cyrilzakka/clinical-trials huggingface dataset:
Assessing the Effects of Increased Mitochondrial Function Exercise Training on Muscle Performance

As people grow older skeletal muscle gradually becomes smaller and weaker, causing reduced mobility and quality of life. To understand and reverse this negative process investigators need to find new ways of improving the ability of muscle to perform physical activity. There is some evidence that supplements may improve how the mitochondria work, and investigators want to explore this idea in more detail. This is possible by measuring how the muscles work and respond to exercise before and after taking the supplement alongside an aerobic (i.e. cycling) and resistance (i.e. weight lifting) exercise programme. This will give us the basic information investigators would need to see if this is a useful idea.


Eligibility Criteria:
Inclusion Criteria:

* Male
* Age between 65-75 years
* Body mass index between 19-29
* No active cardiovascular or metabolic disease
* No active respiratory disease
* No current musculoskeletal injuries
* A sedentary lifestyle (i.e. does not engage in strenuous, planned physical activity)
* The ability to give informed consent

Exclusion Criteria:

* Currently taking a statin drug or NSAIDs
* Have a current peptic ulcer
* Have any renal impairment
* Have a known hypersensitivity to Acipimox
* Suffer from vertigo
* Smoker
A Non-Drug Study on the Relationship Between Exploratory Biomarkers and Functional Dimensions in Individuals With Autistic Disorder or Asperger's Syndrome

This multi-center, non-drug study will explore the relationship between exploratory biomarkers and functional dimensions in male adult individuals with Autistic Disorder or Asperger's Syndrome and healthy volunteer controls. Subjects will undergo a number of assessments on study visit Day 1.


Eligibility Criteria:
Inclusion Criteria:

Individuals with Autistic Disorder or Asperger's Syndrome:

* Male adults, 18 to 45 years of age inclusive
* Diagnosis of Autistic Disorder or Asperger's Syndrome as defined by DSM-IV
* IQ \>70
* Body mass index (BMI) 18 to 35 kg/m2
* Availability of a reliable caregiver, able and willing to provide information regarding the individual's behavior and symptoms

Healthy controls:

* Healthy male adults, 18 to 45 years of age inclusive
* IQ \>70
* Body mass index (BMI) 18 to 30 kg/m2

Exclusion Criteria:

General exclusion criteria:

* Positive test for drugs of abuse or alcohol
* Confirmed systolic blood pressure \>140 or \<90 mmHg, and diastolic blood pressure \>90 or \<50 mmHg
* Resting pulse rate \>100 or \<40 beats per minute
* Alcohol and/or substance abuse/dependence during the last 12 months
* Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study

Additionally for individuals with Autistic Disorder or Asperger's Syndrome:

* History of epilepsy/seizure disorder (except simple febrile seizures)

  * Significant disruptive, aggressive or self-injurious, or sexually inappropriate behavior during the last 3 months that in the opinion of the investigator might interfere with the conduct of the study

Additionally for healthy controls:

* Clinically significant abnormalities in laboratory test results
* History of or current psychiatric, neurological disorder or pervasive developmental disorder
Viral Triggers in Pediatric Lung Transplantation

The purpose of this study is to determine whether respiratory viral infections increase the risk of bronchiolitis obliterans syndrome (BOS), obliterative bronchiolitis (OB), death, or retransplantation in children who have received lung transplants.


Eligibility Criteria:
Inclusion Criteria:

* Parent or legal guardian willing and able to provide informed consent
* Participant of first single or bilateral heart-lung transplant

Exclusion Criteria:

* Recipient of multi-organ transplant (aside from heart-lung)
* Condition or characteristic which in the opinion of the investigator makes the participant unlikely to complete the study
A Trial Evaluating Autologous Endometrial Co-Culture Versus Conventional Medium in the Treatment of Infertility

One of the main factors in the success of in-vitro fertilization is the quality of the environment of the embryo. In contrast to maternal age, the environment in which the embryo develops is a modifiable factor. Many techniques, such as assisted hatching and perfecting culture media have been attempted in order to reproduce as much as possible the natural, physiological environment of the mother for the embryo in in-vitro fertilization. However, the different new culture media used are devoid of growth factors normally secreted by uterine cells that enhance the interaction between the embryo and its environment.

