cyrilzakka/clinical-trials huggingface dataset:
C1q/TNF-related Proteins in Non-Alcoholic Fatty Liver Disease

Non-alcoholic fatty liver disease (NAFLD) is characterized by an accumulation of fat in the liver, which is one of the most common forms of chronic liver disease in developed countries. In western countries, the prevalence of NAFLD in the general population is estimated to be 20-30%; in obese populations, this increases to 57.5-74%. But, it hasn't been clearly elucidated yet regarding the underlying disease pathophysiology and treatmet strategy.

Recently, members of the C1q/tumor necrosis factor-related protein (CTRP) family have been reported to share structural homology with adiponectin. To date, 15 CTRP family members have been found that might play major roles in glucose metabolism and inflammation.

The investigators tried to clarify the relationship between CTRP family and NAFLD in Korean men and women.


Eligibility Criteria:
Inclusion Criteria:

* 20\<age\<80
* apparently healthy subjects

Exclusion Criteria:

* a history of CVD
* diabetes
* stage 2 hypertension
* malignancy
* severe renal or hepatic disease
A Study of Participants With Lymphoma Who Take R-CHOP and Enzastaurin Compared to Participants Who Take R-CHOP Only

To compare R-CHOP plus enzastaurin versus R-CHOP for progression-free survival (PFS) time measured in participants with intermediate and/or high risk for diffuse large B-cell lymphoma (DLBCL) receiving first-line treatment.


Eligibility Criteria:
Inclusion Criteria:

Participants must:

1. Have a histologically confirmed diagnosis of DLBCL based on the World Health Organization classification (Harris et al. 1999) at the time of original diagnosis. Pathology must be reviewed and confirmed prior to enrollment at the investigational site where the participant is entered. Participants with a prior history of an indolent lymphoma or a histological diagnosis of follicular Grade 3 lymphoma will not be eligible for enrollment.
2. Have received no prior chemotherapy.
3. Have an International Prognostic Index (IPI) score ≥2 at time of original diagnosis.
4. Have a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology group (ECOG) scale.
5. Have adequate organ function as follows:

   * Hepatic: total bilirubin ≤1.5 times the upper limit of normal (x ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤1.5 x ULN, (≤5 x ULN, if liver involvement).
   * Renal: serum creatinine ≤1.5 x ULN.
   * Adequate bone marrow reserve: platelets ≥75 x 10\^9 per Liter (L), absolute neutrophil count (ANC) ≥1.0 x 10\^9 per L, unless there is bone marrow involvement.

   Exclusion Criteria:

   Participants must not:
6. Have received treatment within the last 30 days with a drug (not including enzastaurin) that has not received regulatory approval for any indication at the time of study entry.
7. Are receiving concurrent administration of any other systemic anticancer therapy.
8. Are pregnant or breastfeeding.
9. Are unable to swallow tablets.
10. Are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin at least 14 days prior to study enrollment.
Heat Wrap Device Safety With Age and Body Fat

This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.

Safety measurements

Eligibility Criteria:
Inclusion Criteria:

* Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2
* or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or \< 30 kg/m2
* Females who are not pregnant or breastfeeding
* Subject is medically cleared for study participation

Exclusion Criteria:

* No sensitivity or allergy to device components in contact with skin
* Diabetes
* Any active skin disease or tattoos at the test site that would affect participation
Long-Term Study of Safety and Efficacy of WelChol® as an Additional Therapy in Patients With Type 2 Diabetes

This extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (WelChol®) in patients with type 2 diabetes.


Eligibility Criteria:
Inclusion/Rollover Criteria:

* Patients who have completed studies WEL-301, WEL-302, or WEL-303 with treatment compliance at least 80%
* Patients who have completed studies WEL-301, WEL-302, or WEL-303 who have not met withdrawal criteria
Tactile Imaging and Electromyography

Urinary incontinence (UI) and overactive bladder (OAB) in women has high prevalence which is increasing with the age. In adults aged 40 and older in the US demonstrated prevalence rate of 27.2% among man and 43.1% among women, respectively. Urine Incontinence was reported to affect 15% of women ages 40 to 49, 25% ages 60 to 69, and 38% of women age 80 and older.

Pelvic floor disorders result from neuro-urinary pathology as well as muscle functional impairment due to changes in bio-mechanical properties of soft tissues with the age. That is why pelvic floor characterization and diagnosis must include electomyographic (EMG) and biomechanical measurements (pressure) or better if EMG and tactile imaging with improved spatial resolution. The quantitative and objective imaging data for pelvic floor conditions could allow an effective treatment of OAB and UI.

In this research the investigators propose to develop a new device for accurate diagnosis of the diseased conditions by measuring the pelvic floor muscles strength and EMG activity. The value to society is high given by the prevalence of OAB and UI.

