cyrilzakka/clinical-trials huggingface dataset:
Eccentric Cycling Exercise on Mitochondrial Function of Lymphocyte

Eccentric cycling exercise (ECE) features lower metabolic demand and higher improvement of muscle strength compared to traditional concentric cycling exercise (CCE). Mitochondria can regulate energy metabolism and adaptive immune quality in T lymphocytes. However, the effects of ECE on mitochondrial functions in T-lymphocytes have not yet been established.

Method: A total of 33 healthy sedentary males were randomized and divided into ECE (n=11), CCE (n=11), and control groups (n=11). These subjects progressively performed CCE or ECE from 60% to 80% maximal workload on a bicycle ergometer for 40 min/day, 5 days/week for 6 weeks. A graded exercise testing and an isokinetic strength test were conducted to evaluate cardiopulmonary fitness and muscle strength, respectively. Phenotypes and mitochondrial respiratory capacity in T lymphocyte were analyzed using flow cytometry and high-resolution respirometer, respectively.

Eccentric exercise training (EET) increases physical performance while having lower metabolic demand than concentric exercise training (CET).

Mitochondria of lymphocytes are essential for cell proliferation, death, and differentiation, and play a critical role in establishing lymphocyte phenotypes and their functions.

Whether EET influences lymphocyte bioenergetic efficiency remains unclear. The study was to investigate the effects of ECE and CCE regimens on adaptive immune functions and mitochondrial bioenergetics of T lymphocytes in sedentary males.

Eligibility Criteria:
Inclusion Criteria:

1. Sedentary lifestyle.
2. Nonsmokers, nonusers of medications/vitamins.
3. No any cardiopulmonary/hematological risks.

Exclusion Criteria:

1. Have regular exercise habits (i.e., exercise frequency once per week, duration \>20 min).
2. Have retabolic or musculoskeletal disease.
Transversus Abdominis Plane(TAP) Block, Local Infiltration and Intravenous Dexketoprofen in Inguinal Hernia Repair

This study evaluates the compare the effects of ultrasound guided TAP block, local anesthetic infiltration to the incision line and intravenous dexketoprofen on postoperative analgesic efficacy and rescue tramadol consumption in inguinal hernia repairs.

Currently, multimodal techniques are used in inguinal hernia repairs in addition to pharmacological and regional techniques for postoperative analgesia.TAP block is performed on the principle of hydrodissection of the fascia between the internal oblique and transversus abdominis muscles of the abdominal wall muscles with local anesthetic drugs. Local anesthetic drugs provide analgesic effect up to 24 hours in the postoperative period by blocking the T6-L1 nerves in the facial plane. Local anesthetic infiltration which is one of the regional anesthetic techniques, is another method of postoperative analgesia. intravenous analgesic drug is also used as pharmacological postoperative analgesia method in most clinics.

Eligibility Criteria:
Inclusion Criteria:

* Subject who aged 18-75 years
* American Society of Anesthesiologist (ASA) I-III
* Subject undergoing unilateral or bilateral inguinal hernia repair

Exclusion Criteria:

* Subject under 18 and over 75 years of age
* ASA IV
* History of allergy to agents
* Analgesic drug use in the last 48 hours
* Morbid obese (BMI\> 35)
* Confusion
* Coagulopathy
* Local infection at the injection site
* Subject with heart, lung, hematologic, metabolic and endocrine disease
* Subject who did not want to be included in the study
* Subject who refused the spinal anesthesia
* Subject who failed the spinal anesthesia
Supportive Programs for Supporting Optimal Recovery in Participants Undergoing Gynecological Surgery

This trial studies how well two different supportive programs work in supporting optimal recovery in participants undergoing gynecological surgery. Supportive programs use different methods for helping participants cope with the surgical experience including gentle movements, counseling, writing, or relaxation techniques, and may help improve participants' well-being after gynecological surgery.

PRIMARY OBJECTIVES:

I. To calculate recruitment, adherence, assessment completion, and retention rates.

SECONDARY OBJECTIVES:

I. Document the frequency of adverse events. II. Assess descriptive data on proposed outcomes (i.e., pain, sleep disturbances, psychological distress) for the next phase of study.) III. Qualitatively assess acceptability to guide future study planning.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (MINDFUL MOVEMENT AND BREATHING \[eMMB\]): Participants will receive instruction on awareness meditation, breathing and relaxation, and awareness meditation. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants will also be given a self-directed video to be used before surgery and daily for two weeks following surgery.