Because the endometrial lining of the uterus secretes many different cytokines necessary for growth of the embryo, a new procedure has been developed to mimic the natural environment of the growing embryo using autologous (patient's own) endometrial cells in co-culture with the embryo. Endocell, a product developed by Genévrier Laboratories, received commercial authorization in France in 2011. It is the only system of autologous embryo-endometrium co-culture available on the actual market. The process consists of developing the embryo on a monolayer of the patient's own endometrial cells in order to favor its growth until the blastocyst stage (day 5) and to improve its implantation.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing In Vitro Fertilization (IVF) or IVF/Intra Cytoplasmic Sperm Injection (ICSI) at OVO clinic
* Having a prescription of a long, short or an antagonist IVF protocols using both urinary and synthetic gonadotropins
* Having a single embryo transfer
* Regular menstrual cycles
* Basal follicle stimulating hormone levels less than 10 IU/l within 6 months prior to entering the study
* anti-mullerian hormone more than 1 ng/ml measured within a year
* Normal sonohysterogram or hysteroscopy done within the last 2 years
* Previously undergone a maximum of 3 IVF cycles
* Documented negative serology tests within 1 year prior recruitment for: Hepatitis B, Syphilis, HIV based on Health Canada recommendations for treatment in an IVF laboratory.

Exclusion Criteria:

* Amenorrhea
* Anovulatory cycles
* Polycystic Ovarian syndrome
* Chronic endometritis
* Severe endometriosis
* Hydrosalpinx
* Uterine synechia or Asherman's syndrome
* Submucosal uterine fibroids or intra-cavitary polyps greater than 1cm
* Uterine anomalies
* Use of anticoagulants
* Secretory Azoospermia
Feasibility Study: Evaluation of Ulthera Versus Thermage for Treating the Face and Neck

Up to 20 subjects will be enrolled and randomly assigned to one of two treatment groups. Group A will receive Ultherapy™ on the right side of the face and neck and Thermage on the left side. Group B will receive Thermage on the right side of the face and neck and Ultherapy™ on the left side. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.

This is a prospective, single-center, double-blinded, split-face, randomized pilot study. A triple Ultherapy® treatment and standard Thermage treatment will be provided to all subjects to the full half face, neck, and submental areas. Changes in face and neck skin laxity and wrinkles, from baseline and between study treatments, will be assessed at study follow-up visits. Patient satisfaction questionnaires will also be obtained.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age 30 to 65 years.
* Subject in good health.
* Skin laxity on the area(s) to be treated.
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated through the follow-up period.
* Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.

Exclusion Criteria:

* Presence of an active systemic or local skin disease that may affect wound healing.
* Severe solar elastosis.
* Excessive subcutaneous fat in the area(s) to be treated.
* Excessive skin laxity on the area(s) to be treated.
* Significant scarring in the area(s) to be treated.
* Open wounds or lesions in the area(s) to be treated.
* Severe or cystic acne on the area(s) to be treated.
* Presence of a metal stent or implant in the area(s) to be treated.
* Inability to understand the protocol or to give informed consent.
* Microdermabrasion, or prescription level glycolic acid treatment to the treatment area(s) within two weeks prior to study participation or during the study.
* Marked asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin in the area(s) to be treated.
* BMI equal to or greater than 25.
Safety and Efficacy of Buprenorphine Transdermal System in Subjects With Moderate to Severe Osteoarthritis of Hip or Knee

The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) (5, 10 and 20) in comparison to placebo transdermal system in subjects with moderate to severe osteoarthritis pain of the hip and knee currently treated with oral opioids. The double-blind treatment intervention duration is 4 weeks during which time supplemental analgesic medication (acetaminophen) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of chronic osteoarthritis of the hip or knee for 1 year or longer.
* an average pain due to osteoarthritis of moderate, moderately-severe, or severe for the 14 days prior to enrollment.

Exclusion Criteria:

* ingest opioid analgesics on a daily basis.
* ingest \>2500 milligrams (mg) acetaminophen on a daily basis.
* require \<20 mg or \>80 mg of morphine (or opioid equivalents) per day for control of their osteoarthritis pain.

Other protocol-specific exclusion/inclusion criteria may apply.
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain

This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery. One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo. Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction. The control group will receive placebo saline infusions at the same time intervals. All subjects will receive as needed (prn) IV narcotic for additional pain relief. Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge. We will also collect total IV narcotic consumption. We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.

see brief summary

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 70 years
* Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio
* Scheduled to undergo major vaginal reconstruction
* Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.

Exclusion Criteria:

* Allergy to acetaminophen
* Liver disease (chronic or active)
* Chronic alcohol use (\>1 drink/day)
* Bleeding diathesis
* Renal disease
* Opiate dependent or daily use
* History of chronic pain
* Mental or cognitive disorder preventing patient to accurately verbalize pain levels
* Undergoing abdominal or laparoscopic procedures at the time of surgery
* Allergy to hydromorphone
* Surgery is not performed under general anesthesia
Peroneus Longus Graft :Effect in Foot and Ankle Function

The purpose of this study is to report the ankle and foot functions via American orthopedic foot and ankle society score (AOFAS), peronei muscle testing ,handheld dynamometer and radiological outcomes after harvesting autogenous peroneus longus tendons for ligaments reconstruction.

