History, if any, of mental disorder or cerebrovascular disorder
* Pregnant women
* Failure to comply with recording schedule
* Not suitable for participation in the study in the opinion of the PI
* Have suffered a concussion during the study
* Plays a contact sport (ex- football, lacrosse, basketball, soccer, ice hockey, cross-country)
* Related to a Jan Medical employee
Cognitive Behavioral Therapy for Insomnia: Face-to-Face Versus Telemedicine

The purpose of this study is to compare the effectiveness of Cognitive-Behavioral Therapy (CBT) for insomnia conducted face-to-face with a therapist versus CBT for insomnia conducted using Internet-based videoconference technology.

The objective of this clinical trial is to compare the effectiveness of telemedicine Cognitive-Behavioral Therapy (CBT) for insomnia \[via the American Academy of Sleep Medicine Sleep Telemedicine (AASM Sleep TM) platform\] to gold standard face-to-face CBT for insomnia. The central hypothesis is that CBT for insomnia delivered by AASM SleepTM will be comparable to face-to-face CBT for insomnia for clinical outcomes and patient satisfaction, but AASM SleepTM will be a more cost effective treatment modality (primarily through reduced costs associated with facility use and patient time). The rationale for the proposed project is rooted in the critical need to disseminate CBT for insomnia using the most effective and efficient modalities, with recognition that therapist involvement likely produces the most favorable outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Current diagnosis of insomnia

Exclusion Criteria:

1. Suspicion of or inadequately treated sleep disorder other than insomnia
2. Presence of psychiatric disorders for which CBT for insomnia may be contraindicated
3. Unstable chronic medical condition directly related to insomnia
4. Routine overnight shift work
5. Previous failed adequate trial of CBT for insomnia
6. Unstable dose of sleep medications
7. Lack of access to reliable WiFi connection in the home
Clinical Observation on Bone Metabolism Induced by Chronic Renal Insufficiency

Patients with chronic renal insufficiency usually develop secondary osteoporosis or bone loss, which is called renal osteodystrophy. Most of the previous studies focused on bone metabolism of patients in late stage of chronic renal insufficiency, especially those with chronic dialysis. In this study, bone metabolism of patients in different stages of chronic renal insufficiency will be observed to reveal the mechanism of development of renal osteodystrophy and provide clues for early intervention on renal osteodystrophy.

In this study, patients with chronic renal insufficiency (CKD1-5, defined by glomerular filtration rate，GFR) and healthy people as control will be recruited (50/group, total 300). Blood urea nitrogen, creatinine,lumbar and hip bone mineral density, bone turnover biochemical markers including serum total propeptide of type I procollagen（PINP）, bone alkaline phosphatase（BALP）, bone Gla-protein (BGP) and β-CrOSSlaps（β-CTX）, serum calcium and phosphorus and related regulators including fibroblast growth factor 23 (FGF23), 25-hydroxyl-Vitamin D （25-OH-VitD）, parathyroid hormone（PTH） will be detected. The relationship between kidney function and bone turnover, and the rules throughout the development process of renal osteodystrophy will be analysed.The micro ribonucleotide（miRNA）array will also be performed to screen the biomarkers of renal osteodystrophy in different stage.

Eligibility Criteria:
Inclusion Criteria:

1. 20-50 years old
2. chronic renal insufficiency (Control: normal kidney function; Case: CKD 1-5)
3. be willing to and be able to join in the study and signed informed consent
4. have not accepted systematical treatment on bone loss or osteoporosis

Exclusion Criteria:

1. allergies
2. secondary osteoporosis caused by other diseases.
3. postmenopausal women
4. mental illness or psychosis
5. patients with bone fracture and need surgery treatment
6. taking any medicine that will affect bone metabolism for a long time and can not stop
7. women during pregnant stage and breast-feed stage
8. with deformity or disability
The Effect of Duration Between Sessions on Microperimetric Biofeedback Training in Patients With Maculopathies

Patients who develop macular diseases have several clinical complications,such as central vision loss, the central scotoma of the visual field, the decrease of reading speed and fixation stability. At present, there is still no satisfactory effect in the prevention and treatment of advanced macular disease. A new rehabitation strategy named microperimetric biofeedback training has been shown to be effective in improving patients' visual appearance, but there is no consensus regarding the optimal methodology and standard of practice. Therefore, we designed a prospective clinical study to verify the effectiveness of MBFT and to determine an optimal plan.

