cyrilzakka/clinical-trials huggingface dataset:
Neurofeedback Treatment of Pain in Persons With Spinal Cord Injury (SCI)

A number of studies suggest that training to increase different types of brain waves is related to pain relief. The purpose of the second phase of this study is to see if neurofeedback training might help people with chronic pain control their pain better. The information from the study may help the investigators treat chronic pain better in the future.

During this phase of the study, research personnel will provide up to 15 of the subjects with SCI-related pain with a full course (up to 40 sessions) of NF training to determine the effects of this treatment on (a) chronic daily pain, (b) EEG-assessed frequency band amplitudes, and (c) other measures of quality of life (specifically, sleep quality, fatigue, and pain interference).

Standard NF training procedures will be used that involve simply asking participants to relax while looking at the feedback screen and to "Do whatever is necessary to make and keep the color bar wide." EEG bandwidth activity that is associated with being pain-free or with experiencing less pain will be reinforced. This protocol will be repeated for up to 40 30-minute sessions, scheduled at least weekly (but more often if the participant and study PI can arrange this with their schedules. Brain wave activity will be measured three times during the study: once before treatment begins, once immediately after treatment ends, and three months following treatment. Research staff will collect data regarding pain intensity and quality of life from subjects via the telephone three times: before treatment, immediately after treatment, and three months after treatment ends.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years old or older.
2. At least 12 months post-SCI.
3. Otherwise healthy (i.e., no other secondary medical complications, such as pressure ulcers, that could impact pain scores).
4. Read, write and understand English.
5. Experience SCI-related pain on a daily basis.
6. Report an average pain intensity of at least 4 on a 0-10 Numerical Scale.
7. An individual must have one significant pain problem that is the worst or most painful if he/she has more than one pain problem.
8. Pain problem has lasted at least six months, and began after injury.

Exclusion Criteria:

1. History of seizure activity or has non-normative brain activity.
2. Suicidal or paranoid thoughts.
3. Presence of traumatic brain injury or significant skull defects.
Prevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort

Prospective study of sleep disordered breathing in a lung cancer screening cohort.

The proposed study is a prospective single arm study evaluating the prevalence of sleep disordered breathing in a cohort of lung cancer screening patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 55-75.
* \> 30 pack years tobacco exposure.
* Enrolled in lung cancer screening program.

Exclusion Criteria:

* Inability or unwillingness to undergo a home sleep study.
Treatment Protocol and Long-Term Outcomes in Craniofacial Fibrous Dysplasia

Craniofacial fibrous dysplasia (CFD) is a nonneoplastic disease characterized by fibro-osseous lesions in the affected bones. Treatment is mainly surgical and is stratified based on four different anatomical zones. This study aimed to evaluate the long-term outcomes and refine the algorithm for CFD.

According to Chen et. al for the appropriate surgical management of FD the craniofacial skeleton can be divided into four zones according to the consideration of facial cosmesis, vital anatomical region and function preserving. The aim of the study was to evaluate the outcome of nearly 40 years long-term follow up cohort group and refine the algorithm of surgical intervention of FD under 4 zones classification.

Eligibility Criteria:
Inclusion Criteria:

* Received CFD surgical intervention between 1972 and 2019
* Personal interviews: between late 2019 and 2020, covering a postoperative period of over 20 years
* All the surgery were performed by a senior surgeon (Yu-Ray Chen) at Chang Gung Craniofacial Center

Exclusion Criteria:

* Patients who underwent surgical treatment at other institutions during the follow-up period or those who did not return to the craniofacial outpatient department for follow-up and receive computed tomography scans between 2019 and 2020 will be excluded.
Metabolomic Profiling in Adolescents With Obesity and Diabetes

The purpose of this study is to identify unique metabolite signatures associated with the development of Type 2 diabetes and diabetic kidney disease in children.

We have a sub-study, with the purpose to validate the presence of a genetic marker (DENND1A) in the urine of adolescent females with polycystic ovarian syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Age of 13-19 years
* Gender: male and female
* Ethnic background: any
* Obesity will be defined as BMI \>95th percentile for age/gender
* Diagnosis of diabetes will be defined by current American Diabetes Association criteria
* Diabetes duration \< 2.5 years
* Absence of pancreatic autoimmunity (GAD65 and ICA512 and Insulin autoantibody)
* Adult caregiver willing to actively support study participation
* Signed parental informed consent form and adolescent assent form
* For PCOS substudy, the diagnosis of PCOS will be defined according to the 1990 US National Institute of Health (NIH) criteria (oligomenorrhea, clinical or biochemical signs of hyperandrogenism, and exclusion of other known disorders)

Exclusion Criteria:

* Creatinine clearance \<60 mL/min (calculated from estimated GFR)
* Other significant organ system illness or condition (including psychiatric or developmental disorder) that, in the opinion of the investigator, would prevent participation.
* For PCOS substudy, use of medications that effect androgen levels in the blood (i.e. oral contraceptive pills, or metformin) for the last 3 months prior to enrollment
Liraglutide as Additional Treatment in Patients With Type 1 Diabetes Mellitus

Evaluating the use of Liraglutide in patients with Type 1 Diabetes.

