cyrilzakka/clinical-trials huggingface dataset:
Effect of Tramadol in Prevention of Postpartum Depression

The incidence of postpartum depression in Europe and the United States is about 10%, while in China the incidence rate of 15.7-39.8%. Postpartum depression is one of the most common diseases of perinatal distress, but the current research of high-quality prevention and treatment of postpartum depression is still very lack. The study suggests that the risk of postpartum depression in cesarean delivery is significantly higher than that in vaginal delivery. Therefore, postpartum depression in cesarean delivery may require more attention and treatment.Tramadol is a non-opioid central analgesic that relieves common to severe pain, and tramadol has an inhibitory effect on norepinephrine and serotonin systems and has the potential to reduce depression and anxiety. Therefore, for the analgesic demand and antidepressant demand for maternal who undergoing cesarean section, tramadol may be an optimized and effective analgesic for the prevention and treatment of postpartum depression.

This study was designed according to a prospective, randomized, controlled clinical trial. Randomized subjects were randomly assigned to different analgesic drug-treated groups according to the random number induced by SPSS software. All three analgesic treatments were routinely used for clinical analgesia; Anesthesia, surgery, postoperative treatment are in accordance with clinical practice. The investigators conducted a postoperative questionnaire survey and psychological diagnosis for all patients. And blood sample was collected from patients before and 48 hours after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* 20 years old ≤ age ≤ 40 years old;
* ASA score I-Ⅱ;
* uncomplicated and singleton full-term pregnancy;
* voluntarily to receive cesarean section and postoperative controlled analgesia;
* consent to participate the study.

Exclusion Criteria:

* with history of mental disorders or psychotropic substances use;
* with history of neurological diseases such as epilepsy
* with history of previously known diagnosed depression;
* with suicidal ideation or history of suicide;
* with history of drug，alcohol or opioid abuse;
* with monoamine oxidase (MAO) inhibitor treatment at present or in the past 14 days;
* participating in other clinical studies
* with severe heart disease, brain disease, liver disease and kidney disease;
* be allergic to tramadol or opioids;
* with any contraindication for combined spinal epidural anesthesia;
* incapable of communication or cooperation.
TH9507 Extension Study in Patients With HIV-Associated Lipodystrophy

Assessing the Efficacy and Long-Term Safety of a 2 mg dose of TH9507, a Growth Hormone-Releasing Factor Analog, in HIV Subjects with Excess Abdominal Fat Accumulation

HIV lipodystrophy affects a significant proportion of patients treated with combination antiretroviral therapy (ART) and is characterized by excess visceral fat accumulation, loss of extremity and subcutaneous fat, in association with dyslipidemia and insulin resistance. Data from the first Phase 3 multicenter, randomized, placebo-controlled trial demonstrated that daily administration of 2mg TH9507, a growth hormone releasing factor (GRF), to HIV- infected patients with excess of abdominal fat accumulation for 26 weeks resulted in decreases in visceral adipose tissue (VAT) and trunk fat, with lesser changes in limb fat and subcutaneous adipose tissue (SAT). The present study is aimed at confirming the observations made during the first Phase 3 study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who have completed the 26 weeks treatment period of the TH9507-CTR-1011 study.
* Signed informed consent before any trial-related activities.

Exclusion Criteria:

* Fasting blood glucose \>8.33 mmoL (150 mg/dL) at the end of the TH9507-CTR-1011 study.
Ketamine for Treatment-resistant Depression: A Multicentric Clinical Trial in Mexican Population

A randomized multicentric parallel arms study involving the use of ketamine for treatment-resistant depression will be held at three national health provider clinics in the Mexican population. The purpose of this study is to determine whether clinical response seen in previous studies is replicable in this population.


Eligibility Criteria:
Inclusion Criteria:

* Age: 18-65 years old
* Mayor Depressive Disorder Diagnosis based on DSM-IV TR.
* Classification of MDD as treatment-resistant.
* No brain structural abnormalities as evidenced by an MRI scan.
* Signed acceptance of Informed Consent.

