cyrilzakka/clinical-trials huggingface dataset:
Sleep Quality Response to Resisted Training After Coronary Artery Bypass Grafting

Background:There are still many gaps in research concerning the effect of different physical training modalities on sleep quality in the population underwent coronary artery bypass graft surgeries(CABG).Purpose:The present study was conducted to compare the quality of sleep in subjects who underwent CABG, were submitted to two types of training (i.e, aerobic exercise alone or combined aerobic and resistance training

OBJECTIVE/BACKGROUND:

There are still many gaps in research concerning the effect of different physical training modalities on sleep quality in the cardiac population. Thus, the objective of the present study was to compare the quality of sleep in subjects who underwent coronary artery bypass surgery submitted to two types of training (ie, aerobic exercise alone or combined aerobic and resistance training).

PATIENTS/METHODS:

80 Participants aged 45-65 years were randomized to two groups: aerobic group (AG), combined aerobic and resistance group (ARG). Training lasted ten consecutive weeks with 30 uninterrupted sessions. The actigraph (Actiwatch Minimitter Company, Incorporated (INC) - Sunriver, OR, USA) was placed on the non-dominant wrist and activities were monitored continuously while being recorded at one minute intervals. The participants kept the device for a period of 96 hours before the first and last training sessions.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who have underwent CABG surgery since 6-8 weeks
2. Their ages ranges from 40 and 80 years of age
3. Medically stable patients.
4. patients did CABG-only treatment (not combined with valve replacement surgery)
5. Current complaint of poor Sleep quality (SQ) (score \> 5 of the SQ scale)
6. Body mass index ≤ 35 kg/m2 (no obstructive sleep apnea)

Exclusion Criteria:

1. Any patient is known to have any unstable medical condition
2. History of chronic insomnia for at least one year before surgery
3. Indication of receiving treatments for depression and anxiety
4. Musculoskeletal or neurological conditions that might interfere with the execution or the assessment of the exercise.
Effect of Hyperoxia and Hypergravity on Lung Ventilation and Perfusion

The primary aim of this project is to get further knowledge on the effects of + Gz accelerations and hyperoxia on lung ventilation in humans. The secondary aim is to study lung perfusion and cardiovascular function in these conditions.

Experiments were conducted in a human centrifuge. The protocol aimed at mimicking a routine peacetime flight in combat aircraft, and included 10-min exposure to +1.4 - +3.5 Gz. Subjects were exposed three times to this sequence, breathing air, 44.5% O2 or 100% O2.

Ten volunteers wearing anti-G trousers participated in the study. The Ethics Committee Ile-de-France III and the French National Agency for Drug Safety (ANSM) approved the protocol (number 2009-A01092-55).

Three different imaging techniques, electrical impedance tomography (EIT), pulmonary ultrasound and chest SPECT/CT were used and compared. EIT enabled ventilation monitoring in the human centrifuge, whereas pulmonary ultrasound and SPECT/CT gave functional and topographical information before and after exposure to +Gz accelerations. EIT analysis focused on regional ventilation, SPECT on global lung ventilation and perfusion, CT on the presence of atelectasis, and pulmonary ultrasound analysis looked for comet tails in 64 chest areas. Arterial blood pressure was recorded continuously by finger photoplethysmography. Cardiac output and stroke volume were computed from these recordings, using three different algorithms. Echocardiography was used as reference non-invasive technique for stroke volume determination and performed before and after exposure to +Gz accelerations.

Eligibility Criteria:
Inclusion Criteria:

* normal lung function checked by pulmonary function tests

Part 1 exclusion Criteria:

* past medical history of heart or lung disease
* current medical treatment for heart or lung disease
* smoking
* bad tolerance to +Gz accelerations (G-induced loss of consciousness, motion sickness)

Part 2 exclusion criteria:

* past medical history of heart or lung disease
* current medical treatment for heart or lung disease
* smoking
* The use of medication for hypertension
* asymmetric values of left/right humeral arterial blood pressure
* significant echocardiographic abnormalities or bad echogenicity
* bad tolerance to +Gz accelerations (G-induced loss of consciousness, motion sickness)
A Study of MEDI-575 in Patients With Advanced Solid Malignancies

The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).