Eligibility Criteria:
Inclusion Criteria:

* Women above age of 21 with normal pelvic floor condition for the control
* Women with SUI conditions as defined by International Continence Society guidelines
* Women with OAB conditions as defined by American Urological Association and Society of Urodinamics, Female Pelvic Medicine \& Urogenital Reconstruction.

Exclusion Criteria:

* Any prior pelvic floor surgery related to SUI, POP or OAB conditions
* Active skin infection or ulceration within the vagina
* Presence of the vaginal septum
* Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder
* Ongoing radiation therapy for pelvic cancer; impacted stool
* Surgically absent rectum or bladder
* Sever hemorrhoids
* Significant circulatory or cardiac conditions that could cause excessive risk
* Significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia.
The Effect of Prolonged Inspiratory Time on Gas Exchange During Robot-assisted Laparoscopic Surgery With Steep Trendelenburg Position : A Crossover Randomized Clinical Trial

Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic pressure and absorbed carbon dioxide (CO2) gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time may improve the gas exchange during robot-assisted laparoscopic urologic surgery.

Gas exchange disturbance frequently occurs in steep Trendelenburg position during robot-assisted laparoscopic prostatectomy or cystectomy. Due to increased intrathoracic pressure and absorbed CO2 gas insufflated into abdominal cavity, hypercapnia as well as hypoxia may occur. Inverse ratio ventilation or prolonged inspiratory time during mechanical ventilation has been reported to be improve gas exchange in adult respiratory distress syndrome. The investigators attempt to test the hypothesis that prolonged inspiratory time (I:E ratio = 1:1) may improve the gas exchange during robot-assisted laparoscopic urologic surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status class I-II and scheduled for an elective robot-assisted laparoscopic radical prostatectomy or robot-assisted laparoscopic radical cystectomy
* Patients who voluntarily decides to participate in the trial and has agreed in written informed consent

Exclusion Criteria:

* Patients with the anatomical abnormalities of respiratory system(abnormal airway anatomy, severe scoliosis, post-pneumonectomy state), severe chronic respiratory diseases, chronic obstructive pulmonary disease (COPD), asthma, heart failure, obesity ( Body Mass Index \[BMI\] \> 30kg/m2), severe hepatic failure or renal failure
Investigating Hearing Aid Frequency Response Curves

Internal research on the manufacturer's hearing aid products has idenitfied areas in which the investigators can improve the hearing aid frequency response curve. This study aims to investigate the current freqeuncy response curve in the manufacturer's products to variations of these curves to determine if hearing aid users prefer the variations over the manufacturer's standard curve.

Internal testing has identified areas in which the investigators can improve the performance of the manufacturer's hearing aid products. This should potentially lead to increased hearing aid user satisfaction due to an improvement in sound quality. However, the investigators are currently unsure if implementing these new frequency response curves will be preferred by the manufacturer's clients. Therefore, a study is proposed in which hearing aid users will compare the manufacturer's current frequency response curve to variations made to the curve and determine which one they prefer while listening to live speech/music or while streaming speech/music.

Eligibility Criteria:
Inclusion Criteria:

* N2 - N4 Hearing losses
* Health Outer ear
* no visible congenital or traumatic deformity of the outer ear
* Symmetrical hearing loss - no air-bone gap greater than 10 dB at all 500, 1000, 2000, and 4000 Hz.
* Ability to answer questions and repeat sentences
* No history of problematic tinnitus or pain/discomfort from loud sounds
* No history of active drainage from the ears in the past 90 daysInformed consent as documented by signature
* Willingness to wear different styles of couplings
* Willingness to wear binaural fitting
* Experienced Users = more than 3 months of hearing aid experience. If not more than 3 months, they will be considered a new user (Experience will not exclude them from study, only will be used to categorize them)
* Ability to travel throughout facility

Exclusion Criteria:

* Contraindications to the medical device (MD) in this study (e.g. known hypersensitivity or allergy to the investigational products)
* Limited mobility/not able to come to the scheduled visit
* Inability to produce reliable hearing test results
* History of active drainage from the ear in the previous 90 days
* Abnormal appearance of the eardrum and ear canal.
Pediatric Open-Label Extension Study

This is an open-label, 104-week, multicenter, extension study designed to evaluate the long-term safety, tolerability and effectiveness of flexibly dosed lurasidone (20, 40, 60 or 80 mg/day) in pediatric subjects who have completed the 6-week treatment period in the preceding studies, D1050301, D1050325, and D1050326