Exclusion Criteria:

* Other psychiatric diagnosis apart from MDD.
* Substance abuse or dependence (prior or during study).
* Pregnancy.
* Congestive heart disease.
* Personal history of psychosis.
* First-degree relative with history of psychosis.
* Glaucoma.
* Present neurological disease.
* High blood or pulmonary artery pressure.
* Declining the signing of the informed consent.
Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)

This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.


Eligibility Criteria:
Inclusion Criteria:

* For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years
* For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years
* Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant.
* Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria.

Exclusion Criteria:

* Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit.
* Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism.
* Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201).
* Have previously participated or are currently participating in a gene therapy study for PD.
* Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy).
* Have any physical condition that may confound the motor assessment (MDS-UPDRS) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability).
* Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature
* Have abnormal PFT results at screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Postoperative Supplemental Oxygen in Liver Transplantation

The aim of this prospective randomized controlled trial is to evaluate the impact of high concentration supplemental postoperative oxygen therapy on short-term and long-term results of liver transplantation, particularly with respect to infections and biliary complications.

The aim of this prospective randomized controlled trial is to evaluate the impact of high concentration supplemental postoperative oxygen therapy on short-term and long-term results of liver transplantation, particularly with respect to infections and biliary complications. A total of 296 patients immediately after liver transplantation will be randomly assigned to receive either 80% (high concentration) or 28% (controls) fraction of inspired oxygen for 6 hours after surgery with a 1:1 allocation ratio. Patients will be blinded to the type of received intervention. Randomization will be stratified by the Child-Turcotte-Pugh classification. Both groups will be compared to short- and long-term outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* active liver transplant waitlist status

Exclusion Criteria:

* active infection at the time of transplantation
* malignancy
* cardiac arrest during transplantation
* chronic obstructive pulmonary disease
* acute myocardial infarction
Effect of Glutathione on Blood Alcohol and Hangover Symptoms

Glutathione (a tripeptide of 3 amino acids - glutamic acid, cysteine and glycine) plays a great role in homeostasis, especially as a potent anti-oxidant.

As an anti-oxidant, it conjugates with xenobiotics using glutathione-S-transferase (GST) and excretes in urine as mercapturic acid.

In 1986, Casciani et al at the University of Milan, studied the effect of glutathione on blood alcohol, acetaldehyde and hepatic triglyceride levels and found a significant reducing effect.

The blood acetaldehyde, which is the metabolic product of ethyl alcohol may have a correlation with hangover symptoms. This study is designed to find this correlation using blood alcohol, blood acetaldehyde levels and the Hangover Symptoms Scale according to the Slutske et al study.

Type of Study: Double-blinded control

Population: 100 males

Inclusion Criteria:

* Males 20-40 years
* Healthy, without chronic diseases, especially must have normal hepatic function, measured by serum SGPT
* No history of alcoholic allergy
* Drink alcohol regularly, at least once a week
* Agree to be a subject by standard consent form

Exclusion Criteria:

* Subject wants to end the study
* Some impending danger to subjects

Number of subjects : 100

Methodology

1. Subjects are recruited;
2. History taking, physical examination and SGPT are done by M.D.;
3. 100 subjects are distributed randomly to numbers 1-100;
4. Factory provides 2 groups of capsules in randomized packets numbered 1 -100; each package contains 3 sub-packages; each sub-package contains 2 capsules of either placebo or 370 mg glutathione capsules. All the three sub-packages will be all placebo or all glutathione. 50 packages are placebo and 50 packages are glutathione;
5. Subjects are examined as follows:

   * Hour 0: 3 ml of blood taken for blood alcohol and blood acetaldehyde;
   * Hour 0- 1: consume Thai Whisky (40% alcohol) 60 ml with snacks;
   * Hour 1: ml of blood taken for blood alcohol and blood acetaldehyde;
   * Hour 1.30: ml of blood taken for blood alcohol and blood acetaldehyde;
   * Hour 2.30: ml of blood taken for blood alcohol and blood acetaldehyde;
   * Hour 3.30: ml of blood taken for blood alcohol and blood acetaldehyde;
   * Hour 12: ml of blood taken for blood alcohol and blood acetaldehyde, and Alcohol Hangover Symptom evaluation of each subject is done individually.