GROUP II (ATTENTION CONTROL \[AC\]): Participants will receive caring attention. This will include a call with the interventionist to invite participants to initiate additional guidance upon request prior to surgery and a meeting by videoconferencing the day following surgery. Participants are also asked to write brief diary entries once before surgery and daily for two weeks following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an abdominal gynecological surgery (i.e. uterine, ovarian) to remove a suspected malignancy.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1.
* Cognitively able to complete assessments as judged by the study team.
* Able to understand, read and write English.

Exclusion Criteria:

* Have schizophrenia or any other psychotic disorder.
* Have a diagnosed sleep disorder including untreated obstructive sleep apnea, periodic limb movement disorder, or restless leg syndrome.
RCT Implant Based Breast Reconstruction

The main objective of this study is to evaluate patients undergoing mastectomy with immediate implant-based breast reconstruction and compare the outcomes of patients who are discharged the day of surgery versus patients who are discharged on post-operative day one. The primary aim of the study will be to compare the postoperative outcomes and complications between the two study groups within 30 days of discharge. The secondary aims of the study will be to compare patient satisfaction, quality of life and discharge perceptions.

Traditionally patients undergoing mastectomy with immediate implant-based breast reconstruction were admitted to the hospital overnight. However, recent retrospective studies utilizing ERAS protocols have reported same day discharge as a possibility for this patient population. ERAS protocols for breast cancer surgery and reconstruction are becoming more popular. This along with the increasing utilization of prepectoral breast reconstruction that is associated with less postoperative pain and opioid use, are promising avenues to decrease the need for overnight hospital stay. If it can be shown that discharge on the same day of surgery does not pose any major risks compared to discharge on post-operative day one, there is the potential to decrease length of hospital stay, improve hospital capacity and dramatically decrease costs.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who will undergo immediate, (unilateral or bilateral)implant-based breast reconstruction following mastectomy for breast cancer or prophylaxis at the University of Colorado Anschutz Medical Campus and Highlands Ranch Campus.
2. Patients undergoing sub-pectoral and pre-pectoral breast implant reconstructive techniques will be both included.
3. All adult (\>18 years old), female patients who will undergo mastectomy for breast cancer or prophylaxis and immediate implant-based reconstruction who are able to complete surveys independently will be eligible for the study.
4. English and Spanish speaking
5. Patients will be included regardless of their current chemoradiation plan

Exclusion Criteria:

1. Age \> 80 years
2. ASA 4
3. suboxone use
4. documented substance use disorder as defined by the DSM-5 (I.e. alcohol use disorder, opioid use disodrer, cocaine use disorder, etc). Marijuana use will not be considered a substance use disorder
5. OSA requiring CPAP
6. recent pneumonia (within 6 weeks)
7. BMI \> 45 kg/m2 with any co-morbid condition that is not well controlled
8. poorly controlled diabetes (HgbA1c \> 9)
9. Not English or Spanish speaking
Post Market Clinical Follow-Up Study for EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur

MicroPort (MPO) is conducting this PMCF study to evaluate the safety and effectiveness of its EVOLUTION® BIOFOAM® Tibia and EVOLUTION® Cruciate Sacrificing/Cruciate Retaining (CS/CR) Porous Femur components, including EVOLUTION® CS tibial inserts. This type of study is required by regulatory authorities for all devices that have been approved in Europe to evaluate the medium and long-term clinical evidence.

The objectives of this study are:

1. To estimate the individual component survivorship of EVOLUTION® BIOFOAM® Tibia and EVOLUTION® CS/CR Porous Femur components, including EVOLUTION® CS tibial inserts
2. To find out the cumulative incidence of component revision of each component in this combination.
3. To find out the functional outcome scores at early, midterm, and long term follow-up.

Eligibility Criteria:
Inclusion Criteria:

1. Has previously undergone or currently has determined to undergo a primary TKA with the specified combination of components: EVOLUTION® CS/CR Porous Femur, EVOLUTION® CS Tibial Insert, and EVOLUTION® BIOFOAM® Tibia and modular keel
2. Has previously undergone or currently has determined to undergo a primary TKA for any of the following:

   * non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
   * inflammatory degenerative joint disease including rheumatoid arthritis;
   * correction of functional deformity;
   * willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit.
3. Previously implanted subjects must be enrolled within 3 years (+6 months) of their primary TKA implantation

Exclusion Criteria:

1. Skeletally immature (less than 21 years of age) at time of implantation
2. Has or had an overt infection at the time of implantation
3. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
4. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
5. Has or had inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
6. Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
7. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
8. Unwilling or unable to sign the Informed Consent document
9. Has documented substance abuse issues
10. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
11. Currently incarcerated or has impending incarceration
12. Has a medical condition, as judged by the Investigator, that would interfere with the subject's ability to comply with the requirements of the protocol
Psychiatric Future of Young Patients Hospitalized in the Pass'Aje Service Between 2006 and 2010