Using a Peroneus longus tendon (PLT) as an autograft is a common procedure and has been used previously for deltoid ligament reconstruction in flatfoot deformity correction . Recently, (PLT) is gaining popularity as a graft option in primary anterior cruciate ligament (ACL) reconstruction surgeries with biomechanical studies showing tensile strength and clinical outcomes comparable to quadrupled hamstring grafts.

In addition to using PLT for isolated (ACL), it is also used in posterior cruciate ligament (PCL) reconstruction, medial collateral ligament reconstruction, posterolateral corner reconstruction of the knee, or knee multiple ligament injuries . The partial-thickness of the tendon has been used variably in knee ligament surgery..

Being a powerful muscle in plantar flexion and eversion of the foot, there might be associated ankle functional impairment. To the authors knowledge, there is a gap in science evaluating donor site morbidity. The aim of this study is to report the clinical and functional outcome of the donor site for better explanation of the cons and pros of using PLT as a graft in joint ligamentous injury .

Eligibility Criteria:
Inclusion Criteria:

1. clinical and radiological diaginsis of joint ligament injury and needs to ligament reconstruction .
2. people with asymptomatic ankle and foot pre and post injury

Exclusion Criteria:

1. Associated ankle and/or foot fractures.
2. Associated hip or pelvic fractures
3. Abnormal ankle function pre-injury.
4. Contralateral limb fractures
5. Traumatic brain injury (TBI) that limits their ability to participate in their post-operative care;
6. Presence of neurological condition that result in spasticity or any abnormal lower limb muscles tone.
7. Any condition that would preclude the ability to comply with post-operative guidelines.
A Phase I Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetic Characteristics of LC28-0126.

To assess the safety, tolerability and pharmacokinetic characteristics of LC-28-0126 multiple iv injection in healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 19 and 45 years at screening.
* Subjects with BMI between 18.0(inclusive) and 27.0 kg/m2 (exclusive); and a total body weight between 55 kg (inclusive) and 90 kg (exclusive)

Exclusion Criteria:

* Participation in a clinical research study within the previous 3 months
* Regular alcohol consumption \>21 units per week.
New Biomarkers Associated With the Risk of Premature Delivery.

Despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality.

This study aims to estimate the prognostic value of new biomarkers (proteomic markers) on the occurrence of preterm birth.

Despite the progress made in the organization of care and neonatal care, prematurity remains the main cause of morbidity and perinatal mortality. With 7.2% of premature deliveries in France, threat of premature labor remains the leading cause of maternal transfer and hospitalization. In terms of mortality, morbidity and cost, the fight against prematurity remains a national priority in terms of public health.

The diagnosis of threat of premature labor at high risk of preterm labor is difficult and clinical and laboratory criteria often remain insufficient. Measurement of the cervix by endovaginal ultrasound lacks sensitivity and specificity. Among the biological criteria, only fibronectin, which has a good negative predictive value, is used in current practice. Despite the use of these two prognostic criteria, only 40% of hospitalized patients will give birth prematurely.

Recent advances in proteomics allow us to study complex proteomes and compare them. Preliminary studies already carried out have revealed families of proteins expressed differently in situations of work or premature delivery. We therefore hypothesize that the study of a woman's vaginal proteome with threat of premature labor may reveal new markers of preterm labor. These markers could help the clinician in its therapeutic management and thus reduce hospitalizations, better target patients requiring tocolytic treatment and optimize the use of corticosteroids. In addition, variations in the proteome may help to understand the physiopathological mechanisms of premature delivery, which are necessary for the development of effective therapeutics.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women over 18 years of age
* Term from 22 to 33 and 6 amenorrhea weeks
* Single or twin pregnancy
* Emergency consultant, in participating centers, for a threat of premature labor defined by:

Uterine contractions greater than or equal to 3 in 30 minutes Clinical modification of the cervix Ultrasound collar less than 25 mm

* Free, informed and written consent, dated and signed by the patient and the investigator before any investigation required by the research.
* Patient affiliated to a Social Security scheme.

Exclusion Criteria:

* Premature rupture of membranes
* Placenta previa
* Vaginal haemorrhage at the time of sampling
* Uterine malformation
* Strapping, open bite
* History of strapping and or open bite
* Conization
* Fetal malformation
* Associated vasorenal pathology
* Sexual intercourse less than 24h
* Gynecological examination less than 48h
* Vaginal treatment in progress
* Polyhydramnios
* Transfused-transfused syndrome
* Twin Anemia Polycythemia syndrome
* Fetoscopy during pregnancy
Efficacy and Safety of Traditional Chinese Medicine (TCM) Comprehensive Therapy in Patients With Rheumatoid Arthritis

This is prospective randomized, controlled study to evaluate the efficacy and safety of Qingre Huoxue comprehensive therapy in treating of patients with early Rheumatoid Arthritis (RA). The major outcome index is the change from baseline to week 24 in Disease Activity Score (DAS28), and minor outcome indexes include American College of Rheumatology (ACR)20/50/70, PRO score, Sharp score and OMERACT RAMRIS score. The adverse events at any time were recorded to evaluate the safety.