Using Wendy S. Slutske et al Scale 0-4:

0= no symptom

1. minimal
2. some
3. much
4. most

Symptoms are

1. extreme thirst or dehydration
2. more tired than usual
3. headache
4. nausea
5. vomiting
6. very weak
7. difficulty concentrating
8. more sensitive to light and sound than usual
9. more sweating than usual
10. have a lot of trouble sleeping
11. anxious
12. depressed
13. trembling or shaking

Blood alcohol, blood acetaldehyde and hangover symptoms are statistically evaluated for significance.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Males 20-40 years old
* No allergies to alcohol

Exclusion Criteria:

* Chronic disease
* Increase in hepatic enzyme SGPT
* Impending danger
Move Study in Healthy Aging People

Bone and muscle losses occur during ageing leading to increased risk of osteoporosis (there are more than 200 million people affected by osteoporosis worldwide), sarcopenia, loss of functionality and mobility. From around 45-50 years onwards, there is a progressive loss of muscle mass and strength (sarcopenia). This is partially due to an impairment of muscle protein synthesis in response to dietary proteins. Insufficient dietary protein may contribute to age-related loss of lean body mass (LBM) and strength which ultimately affects body movement.

Key ingredients in selected investigational product are:Milk proteins, Calcium, Vitamin D, Vitamin C, Glucosamine Sulfate, Zinc. They have effects to improve physical mobility and functionality. The investigators expect improved effects of a nutritional intervention combined with a physical activity program on mobility in healthy aging subjects with joint discomfort.


Eligibility Criteria:
Inclusion Criteria:

* Target 45-65 y old
* Suffering from (knee) pain. VAS on pain assessment \<= 4 on a range 0 to 10
* 20\<BMI\<28
* Time since menopause above 2y
* iPAQ (International Physical Activity Questionnaire) score \<600

Exclusion Criteria:

* OA diagnosed
* Medicine treatment
* Chronic pain killers treatment for more than 7 consecutive days with a washout period of 2 weeks between 2 periods of treatment
* Under corticoid, hormone (adrenal, thyroid) treatment
* Traditional herbal medicine: in particular with claims on strengthening tendons and bones. This point will be included in FFQ (see annex) and evaluate.

Subjects with chronic tablets supplementation ( calcium or drinking milk over 5 day wk-1 will be excluded, vitamin D, GS, or any with effect on bone and joints ) (set up a FFQ to specially investigate intakes of calcium tablets, milk and animal foods)

* Pregnancy
* Subject with knee/joint surgery/replacement and CLA (Cross Ligament) injury
* History of relevant digestive disease, organic disease of heart, liver or kidney, severe function disorder of liver or kidney, metabolic/endocrine , neurological disease (e.g., Parkinson disease, stroke) with residual impairment, vertigo
* Anaemia
* Unable to carry out functional tests and questionnaires correctly (KOOS, physical activity)
* Lower or upper extremity surgery or fracture in the last 3 months
* Currently participating or having participated in another clinical trial in the three previous months
Determination of Abnormal Fetal Growth or Amniotic Fluid With Third Trimester Ultrasounds in Uncomplicated Pregnancies: A Randomized Trial

The purpose of this study is to see whether women at a gestational age of 30 weeks or more without comorbidities, does performance of serial 3rd trimester growth ultrasounds increase the frequency of identifying abnormalities in fetal growth or amniotic fluid, when compared with women who only receive indicated ultrasounds?