The emergence of adult psychic disorders occurs in about three quarters of cases before 25 years. The Pass-Aje service of Clermont-Ferrand University Hospital is a psychiatric unit specializing in the management of disorders of young adults. This unit evaluates the first episodes among the diversity of the clinical presentations of the psychic disorders. Suicidal attempts or ideations account for a large part of the reasons for entering the unit and are found transversely in many disorders. Among the reasons for hospitalization are a wide variety of situations that are not initially associated with an accurate diagnosis such as withdrawal, de-schooling, runaways, behavioral disorders (disorders of social interactions, self and hetero aggression, eating disorders).

Investigator propose to study the psychiatric outcome of hospitalized patients in the Pass-Aje unit and their psychosocial evolution in order to compare them with the data of the general population and to identify the factors influencing their future.

Former young psychiatric patients hospitalized in the Pass'Aje units are contacted by phone several years later to determine their psychiatric outcome.

Eligibility Criteria:
Inclusion Criteria:

* all patients hospitalized in the Pass'Aje unit between 2006 and 2010
* Aged from 16 to 25 years when hospitalized

Exclusion Criteria:

* Patient refusing or not understanding the purpose of the study.
* Patients who died.
* Patient phone number unavailable or non-functional
Anterior Segment Changes After Phacoemulsification in Cataractous Eyes with Shallow Anterior Chamber

Phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. Limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps

Phacoemulsification in shallow anterior chamber is considered to be more hazardous regarding risk of intraoperative and postoperative complications. Limited anterior pars plana vitrectomy can be combined with phacoemulsification to deepen the anterior chamber and facilitate surgical steps. This study aimed to compare the efficacy of combined phacoemulsification with limited pars plana vitrectomy versus phacoemulsification alone in cases with shallow anterior chamber.

Methods: 24 eyes were operated on and divided into two groups. Twelve eyes underwent combined approach and the other 12 eyes have undergone phacoemulsification only.

Eligibility Criteria:
Inclusion criteria:

* Anterior chamber depth of less than 2.8 mm associated with cataract

Exclusion Criteria:

* Mature cataract
* History of previous ocular surgery
* Posterior segment pathology
A Study of CM310 in Subjects With Chronic Pruritus

This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM310 in subjects with chronic pruritus of unknown origin.

The study consists of a Screening Period (up to 4 weeks), Treatment Period (16 weeks) and Safety Follow-up Period (8 weeks).

50 subjects who meet eligibility criteria will be randomized 1:1 to receive either CM310 300 mg or matched placebo subcutaneously every two weeks (Q2W) for a total of 8 times. All subjects will receive mometasone furoate nasal spray (MFNS) on a daily basis as a background treatment throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old.
* With chronic pruritus of unknown origin.
* With the worst pruritus numerical rating scale (WI-NRS) ≥7.
* Contraception.

Exclusion Criteria:

* Heavy drinking in the 3 months prior to screening.
* With severe hepatic and renal impairment.
* Previous history of autosensitivity dermatitis.
* Allergic to CM310/placebo.
* Vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.
CAncer TReatment INformed by the Molecular Tumor Board At Dartmouth

This is a single-arm Phase II study to measure the impact of Molecular Tumor Board treatment recommendations on treatment decision-making in clinical practice at the Dartmouth Cancer Center. Following tumor genetic profiling, subjects will be screened for eligibility. Eligible subjects' cases will be evaluated by the Dartmouth Cancer Center Molecular Tumor Board, and treatment recommendations will be entered into the medical record as per standard procedure.

The primary endpoint is a survey response from the treating physician indicating how Molecular Tumor Board evaluation impacted treatment decisions. Secondary endpoints include: 1) Molecular Tumor Board treatment recommendation; 2) disease progression on line of therapy started after MTB recommendations were made. Surveys will be administered approximately 3 and 12 months after Molecular Tumor Board recommendations are made.