Three arms were included in this study, and treatment with MTX and HCQ is defined as active comparator. Treatment of TCM，including Qingre Huoxue granule, Qingre Huoxue external preparation, MTX placebo and HCQ placebo, is defined as one experimental arm. Treatment of integrative medicine，including Qingre Huoxue granule, Qingre Huoxue external preparation, MTX and HCQ, is defined as another experimental arm.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with rheumatoid arthritis as determined by the 1987 ACR classification criteria.
* Diagnosed with TCM dampness heat and blood stasis syndrome
* The course of RA is not more than 5 years.
* Swollen joint (SJC)≥2 and tender joint count(TJC)≥3.
* Erythrocyte Sedimentation Rate（ESR）≥20 mm/hr
* Patients who take disease-modifying antirheumatic drugs for at least 3 months on a stable dose, and retain the same treatment during the study.
* Age 18-65 years with informed consent

Exclusion Criteria:

* Patients with skin burst or allergies.
* Patients with cancer or other malignant disease such as cardiovascular, hematopoietic, liver and kidney disease, and psychopath
* Active or chronic infection, including HIV, hepatitis C virus, hepatitis B virus, tuberculosis
* Previous treated with tripterygii, glucocorticoid or biologic disease-modifying antirheumatic drug (DMARD) in 3 months.
* Previous treated with MTX or HCQ
* Patients with retinopathy.
Real World Study of Oxycodone Sustained-release Tablets for Patients With Moderate to Severe Cancer Pain

The goal of this real world study is to observe the efficacy and safety of Oxycodone Hydrochloride Sustained-release Tablets in the treatment of moderate to severe cancer pain participants in real clinical practice.

After entering the study, participants will take Oxycodone Hydrochloride Sustained-release Tablets. The investigators need to observe and record relevant data, and finally analyze and summarize the data to understand the efficacy and safety.

This study is a prospective, single arm, multicenter real world study, the investigators didn't set up a control group. After the participant is enrolled, the participant will enter a 14 day treatment cycle, where the medication will be proportionally converted into Oxycodone Hydrochloride Sustained-release Tablets. The daily medication dose will be adjusted based on the number of pain outbreaks and pain scores (According to the drug increment principle of NCCN), and various information (Daily oxycodone dose, average pain score, minimal pain score, most severe pain score, number of breakout pain, name of rescue drugs, number of rescue, heart rate, blood pressure, respiratory rate, SPO2, combination of drugs, pain control satisfaction, etc) about the participant's medication will be recorded. The participant will not be limited to whether to combine medication. Observe the efficacy and safety of Oxycodone Hydrochloride Sustained-release Tablets.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntarily sign an informed consent form;
2. Age ≥ 18 years old;
3. Patients with moderate to severe (NRS ≥ 4 points) cancer pain;
4. Patients with oral equivalent Oxycodone Hydrochloride Sustained-release Tablets ≥ 80mg/d.

Exclusion Criteria:

1. Patients with severe mental illness who cannot cooperate with follow-up
Tunnel vs. CAF for the Treatment of Multiple Gingival Recessions

Many studies have compared the tunnel technique and coronally advanced flap in the treatment of single and multiple recessions. However, there is a lack of evidence that compared both techniques in combination with a connective tissue graft, for just multiple adjacent recessions. No technique is clearly superior to another in terms of complete root coverage (CRC), mean root coverage (MRC) and the gain of keratinized tissue height (KTH) when multiple recession coverage was evaluated. Moreover, as a connective tissue graft supposed to offer more stability in terms of complete root coverage in long-term basis, the main question should be aimed at the role of the sub-epithelial connective tissue graft, when it is used in combination with one technique or another. Hence, the hypothesis is focused on if the use of a connective tissue graft in combination with a tunnel technique would provide higher clinical outcomes and similar patient-based outcomes than its use in combination with the Coronally Advanced flap technique.

Parallel group, clinical evaluator- and statistician-blinded, randomized clinical trial.

Eligibility Criteria:
Inclusion Criteria:

• Subjects with a minimum of two adjacent teeth and a maximum of four adjacent teeth with gingival recessions (at least one with a depth ≥ 3 mm) and requiring surgical intervention, without medical contraindications to elective surgery.

Exclusion Criteria:

* Presence of untreated periodontitis
* Persistence of uncorrected gingival trauma from tooth brushing
* Interdental attachment loss greater than 1 mm or furcation involvement in the teeth to be treated
* Presence of severe tooth malposition, rotation or clinically significant super-eruption
* Self-reported current smoking
* Presence of medical contraindications to elective surgery