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from parent(s) or legal guardian(s) with sufficient intellectual capacity to understand the study and support subjects' participation in the study procedures must be obtained for subjects who are not emancipated. In accordance with Institutional Review Board (IRB) or Independent Ethics Committee (IEC) requirements, the subject will complete an informed assent when developmentally appropriate, to participate in the study before conduct of any study-specific procedures.
* Subject has completed Study D1050301 (Visit 9) OR
* Subject has completed Study D1050325 (Visit 9) OR
* Subject has completed Study D1050326 (Visit 8)
* Subject is judged by the investigator to be appropriate for participation in a 104-week clinical trial in an outpatient setting involving open-label lurasidone treatment, and is able to comply with the protocol.
* A reliable informant (eg, parent, legal guardian, or caregiver) must be available to accompany the subject at each visit. For subjects entering from Study D1050325, the reliable caregiver must also oversee the administration of the study drug throughout the study
* Females who participate in this study:

  * are unable to become pregnant (eg, premenarchal, surgically sterile, etc.) -OR-
  * practices true abstinence (consistent with lifestyle) and must agree to remain abstinent from signing informed consent to at least 7 days after the last dose of study drug has been taken; -OR-
  * are sexually active and willing to use a medically effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.
* Males must be willing to remain sexually abstinent (consistent with lifestyle) or use an effective method of birth control (eg, male using condom and female using condom, diaphragm, contraceptive sponge, spermicide, contraceptive pill, or intrauterine device) from signing informed consent to at least 7 days after the last dose of study drug has been taken.

Exclusion Criteria:

* Subject is considered by the investigator to be at imminent risk of suicide.
* Exhibits evidence of moderate or severe extrapyramidal symptoms, dystonia, tardive dyskinesia, or any other moderate or severe movement disorder. Severity to be determined by the investigator.
Study to Assess Relative Bioavailability of BMS-986435 Formulations in Healthy Adult Participants

The purpose of this study is to assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female participants.


Eligibility Criteria:
Inclusion Criteria:

* Body weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m\^2, inclusive.
* Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
* Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.

Exclusion Criteria:

* Any acute or chronic medical illness.
* History of heart disease.
* Prior exposure to BMS-986435.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Iltamiocel Compared to Placebo for Chronic Fecal Incontinence in Females With Obstetric Injury

This study evaluates the efficacy and safety of a single injection of iltamiocel (300 x 10\^6 cells) compared to a placebo in the reduction of fecal incontinence episode frequency in adult female participants with chronic fecal incontinence and a history of obstetric anal sphincter injury. Half of the participants will receive iltamiocel (injections with cells) and the other half will receive placebo.

Chronic fecal incontinence (FI) is the recurrent unintended passage of mucus and/or liquid or solid stool for at least 6 months. Iltamiocel is an investigational cell therapy product that involves a medical procedure in which a participant's own muscle cells are collected, processed, and then injected into the tissues of the external anal sphincter.

This is a double-blind randomized study, which means neither the participant, nor the study doctor will know which treatment group the participant will be in. Participants who are randomly chosen to receive injection with placebo will have the option to receive an injection with their cells after completion of the blinded portion of their study participation (12 months).

Eligibility Criteria:
Inclusion Criteria:

* Adult female ≥ 18 years of age who has primary symptoms of fecal incontinence (FI) for at least 12 months.
* History of obstetric anal sphincter injury (e.g., episiotomy, perineal tear).
* Failed conservative treatment (e.g., dietary modification, antidiarrheal medications, pelvic floor muscle training, biofeedback) for at least 6 months prior to enrollment.
* Must be willing and able to comply with the study procedures, be mentally competent and able to understand all study requirements, and must agree to read and sign the informed consent form prior to any study-related procedures.

Exclusion Criteria:

* Has an implanted stimulation neuromodulation system (sacral or tibial) and symptoms are unstable as determined by the physician.
* Is pregnant or planning to become pregnant within the next 2 years.
* Has known rectal sensory dysfunction (e.g., hypersensitivity or hyposensitivity).
* Has an obstetric anal sphincter injury (e.g., episiotomy, perineal tear) within 1 year previous to study enrollment.
* Patient BMI ≥ 38.
* Has a history of cancer in the colorectal or pelvic organs within 5 years prior to study enrollment.
* Any cancer that has undergone treatment within the past 12 months.
* Has an established diagnosis of inflammatory bowel disease (Crohn's disease, ulcerative colitis) or current intestinal stoma.
* Has grade III/IV hemorrhoids.
* Has chronic diarrhea at the time of Screening.
* Has chronic constipation at the time of Screening.
* Has significant pelvic floor prolapse, significant genitourinary prolapse beyond the introitus, significant symptomatic rectocele, or evidence of significant rectal evacuation disorder leading to post-defecatory leakage.
Iodine I 131 Ethiodized Oil in Preventing Recurrent Cancer in Patients Who Have Undergone Treatment for Liver Cancer

RATIONALE: Iodine I 131 ethiodized oil may help prevent or delay the recurrence of cancer. It is not yet known whether iodine I 131 ethiodized oil is more effective than non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.