This investigation will be a retrospective chart review of in type 1 diabetics who have been treated with liraglutide. The study will be conducted at Diabetes-Endocrinology Center of WNY at Millard Fillmore Hospital, affiliated to the State University of New York at Buffalo.

Study Population: 40 patients with type 1 diabetes on treatment with either continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day on continuous glucose monitoring system (CGMS) will be included in the study. These patients with type 1 diabetes have been treated with liraglutide in addition to insulin. The investigators would retrospectively review their charts to evaluate decreases in fasting, postprandial and the overall mean glucose concentrations.

The investigators will compare the mean fasting, the mean weekly glucose and the standard deviation of weekly blood glucose concentrations as recorded by continuous glucose monitoring prior to and following one week and 12 weeks of treatment with liraglutide daily. In addition, the investigators will compare the time spent at glucose concentrations \>150 and 200mg/dl and \<70 and \<40 mg/dl. HbA1c levels before and after 12 weeks of treatment with liraglutide daily will be compared.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes Mellitus

Exclusion Criteria:

* Type 2 Diabetes Mellitus
CBT-I Intervention for Insomnia in Newly Diagnosed Cancer Patients

To determine the efficacy of a CBT-I intervention in improving sleep and other quality of life outcomes during cancer treatment. To assess the feasibility and acceptability of a CBT-I intervention among newly diagnosed cancer patients.

The proposed study will be a randomized controlled trial design. Participants will be randomized to either a CBTI treatment or a wait list control condition. The intervention is SHUTi, a validated web based version of CBTI, which will take place over seven weeks and will include a combination of face to face and telephone sessions, and email updates. All participants will have a face to face meeting with the doctoral student at enrollment. During the intervention period, all participants will be contacted by telephone at week 1, 3, and 6 to check in and to encourage participant engagement. However, during phone calls with control participants, no advice regarding sleep will be given and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study. Participants in SHUTi will additionally be provided the the doctoral student's phone number and will be encouraged to contact her if they have any questions during the intervention. They will also have the option of setting up appointments for face to face meetings during a clinic appointment if they desire additional therapist guidance. Pretreatment, all participants will complete a two week sleep diary and multiple self report measures. At the end of the intervention, all participants will complete a two week sleep diary and multiple self report measures again.

Eligibility Criteria:
Inclusion criteria:

* newly diagnosed with I-III non-metastatic cancer
* scheduled to begin chemotherapy or radiotherapy
* chemotherapy or radiotherapynaïve
* meet diagnostic criteria for chronic insomnia (i.e., lasting for at least one month)
* Chronic insomnia has been defined in previous research:as the presence of (1) three or more episodes of insomnia (i.e., ≥ 30minuteSOL, ≥ 60minute wake after sleep onset (WASO), or ≤ 6.5 hour total sleep time (TST) per night) of per week and (2) daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month.
* interested in behavioral sleep treatment
* have the permission of their oncologists to participate.

Exclusion criteria:

* untreated alcohol or substance abuse or dependence, bipolar, or psychotic disorder
* medical conditions such as seizure disorder, restless leg disorder, or Parkinson's disease
* untreated sleep disorders such as sleep apnea
Evaluation of the Possible Relationship Between Periodontal Disease and Preterm Labor

The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preterm labor.

The secondary objective of the study is to analyze the relationship between preterm labor and periodontal infection, using clinical, biochemical and microbiological methods.

Preterm infants are born prior to completion of 37 weeks of gestation. Periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preterm labor. It is believed that the results will set light to the etiology of preterm labor and will help to develop strategies to prevent the disease.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women with preterm labor
* 37. weeks of pregnant women with no history of preterm labor

Exclusion Criteria:

* Genitourinary infection
* pregnancy or pre-pregnancy hypertension
* HIV infection
* diabetes mellitus
* multiple pregnancy, preterm labor / low birth weight
* smoker and alcohol use history
* IVF pregnancy
* placental, cervical and uterine anomalies
* pregnancy with intrauterine growth retardation
* pregnancies with congenital or chromosomal fetal anomalies
* significant vaginal bleeding
* infertility stories
* drug addicts
* poor socioeconomic level
Alcohol Biosensor Monitoring for Alcoholic Liver Disease

Successful treatment of alcohol associated liver disease (AALD) depends primarily on abstinence from alcohol. The investigators propose a randomized clinical trial of alcohol biosensor monitoring for patients with alcohol associated liver disease to determine if monitoring with feedback on alcohol use patterns reduces alcohol consumption and improves outcomes.