Eligibility Criteria:
Inclusion Criteria:

* Having advanced solid malignancy for which no curative or standard therapies exist
* Karnofsky performance status of ≥60
* Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part)

Exclusion Criteria:

* Inadequate bone marrow reserve or organ function
* Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-575. Patients must have no unhealed wounds or unhealed fractures
* History of allergy or reaction to any component of the MEDI-575 and/or monoclonal antibody
Sudapyridine (WX-081) in Healthy Volunteers

The objective of this study is to evaluate the safety, tolerability as well as pharmacokinetics of Sudapyridine (WX-081) in Chinese volunteers.

In this study, a single-center, randomized, double-blind, placebo-controlled, dose-ascending design was used to evaluate the safety, tolerability and pharmacokinetic characteristics of Sudapyridine (WX-081) tablets in healthy Chinese subjects using placebo as control.

This study was divided into two stages. The first stage evaluated the tolerance of single administration, pharmacokinetic characteristics, and the effect of food on PK. The second stage evaluated the tolerance of multiple administration and PK characteristics.

Eligibility Criteria:
Inclusion Criteria:

* Weight: ≥50 kg; 19≤ body mass index (BMI) \< 26 kg/m2;
* Considered healthy by the investigator based on a detailed history, thorough physical examination, clinical laboratory examination, 12-lead ECG, and vital signs results;
* No parenting plan and reliable contraception during the trial period and within 3 months after the last dose.

Exclusion Criteria:

* Allergic to any drug of the same category or its ingredients;
* A history of alcohol dependence or drug abuse;
* Laboratory obvious abnormalities;
* CYP3A4 potent inducer or inhibitor had been taken within 30 days prior to enrollment;
* Any serious cardiovascular, kidney, liver, blood, tumor, endocrine and metabolic, autoimmune or rheumatic diseases.
Effect of RIC on Cerebral Autoregulation in Patients Undergoing Cerebrovascular Stent Implantation

The purpose of this study is to determine the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation.

In this study, 104 cases of patients with cerebrovascular stent implantation will be enrolled in the First Hospital of Jilin University, and they will be divided into the RIC group and the sham-RIC group. The RIC group received remote ischemic conditioning for 200mmHg, 2 times per day for 7 consecutive days or from enrollment to discharge. The sham-RIC group received remote ischemic conditioning for 60mmHg, 2 times per day for 7 consecutive days or from enrollment to discharge. Two groups will be followed up to evaluate the effect of remote ischemic conditioning on cerebral autoregulation in patients undergoing cerebrovascular stent implantation.

Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years, regardless of sex;
* Patients with symptomatic or asymptomatic cerebral vascular stenosis (including internal carotid artery system and vertebrobasilar system) who are candidates for elective cerebrovascular stenting.
* Patients or their immediate family members are able and willing to sign informed consent.

Exclusion Criteria:

* Patients with progressive stroke;
* mRS≥ 2 points before admission;
* Patients with other surgical treatments;
* Patients with other serious diseases or a life expectancy of less than 3 months
* Patients who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper extremities, venous thrombosis in the acute or subacute stage of upper extremities;
* Laboratory test indicators are unqualified: aspartate aminotransferase or alanine aminotransferase is 3 times higher than the upper limit of the normal range, blood creatinine \> 265umol/L (\>3mg/dl), platelet \< 100×109/L, international normalized ratio (INR), activated partial thromboplastin time (APTT), prothrombin time (PT) exceed the upper limit of the normal range;
* Pregnant or lactating women;
* Patients who are participating in other clinical studies, or who have participated in other clinical studies within 3 months prior to enrollment;
* Unwillingness to be followed up or poor adherence to treatment;
* Other circumstances that the investigator considers unsuitable for enrolment.
A Study of Long-Term Responders on Olaparib

This is an observational and sample collection study involving patients (alive or deceased) from several clinical trials who had received the investigational drug, olaparib in other research studies. There is no intervention given for this study.