PURPOSE: This randomized phase III trial is studying iodine I 131 ethiodized oil to see how well it works compared with non-radiolabeled ethiodized oil in preventing recurrent cancer in patients who have undergone treatment for liver cancer.

OBJECTIVES:

Primary

* Determine whether treatment with adjuvant intra-arterial iodine I 131 ethiodized oil reduces the percentage of tumor recurrence in patients with curatively treated hepatocellular carcinoma.

Secondary

* Evaluate the overall and recurrence-free survival of these patients.
* Evaluate the deterioration of liver function in these patients.
* Evaluate the toxicity of intra-arterial iodine I 131 ethiodized oil in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive an intra-arterial infusion of iodine I 131 ethiodized oil.
* Arm II: Patients receive an intra-arterial infusion of unlabeled ethiodized oil.

After completion of study treatment, patients are followed periodically for 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of hepatocellular carcinoma (HCC)

  * Alpha-fetoprotein \< 20 ng/mL
* Must have undergone curative treatment for HCC within the past 8-20 weeks, including 1 of the following:

  * Curative resection
  * Alcohol ablation, radiofrequency ablation, or cryotherapy (for 1 or 2 nodules \< 5 cm in diameter)
* No ascites
* No other intrahepatic involvement or nodule progression as assessed by ultrasound
* No extrahepatic metastases

PATIENT CHARACTERISTICS:

* WHO performance status 0-2
* ANC ≥ 1,500/mm³
* Platelet count ≥ 50,000/mm³
* Bilirubin ≤ 51 μmol/L
* Creatinine ≤ 120 μmol/L
* Not pregnant or nursing
* Negative pregnancy test
* Child-Pugh score \< 8 (class B)
* No decompensated cirrhosis
* No encephalopathy
* No uncontrolled bleeding
* No portal thrombosis, right- or left-branch thrombosis, extrahepatic thrombosis, or portal reflux by doppler or CT scan
* No unstable medical or surgical disease
* No contraindication to vascular arteriography
* No history of complications after injection of iodine contrast agents
* Not incarcerated

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* Recovered from all prior therapy
* No prior hormonal treatment, including tamoxifen and somatostatin analogs
* No prior systemic chemotherapy
Anxiety Treatment Inspired by Dialectical Behavior Therapy (DBT)

The main interest in this study is to investigate if it is possible to use strategies from Dialectical Behavior Therapy (DBT) to increase effectiveness of ordinary Cognitive Behavioral Therapy (CBT) for patients with anxiety disorders. For the patients included in this study, previous exposure-based treatment should have been unsuccessful (drop-out, relapse or lack of positive results after treatment).


Eligibility Criteria:
Inclusion Criteria:

* Currently diagnosed with an anxiety disorder. To be included, the level of anxiety in a critical situation should be high and of a more acute type, unlike the lower more generalized anxiety in for example generalized anxiety disorder.
* Previous exposure-based treatment should have been unsuccessful (drop-out, relapse or lack of positive results after treatment).

Exclusion Criteria:

* Severe depression.
* Psychotic disorder.
* A documented neuropsychiatric diagnosis.
Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients

The consequences of COVID-19 in these already fragile patients should be evaluated. It will be important to appreciate the confinement consequences imposed on the patient on the course and impact of the disease.

These consequences can be assessed by the end of confinement and 6 months after the latter is lifted.

Adaptation capacities are necessary to cope with the brutal and drastic changes imposed by the pandemic and its consequences. In Parkinson's disease, where there are routine situations with difficulties adjusting to newness, patients in the current situation may be particularly affected and present anxiety due to great difficulties in adaptation.

The repercussions in terms of symptoms (motor and non-motor) of the disease could be very significant. In this population already widely exposed to anxio-depressive symptoms (depression being a common symptom of Parkinson's disease, affecting up to 30 to 40% of patients outside of crisis periods), we can expect a risk increased psychiatric decompensation. The psychiatric consequences could not be limited to the current period but also concern long-term patients, in particular if there is decompensation of other symptoms of the disease (motors, complications linked to treatment, etc.).

The consequences of COVID-19 in these already fragile patients should be evaluated. It will be important to appreciate the confinement consequences imposed on the patient on the course and impact of the disease.

These consequences can be assessed by the end of confinement and 6 months after the latter is lifted.

This is an observational, French multicenter study, of an uncontrolled cohort of parkinsonian patients followed by doctors from Parkinson Expert Centers in hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Patient followed by a doctor from the Parkinson Expert Center of the Toulouse University Hospital, Lille, Paris, Rouen, Nimes, Reims, Besancon, Marseille
* And with idiopathic Parkinson's disease
* Patients hospitalized or in consultation between 16/03/2020 and 16/05/2020.

Exclusion Criteria:

* Atypical parkinsonian syndrome
* Patient subject to a legal protection order (tutorship)
* Patient not wishing to answer questions