The investigators propose a 3 month randomized controlled trial (RCT) pilot of alcohol biosensor monitoring (ABM)(WrisTAS) for patients with Alcohol Associated Liver Disease (AALD) who intend to stop drinking. All participants will wear the ABM device but participants will be randomized to receive either personalized feedback on the data recorded on the device (n=30) or enhanced usual care without feedback on device data (n=30). The investigators will determine whether ABM plus feedback improves outcomes for AALD patients compared to enhanced usual care and hypothesize ABM feedback will reduce alcohol consumption, improve motivation and self-efficacy for abstinence and improve engagement in treatment. The investigators will also conduct research including qualitative data collected from participants who will provide opinions on ABM feasibility, acceptability, and usability. Qualitative methods are especially useful for understanding the perceived needs, barriers, and preferences for monitoring alcohol use and are especially required for future translation of this technology into clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients with AALD followed at our liver disease clinic,
* 18 years or older,
* willing to accept randomization,
* and agree to wear device for 3 months,
* SOCRATES problem recognition subscale score \>26 (scores \<26 indicate very low recognition of an alcohol problem).

Exclusion Criteria:

* Non-English speaking,
* Montreal Cognitive Assessment (MOCA) scores \<21 (moderate cognitive impairment) or neurologic diseases (e.g. Parkinson's),
* patients with unresponsive acute alcoholic hepatitis, multi-organ failure, fulminant hepatic failure,
* cancer/terminal illness;
* those unable to wear a wrist monitor (e.g., edema);
* lacking a residence, or unable to identify a contact person (if lost to follow-up).
Tertiary Prevention by Exercise in Colorectal Cancer Therapy

The purpose of this study is to determine the feasibility of a one year exercise training program in post-surgical patients with colorectal cancer.

Apart from a genetic predisposition lifestyle factors (low physical activity, nutrition, and obesity) increase the risk of colorectal cancer. Furthermore, in observational studies increased physical activity has shown to improve the prognosis in patients after the diagnosis of colorectal cancer. However, there are currently no prospective randomized controlled trials which prove the causal relationship between exercise and prognosis in colorectal cancer patients. The long-term aim of this study is to evaluate whether physical activity of ≥ 18 MET-h (Metabolic equivalent task-hours) per week significantly improves disease free survival in colorectal cancer survivors (stage UICC II/III). In the first instance, structure-, process- as well as outcome-characteristics need to be investigated within a feasibility study (F-PROTECT). Essential aims are to establish collaborations with clinics and training centres, to achieve the required recruitment numbers, and to conduct the training intervention.

Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed nonhereditary primary Stage II or III colon cancer diagnosis or rectal cancer
* written informed consent in German
* histopathologically confirmed R0-resection
* start of guideline conformed adjuvant chemotherapy within 12 weeks after R0-resection in Stage III colon cancer diagnosis (if necessary in Stage III colon cancer diagnosis)

Exclusion Criteria:

* hereditary colon cancer diagnosis
* R1 and R2 resection
* clinically relevant complications during recovery
* secondary neoplasm
* non-continuance of guideline conformed therapy
* uncontrolled infection
* manifest cardiac disease (e.g. unstable CAD, heart failure (NYHA IV), malignant hypertension)
* clinical relevant respiratory disease (GOLD IV)
* musculoskeletal disorders severely restricting the patients mobility (e.g. gonarthrosis, coxarthrosis)
* cirrhosis of the liver (Child B and C)
* Karnofsky performance status scale ≤ 60%
* maximal exercise capacity ≤ 50 watt
* clinically relevant lab factors (leukocyte count ≤ 3000/μl, thrombocyte count ≤ 20.000/μl, hemoglobin \< 8 g/dl)
* physical activity level ≥ 18 MET-h/ week at screening
Study of the Cytokine Response During Exercise Dyspnea in Patients With Chronic Obstructive Pulmonary Disease (COPD). Effect of Body Composition

Dyspnea, more commonly known as breathlessness, is a symptom found in the majority of patients with chronic obstructive pulmonary disease (COPD), with a major impact on quality of life and mortality.

COPD is a chronic inflammatory disease of the bronchi, affecting 8% of the French population (more than 3 million people). By 2030, it will be the third leading cause of death worldwide. Effective management of dyspnea in these patients is a priority.

In patients with severe COPD, physical exertion increases the workload of breathing, leading to dyspnea. At the same time, the respiratory muscles and fatty cells release cytokines, myokines and adipokines - a group of proteins involved in the inflammatory response. In addition, 15% of COPD patients suffer from sarcopenia (loss of muscle mass and strength) which increases respiratory effort and dyspnea.