This research is being done to understand of the mechanisms involved in patients whose cancer responds well and whose cancer does not respond well to investigational drug, olaparib, to help better understand how olaparib works and to better identify patients who may benefit from this therapy.

This is study will compare biomarker research with response in patients who have received olaparib.

Patients who have had a durable response to olaparib for at least 2 years will be approached for the study.

Patients who agree to this study will then have their medical history collected and will be asked to complete a questionnaire. Archival tumor tissue will also be collected for biomarker research.

A waiver of consent is requested to access the medical records and archival tumor tissue of patients who are deceased.

If participants are still taking olaparib, they will be asked to provide blood samples for pharmacokinetics and circulating tumor DNA, and the results of CT scans taken as part of their standard of care or as a part of another research study. If participants' disease worsens while still on olaparib, they will then be asked to provide a blood sample for pharmacogenomics and BRCA testing (if not known). An optional tumor biopsy will also be requested.

Participants will continue to be followed by telephone for survival and any new treatments they are receiving.

Eligibility Criteria:
Inclusion Criteria:

* Previous or current treatment with Olaparib in a clinical trial/standard of care that included one of the following as a first step study for epithelial ovarian cancer (including fallopian tube or peritoneal cancer):

  * single agent olaparib given for relapsed disease or
  * single agent olaparib given as maintenance therapy after response to platinum based chemotherapy or
  * olaparib combined with platinum based chemotherapy and then continued as maintenance therapy or
  * olaparib combined with other types of therapy
* Had a durable response to Olaparib defined as patients who have benefited from olaparib for \> 18 months. Patients who discontinued Olaparib due to toxicities but otherwise meet the definition of a durable response will be included or the control group is patients who had a short duration benefit with Olaparib of less than 6 months in any individual clinical trial/standard of care
* Ability to understand and the willingness to sign a written informed consent document.
* Patient's willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures.

Exclusion Criteria:

* Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy
* Pregnant or breastfeeding women
Self-Compassion Enhanced CBT vs. Standard CBT for Social Anxiety (SCE-CBT)

This study evaluates the addition of a self-compassion training in the treatment of social anxiety disorder. Half of the participants will receive a self-compassion enhanced group cognitive-behavioral therapy, while the other half will receive standard group cognitive-behavioral therapy.

There is growing evidence showing that shame is associated with social anxiety. Also, empirical data shows that individuals with social anxiety have higher levels of shame compared with healthy individuals and that shame might play an important role in the maintenance of social anxiety symptoms. Although cognitive-behavioral therapy for social anxiety seems to reduce the level of shame-proneness, the magnitude of this reduction is a small one.

The purpose of this study is to test whether adding a self-compassion component (which seems to be effective in reducing shame feelings) to a cognitive-behavioral protocol would increase the efficacy of the treatment in reducing both shame-proneness and social anxiety symptoms compared with a standard cognitive-behavioral intervention.

Eligibility Criteria:
Inclusion Criteria:

* subjects diagnosed with Social Anxiety Disorders using the DSM-5 criteria
* subjects that have SAD as the primary diagnosis according to DSM-5 criteria
* exceed the cutoff scores on SPIN, SIAS, and LSAS-SR

Exclusion Criteria:

* subjects that score over 29 points at BDI-II
* display suicidal ideation (i.e., exceed a score of 2 on the suicide item of BDI-II)
* undergo other forms of treatment for SAD
* have a diagnosis of psychosis, bipolar disorder or personality disorders according to DSM-5 criteria
Protocol for Facilitating the Acquisition of Research Bone Marrow and Blood Samples

This clinical research protocol is intended to allow for bone marrow aspirate/biopsy and blood specimens to be collected for research purposes, specifically allowing subjects the option of sedation during the bone marrow procedure. Samples will be banked for future research related to cancer and other diseases. Researchers hope this protocol will improve the collection of research correlative and translational biopsy specimens for clinical research.