Eligibility Criteria:
Inclusion Criteria:

* Subject must provide verbal informed consent for study participation prior to MTB case evaluation.
* Tumor genetic profiling performed as standard of care must include ≥100 genes.
* Tumor must contain at least one of the following genetic alterations: (A) an alteration known to be potentially associated with sensitization to a clinically available treatment. (the list of genetic alterations evolves as new information emerges and new drugs are developed); (B) an alteration suspected to be germline.
* Subject must have ECOG Performance Status of 0 to 2.
* Subject must have measurable or evaluable disease.
* Subjects who have previously enrolled in this study can be enrolled a second time if they undergo genetic profiling of a tumor that was biopsied/sampled AFTER progression on an intervening line of treatment started after the time of first enrollment. Re-enrollment of such subjects must be noted in REDCap to facilitate longitudinal analysis.
* Age ≥18 years.

Exclusion Criteria:

* Subjects with a tumor harboring a genetic alteration for which an FDA-approved drug is indicated that the patient has not yet received (example for exclusion: a melanoma with a BRAF-V600E mutation in a subject who has not yet been treated with a BRAF inhibitor).
* Pregnant women.
Characterization of Aortic Tissue at Reoperation

This study will analyse factors contributing to cardiac re-operation to determine causative effects

This study will collect clinical data on the characteristics of aortic tissue on which BioGlue has been applied during a previous cardiovascular surgery. This is a post market surveillance study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing an aortic re-operation
* Subject has had BioGlue used during previous aortic surgery
* Subject is willing and able to give written informed consent for participation

Exclusion Criteria:

* Subject with a history of vasculitis
* Subject with active infection (endocarditis)
* Subject with a history of chronic inflammatory condition which may have led to ongoing tissue damage
* Subject with a history of auto immune disease
Desiccated Thyroid Extract and Levothyroxine for Hypothyroidism Treatment

Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an improvement of cognitive function, and an increase in sense of well-being/ quality of life equivalently compared with L-T4.


Eligibility Criteria:
Inclusion Criteria:

* Patients will be between the ages of 18 to 65 and will have been on levothyroxine for primary hypothyroidism for at least 6 months.

Exclusion Criteria:

* Patients will be excluded if they have the following problems: pregnancy, plan for pregnancy in the next 12 months, cardiac disease, especially coronary artery disease, chronic obstructive lung disease, malabsorption disorder, gastrointestinal surgeries, significant renal or liver dysfunction, seizure disorders, thyroid and non-thyroid active cancers, uncontrolled psychosis, psychotropic medication use, steroid use, amiodarone, chemotherapy for cancer, iron supplement more than 325mg per day, carafate/ proton pump inhibitor use, cholestyramine use, and those with recent PCS orders who are expected to move out of the geographic area, age less than 18 years old or older than 65 years old.
* Patients scheduled for deployment will be excluded.
Galvus on Met Phase 4 Study : Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin in Patients With Type 2 Diabetes Mellitus

The study design of this trial is open-label, randomized, multi-center, parallel-group study.

* The progressive nature of T2DM will require the use of combination therapy in many patients over time to achieve and maintain glycemic control. Early combination, compared with maximal dose of monotherapy, could be more effective in lowering glycemia with better tolerability.
* Vildagliptin is a new oral antidiabetic drug acting as a potent and selective inhibitor of dipeptidyl peptidase-4(DPP-4), the enzyme responsible for the rapid degradation of circulating glucagon-like peptide-1. Vildagliptin improves islet function by a mechanism of increasing plasma levels of the active forms of the incretin hormones, GLP-1 and GIP.
* Metformin improves hyperglycemia primarily through its suppression of hepatic gluconeogenesis as well as enhancement of peripheral glucose update. Metformin is the most commonly prescribed first-line antidiabetic drug worldwide, but due to the progressive worsening of blood glucose control during the natural history of type 2 diabetes, combination therapy usually becomes necessary.
* Thus their combination therapy with complimentary action mechanism could be as effective as up titration of monotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 Diabetes Mellitus who were inadequately controlled (baseline A1c of 7.0\~11.0%)on metformin monotherapy (1500mg metformin)for ≥ 2 months before baseline visit
* Age of 18-80 years
* Body Mass Index of 18-40 kg/m2

Exclusion Criteria:

* Type 1 of diabetes
* Myocardial Infarction, Unstable Angina, or Coronary Artery Bypass Graft within the previous 6 months
* Congestive Heart Failure (III or NYHA class IV)
* Liver disease such as cirrhosis or Chronic Active Hepatitis
* History of Lacticacidemia
* Use of any Oral Anti-diabetic Drug other than Metformin within the 2 months
* Use of insulin before screening visit
* ALT or AST \>3 times the upper limit of Normal range
* Creatinine \>1.5 mg/dl
* Other situation (pregnant or lactating females, history of drug or alcohol abuse, night-shift workers, clinically significant laboratory abnormality on screening or any medical condition that would affect the completion or outcome of the study)