Our research project aims to study the effect of dyspnea relief in COPD patients on cytokine, myokine and adipokine levels, taking into account the presence of sarcopenia. Indeed, it is possible to alleviate the workload of the respiratory muscles during exercise by means of respiratory assistance.

The ultimate goal is a better understanding of dyspnea mechanisms, to enable the development of cytokine-targeted therapies and improve quality of life and survival in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient affiliated to a social security scheme.
* Patient capable of giving free, informed, written and signed consent.
* Male gender
* Severe COPD (Chronic Obstructive Pulmonary Disease) diagnosed according to GOLD criteria, in a stable state, with a forced expiratory volume (FEV1) from 30 to 50% of the predicted value (measured within one year during respiratory function tests (RFT)
* History of smoking \>10 pack-years with cessation of smoking for more than 12 months.
* Patient judged by the investigator to be able to tolerate inspiratory pressure during a preliminary cycling exercise test.

Exclusion Criteria:

* Severe anxiety disorders, assessed by the STAY Y-B form questionnaire; a score above 65 indicates very high day-to-day anxiety.
* Patient under guardianship/trusteeship/supervision of justice
* Chronic hypercapnia at rest (CO2 arterial pressure ≥ 50mmHg)
* Chronic use of non-invasive ventilation
* Known pulmonary hypertension
* Chronic administration of oral corticosteroids
* Unstable heart disease
A Study of Self-administered Misoprostol to Prevent Bleeding After Childbirth in the Community (MamaMiso)

Postpartum hemorrhage (PPH) is a major cause of maternal death in the developing world. An important strategy in the prevention of deaths is the use of uterotonic drugs for PPH prophylaxis. Misoprostol has been recognized as an option for preventing PPH as it is economical, heat stable, has a long shelf-life, and can be taken orally.

The investigators envisage that the use of self administered misoprostol after home births among mothers would be associated with a peri-partum fall in hemoglobin value of over 20% (the outcome of a fall of 2g/dl will also be tested in the pilot).

The objective of the main study will be to assess the effectiveness and safety of antenatal administration of misoprostol tablets (600mcg) for self administration immediately following home delivery for the prevention of postpartum haemorrhage. The objectives of the pilot study are to test the integrity of the study protocol, to test the randomization procedure, to assess the acceptability of the intervention, to test the logistics of follow-up, to test the data collection forms, to validate the quality of life questionnaire in this population and to determine the recruitment rate to help study planning.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women living in the recruitment villages of Mbale district at \>34 weeks gestation

Exclusion Criteria:

* Any woman with a known allergy to misoprostol or other prostaglandins will be excluded as will any woman under 18 years old (unless she is an emancipated minor)
Bed Rest, Inactivity and Early Responses

To evaluate the early metabolic responses (whole body and within muscle tissue) to a single day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of inactivity per se vs alterations in diet


Eligibility Criteria:
Inclusion Criteria:

* Healthy and aged 18-40 y
* BMI between 18 and 30

Exclusion Criteria:

* On medication
* Family history of metabolic disease
* Diagnosed with any metabolic or cardiovascular conditions
* BMI \< 18 or \> 30
Study in Healthy Adults Evaluating PF-07202954

The study is planned as a 3 part design with investigator and participant blinded (sponsor-open), placebo controlled, randomized, dose escalation in Part 1 and Part 2; and a randomized, open label design, in Part 3 (if conducted).


Eligibility Criteria:
Inclusion Criteria:- healthy subjects (all 3 Parts)

* evidence of steatosis on FibroScan (Part 2 only)
* BMI 17.5 to 30.5 kg/m2 (Part 1, Part 3)
* BMI 17.5 to 35.4 kg/m2 (Part 2) Exclusion Criteria:- evidence of clinically significant disease
* subjects on chronic medications
* clinically significant, abnormal laboratory results, vital signs, or cardiac conduction abnormalities
* contraindication to MRI (Part 2, only)
A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)

The purpose of this study is to confirm the efficacy of Aricept in patients with dementia with Lewy bodies (DLB).


Eligibility Criteria:
Inclusion Criteria

1. Patients diagnosed with probable DLB according to the diagnostic criteria for DLB
2. Patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients at least 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance, and escort the patients on required visits to study institution
3. Clinical Dementia Rating (CDR) score is greater than or equal to 0.5
4. Mini-Mental State Examination (MMSE) score is greater than or equal to 10 and less than or equal to 26

Exclusion Criteria

1. Patients diagnosed with Parkinson's disease with dementia (PDD)
2. Patients who have received anti-dementia drug therapy within 12 weeks before the start of the observation period
3. Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency
4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than or equal to IV)
5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/minute at screening test