Eligibility Criteria:
Inclusion Criteria:

* Planned procedure including a bone marrow aspirate and/or bone marrow biopsy
* The procedure is planned for the purpose of obtaining a research specimen (as part of another research study or as part of this stand-alone sample collection protocol.). Procedures with a dual purpose (i.e. to obtain both clinically-indicated specimens and research specimens) are permitted, but procedures to obtain clinical specimens only are not permitted.
* All subjects must provide written informed consent for the biopsy procedure, the collection of bone marrow and blood specimens for research purposes and (if planned) the administration of sedation.

Exclusion Criteria:

* Moderate sedation may not be administrated to subjects with a clinical contraindication to its provision, or if the investigator believes that administration of moderate sedation would constitute under risk to the subject.
Early Phase Clinical Trial About Therapeutic Biological Product Mix for Treating CEA Positive Rectal Cancer

Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients.

1. Treat CEA positive rectal cancer via Trained Immunity.
2. Activate human CEA Protein Antigen Presentation Reaction.
3. The human antigen presenting cells (APCs) can treat the CEA protein antigen into small peptide fragments, and then kill CEA positive rectal cancer cells in vivo.

* Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix activity that suggests the potential for clinical benefit of CEA positive rectal cancer patients
* 20 CEA Positive Rectal Cancer Patients
* Positive testing CEA by blood-drawing
* TB negative participant is negative IGRA blood test with TB antigens
* Clinical Rectal Cancer Diagnosis Stage 0 - IIA
* Clinical Rectal Cancer Diagnosis without symptoms
* Clinical Rectal Cancer Diagnosis without metastasis
* CEA protein antigen 0.05 mg plus BCG Organism 50 MG Mix
* By the percutaneous route with the multiple puncture device
* Positive IGRA blood test with CEA protein antigen after percutaneous use 21 days
* Our trial duration will be 12-week duration

Eligibility Criteria:
Conducting an early phase clinical trial to assess CEA Antigen Presentation Therapeutic Biological Product Mix that suggests the potential for clinical benefit of CEA positive rectal cancer patients.

20 CEA Positive Rectal Cancer Patients

Inclusion Criteria:

* Clinical Rectal Cancer Diagnosis Stage 0 - IIA
* Clinical Rectal Cancer Diagnosis without symptoms
* Clinical Rectal Cancer Diagnosis without metastasis
* Positive testing CEA by blood-drawing
* TB negative participant is negative IGRA blood test with TB antigens.

Exclusion Criteria:

* Pregnant
* Thrombosis
* Allergy
* TB positive participant is positive IGRA blood test with TB antigens.
* Symptoms of rectal cancer
* Metastasis of rectal cancer
* Evidence of critical illness
Processed Residual Pump Blood in Cardiac Surgery: The PRBC Trial

The study is an randomized controlled trial (RCT) of 198 coronary artery bypass graft (CABG) patients, exploring whether ultrafiltration of residual blood in the cardiopulmonary bypass circuit reduces transfusion and bleeding.

Blood products are a limited resource and cardiac surgery is a high consumer. Processing residual cardiopulmonary bypass (CPB) volume via ultrafiltration may improve hemostasis and reduce transfusion through clearing activated complement, activated coagulation components, and proinflammatory cytokines. Unlike cell saver technology, ultrafiltration has the advantage of maintaining plasma proteins, platelets, and coagulation factors. We sought to establish if the processing of residual CPB volume with ultrafiltration reduces homologous blood transfusion and bleeding.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years of age
* were to undergo isolated on-pump CABG
* were able to give informed consent

Exclusion Criteria:

* performed autologous blood donation
* underwent off-pump CABG
* emergency procedure
* resternotomy
* known bleeding disorder not drug related
* history of heparin-induced thrombocytopenia
* Jehovah's Witness
* intra-operative catastrophe prior to randomization
Phase 4 Study of Dolutegravir (DTG) in Russian Federation