The present study aimed to investigate the effects of training frequency and number of training sessions on the visual outcomes of patients with various macular diseases. A total of 15 training sessions were conducted on two distinct frequencies, namely once a day and once every other day. Baseline measurements included fixation stability, reading speed, and best corrected visual acuity (BCVA) were obtained and followed up after the 5, 10, and 15 training sessions. By comparing the changes in these visual function parameters across different stages of training, the study aimed to identify and analyze the underlying patterns and rules governing the training process. Ultimately, the results of this study could serve as a valuable reference for standardizing the use of MBFT in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

participants who (1) were diagnosed with macular disease and had a BCVA poorer than 20/60; (2) with stable fundus lesion in fundus examinations; (3)with education level beyond the third grade; (4)had no other effective treatment; and (5)were willing to improve visual quality.

Exclusion Criteria:

who (1) received ocular treatments in the preceding 3 months, (2) with active fundus lesions like inflammation, bleeding, exudation, edema, (3) with obvious opacity of the refractive media such as keratopathy, severe cataract, or severe vitreous opacity, (4) were unable to attend scheduled follow-up appointments.
A Phase II Study of Iressa in Patients With Chemo Refractory Germ Cell Tumors Expressing EGFR

This study will evaluate the use of ZD1839 in the treatment of subjects with refractory germ cell tumors. Subjects will take ZD1839 for one year in the absence of excessive toxicity or decision to withdraw.

The primary objective is to determine the response rate of ZD1839 in patients with refractory germ cell tumors expressing EGFR. The secondary objectives are to determine the duration of response, time to progression and overall survival in patients with refractory germ cell tumors expressing EGFR and treated with ZD1839; to evaluate the tolerability of ZD1839 in patients with refractory germ cell tumors and to correlate tumor response to degree of EGFR expression by immunohistochemistry.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or serologic proof of metastatic germ cell neoplasm(gonadal or extragonadal primary) with disease not amenable to cure with either surgery or chemotherapy. Patients w/ seminoma and non-seminoma are eligible, as are women w/ ovarian germ cell tumors.
* Evidence of recurrent or metastatic carcinoma
* Must have received initial cisplatin combination therapy \& demonstrated progression following the administration of at least one "salvage" regimen for advanced germ cell neoplasms.
* Patients are eligible after first line platinum bsed chemotherapy if their disease has relapsed and they have primary mediastinal non seminomatous germ cell tumor, late relapse or progressed w/in 4 wks of last platinum dose.
* immunohistochemical documentation of EGFR expression documented.
* adequate organ function: ANC \>/=150,plt \>100K, total bili \</= upper limit of normal(ULN). Pts w/ liver mets up to 3x ULN.Transaminases up to 1.5 x ULN if alk phos is \</=ULN or alk phos may be up to 4x ULN if transaminases are \</= ULN. Pts w/ liver mets may have alk phos up to 5x ULN. Serum crt \</= 2.0.
* ECOG performance status 0-2.

Exclusion Criteria:

* Must be 3 weeks post major surgery, radiotherapy, or chemotherapy and hae recovered from all toxicity.
* Active unresolved infection and/or are receiving concurrent treatment with parenteral antibiotics are ineligible.
* Patients requiring steroids for symptomatic brain metastasis are not eligible.
* Pregnant or lactating patients are not eligible.
* Class III/IV heart disease