Eligibility Criteria:
Inclusion Criteria:

* Maternal age of 18 at the time of consent
* Singleton gestation

Exclusion Criteria:

* First sonographic examination after 20 weeks
* Women with any of the following co-morbidities: Autoimmune disorders (antiphospholipid antibody, lupus, rheumatoid arthritis, scleroderma), Cerclage in the index pregnancy, Diabetes mellitus-gestational or pre-gestational, Hematologic disorders (coagulation defects, sickle cell disease, thrombocytopenia, thrombophilia), Hypertension (chronic or pregnancy induced) before enrollment, HIV (human immunodeficiency virus), Institutionalized individuals (prisoners), Prior obstetric history of: \[1) intrauterine growth restriction, 2) preterm birth before 34 weeks, 3) severe preeclampsia\], eclampsia, HELLP syndrome, and 4) stillbirth after 24 weeks or neonatal death, Preterm labor or ruptured membranes before enrollment, Psychiatric disorder (bipolar, depression) on medication, Placenta previa / 3rd trimester bleeding, Renal insufficiency (serum creatinine \> 1.5 mg/dL), Restrictive lung disease, Fetal red blood cell isoimmunization, Seizure disorder on medication, Thyroid disease on medication, Body Mass Index (BMI) above 40 kg/m2
* Major fetal Anomaly including: anencephaly, spina bifida, bilateral renal agenesis, cystic hygroma with hydrops, diaphragmatic hernia, or congenital heart defects
* Unable to understand consent in English or Spanish
Volumetric Study of the Buttocks After Flap Augmentation in Buttocks Lifting

The development of bariatric surgery, its effectiveness and the reduction of complications are at the origin of massive weight loss, the corollary of which has been a clear increase in the demands of treatment of sequelae of weight loss.


Eligibility Criteria:
Inclusion criteria:

* 12 months minimum delay with bariatric surgery
* female, BMI\<30kg/m2
* Age greater than or equal to 18 years
* Stable weight for more than 6 months
* lack of volume in gluteal region
* agree with clinical trial

Exclusion criteria:

* Patient under tutorship or curatorship
* Pregnancy or breastfeeding
* hemoglobinemia\< 12g/dL
* Albuminemia\<3,5g/dL
* active smoking more than 1 month before surgery
Robotic Surgical Management of Endometriosis: Excision Versus Ablation

Patients who are planning to undergo laparoscopic surgery for endometriosis will be assigned to either ablation or excision of endometriosis. The investigators think that patients who have excision of endometriosis will have greater relief of pain.

Patients with known endometriosis based on prior surgical pathology or suspected endometriosis based on symptomatology who plan on undergoing diagnostic laparoscopy will be offered enrollment in the study. They will complete preoperative pain assessments with the tools outlined above. At the time of diagnostic laparoscopy, patients found to have endometriosis will be staged according to the American Society of Reproductive Medicine guidelines. Patients with Stage 4 or deeply infiltrating endometriosis will be excluded from the study. At that point, the patients will be randomized in the operating room to either laparoscopic excision of endometriosis or laparoscopic ablation with the argon beam coagulator. Patients will be stratified according to the presence or absence of the Levonorgestrel-Intrauterine Device.

Pain assessments will be performed immediately postoperatively in the recovery area. Pain assessments will again be performed at 4 weeks, 6 months and 12 months. We will use the VAS pain scale and validated questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Endometriosis
* Chronic Pelvic Pain
* Stage 1-3 Endometriosis
* Reproductive aged women

Exclusion Criteria:

* Stage 4 Endometriosis
* Deeply Infiltrating Endometriosis
* Patients who decline surgical management of endometriosis
Zip-Stitch™ for Vaginal Cuff Closure in Total Laparoscopic Hysterectomy

ZSX Medical completed enrollment in its First in Human Ease of Use study in May of 2017, in Monterrey Mexico. The purpose of this study is to demonstrate the ease of use of Zip-Stitch™, to generate first in human data, and to refine surgical technique of the device.