DTG 50 milligram (mg) tablet was approved for marketing in Russian Federation; however, DTG is not currently available for subjects at Acquired Immune Deficiency Syndrome (AIDS) Centers as it is not available for order and supply via Federal program. This study is an open-label study which will include subjects, who complete taking DTG in studies ING112276, ING113086, ING114915, ING111762, and those subjects who end participation in study 200304 in which they received either DTG or lopinavir/ritonavir (LPV/RTV). DTG will be supplied at a dose of 50 mg once daily to eligible subjects until the subject stops taking DTG or transitions to commercial supply of DTG when available at AIDS Centers via the Federal program. The objective of this study is to bridge the gap between the closure of ING112276, ING113086, ING114915, ING111762 or end of subject's participation in 200304 and the actual availability of commercial DTG at AIDS Centers via Federal program for human immunodeficiency (HIV)-1-infected adult subjects in Russian Federation. The study will also investigate long-term safety of DTG for subjects continuing DTG in Russian Federation.


Eligibility Criteria:
Inclusion Criteria:

* The subject must complete an End of Study (EOS) visit for the originating protocol ING112276, ING113086, ING114915, ING111762, or be withdrawn from 200304 and attend withdrawal visit prior to transitioning to this study.
* Documented evidence of plasma HIV-1 RNA measurement \<50 c/mL at the EOS visit in ING112276, ING113086, ING114915, ING111762, 200304 (for subjects receiving DTG ) and \<400 c/mL for subjects prior receiving LPV/RTV in 200304.
* Based on medical assessment by the subject's Principal Investigator, the subject continues to derive clinical benefit from treatment with DTG as part of combination antiretroviral therapy (cART) and demonstrates stable virologic success. For subjects, currently receiving LPV/RTV and finishing their participation in 200304, possibility to derive clinical benefit from treatment with DTG is assessed by Principal Investigator following recommendation of Independent Data Monitoring Committee (IDMC).
* Subjects must be capable of giving signed informed consent to participate in this study.

Exclusion Criteria:

* Subjects not currently enrolled in clinical study ING112276, ING113086, ING114915, ING111762, 200304 are not eligible for this study.
* Subjects for whom confirmed virologic withdrawal criteria were met in ING112276, ING113086, ING114915, ING111762, 200304 are not eligible.
* In addition to the above mentioned criteria, investigator/physician must confirm that the subject has no prohibited clinical condition (other medicines or other health conditions, such as hepatic or renal contra-indications). Further, all women of child bearing potential must be cautioned that DTG is not approved for use in pregnancy, and be advised that birth control measures should be in place while taking DTG. Subjects who were permanently discontinued from DTG in the previous study due to intolerance must not be included in this study.
Institut Paoli Calmettes Chronic Lymphatic Leukemia Database

Database of Institut Paoli-Calmettes patients diagnosed with chronic lymphatic leukemia


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic lymphatic leukemia

Exclusion Criteria:

* Score of Matutes \<4
Heat Acclimation, Hand Cooling Efficacy, and Adaptation Maintenance.

This study had three aims:

1. To determine the impact of consecutive days of exercise on thermoregulation and cardiovascular strain.
2. To determine the efficacy of a hand cooling device to cool individuals throughout a heat acclimation period.
3. To assess the maintenance of thermoregulatory and cardiovascular adaptations derived from heat acclimation during a 25-day intermittent exercise-heat exposure protocol.

Participants completed 14 days of exercise heat acclimation in either a hot or cool environment, followed by a heat or cool exercise exposure every 5th day for 25 days. Cardiovascular, thermoregulatory, and perceptual strain were measured throughout exercise each day. Hydration assessment and stress response via blood biomarkers were measured before and after exercise. Aerobic capacity was measured before and after heat acclimation as well as after the intermittent exercise-heat exposure. Hand cooling was implemented periodically during exercise-heat stress visits to determine cooling efficacy before and after heat acclimation.

Eligibility Criteria:
Inclusion Criteria:

* no chronic health problems
* no previous history of exertional heat stroke within the past 3 years
* no history of cardiovascular, metabolic or respiratory disease
* no current musculoskeletal injury that limits physical activity

Exclusion Criteria:

* women
* exercise less than once per week
* VO2max \< 45 ml/kg/min