Ten subjects were enrolled and received total laparoscopic hysterectomies, including vaginal cuff closure with the Zip-Stitch™ system during their otherwise standard care. Procedures took place over the course of one week. Subjects had in person follow-up appointments at 1 and 6 weeks. Subjects are continuing follow-up through a one-year extension period which will end in May 2018.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated Informed Consent Form
* Stated willingness to comply with all study procedures, including participation in follow-up visits and telephonic follow-up
* Female, age 18 years or older
* Indicated for Total Laparoscopic Hysterectomy

Exclusion Criteria:

* HIV
* Hepatitis C
* Diabetics
* Use of systemic corticosteroids
* History of pelvic irradiation
* Active infection
* History of bleeding problems/hemophilia
* Cancer
* Cases in which vaginal cuff closure is intended to be performed robotically
* Pregnant
Sun Protection Factor Assay (SPF Assay 19009)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Social Cognition and Interaction Training for Autism

Purpose: To collect outcome measures such as eye tracking and questionnaire data prior to and following a group based clinical therapy program to determine the effectiveness of the therapy approach. The therapy program is aimed at improving social cognitions and skills of individuals who find social situations difficult, stressful and/or uncomfortable and with a desire to enhance skills required for social interactions.

Participants: Cohorts of individuals aged 10-69 years old with symptoms of a neurodevelopment disorder, who have general difficulty with social interactions.

Procedures: Participants enrolled in a clinical therapy program for improvement of social cognitions and skills will complete eye tracking tasks, several questionnaires and rating scales, and a diagnostic interview prior to and following the 8 week therapy program. The post treatment assessments will be conducted within a week of the therapy completion and then again approximately 2 months after the last therapy session. The entire study duration is expected to be approximately 17 weeks. These outcome measures will measure the effectiveness of the treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 13-69.
2. Symptoms of a neurodevelopmental disorder.
3. English as primary language and ability to speak in fluent, full length sentences: Treatment will be conducted in a group setting in English.

Exclusion Criteria:

1. Inability to speak English fluently.
Child STEPS for Youth Mental Health in Maine Sustainability

The overarching goal of this project is to study the sustainability of MATCH-ADTC within community mental health clinics, to learn what is needed for evidence-based practices (EBPs) to take root and thrive within a public system.

In this project, the investigators are randomizing children to Wave 1 (previously MATCH trained) or Wave 2 (newly MATCH trained) and using a clinical monitoring system (TRAC) to measure youth outcomes over time. Participating therapists receive weekly MATCH consultation provided by the Judge Baker Children's Center/Harvard University research team or by Maine clinic supervisors who are MATCH Associate Consultants. The investigators are also developing and testing new low-cost measures of MATCH treatment and consultation fidelity to explore the feasibility of more sustainable measures of MATCH adherence. Study data will be used to answer questions about the sustainability of MATCH in the public sector.

Eligibility Criteria:
Inclusion Criteria:

* 6 - 15 year old child and their caregivers
* seeking services at community mental health clinics
* primary problem or disorder related to anxiety, traumatic stress, depression, or conduct problems, or any combination of the four problems

Exclusion Criteria:

* child is younger than 6 years or older than 15 years on the day of the phone screen.
* child has attempted suicide within the past year.
* Schizophrenic spectrum disorder (including MDD with psychotic features)
* Autism or another Pervasive Developmental Disorder (E.g., PDD NOS, Asperger's Disorder, Child Disintegration Disorder, Rett's Disorder)
* Anorexia Nervosa
* Bulimia Nervosa
* Mental Retardation
* no relevant T-scores validate target disorders
* ADHD identified as primary reason for seeking treatment at phone screen
* child's medication has not been regulated for one month or longer