cyrilzakka/clinical-trials huggingface dataset:
Acupuncture as a Complementary Therapy for in Vitro Fertilization Patients: a Randomized Controlled Trial

This is an open-label randomized controlled trial of the use of acupuncture in infertile patients receiving In Vitro Fertilization (IVF). Patients will be randomized into two groups: treatment group will receive acupuncture as a complementary approach to IVF and control group will receive the IVF treatment. Groups will be compared with the World Health Organization quality of life (WHOQOL-Bref), short-form 36 (SF-36), State Trait Anxiety Inventory (STAI) and Scope-Stress questionnaires.

This is an open-label randomized controlled trial of the use of acupuncture in infertile patients receiving In Vitro Fertilization (IVF). Patients will be randomized into two groups: treatment group will receive acupuncture as a complementary approach to IVF and control group will receive the IVF treatment. Groups will be compared with the World Health Organization quality of life (WHOQOL-Bref), short-form 36 (SF-36), State Trait Anxiety Inventory (STAI) and Scope-Stress questionnaires. In addition, data from medical records of infertile patients submitted to in vitro fertilization for treatment of infertility will be compared in the two different treatment groups (with and without acupuncture), such as the required dose of drugs for the treatment, number of ovarian follicles, number of oocytes captured, quality of oocytes, number of embryos, quality of embryos, pregnancy and abortion rates.

Eligibility Criteria:
Inclusion Criteria:

* female patient
* age over 18 years
* diagnosis of infertility with indication of IVF
* agreement accept to participate in the study
* signature of the consent form

Exclusion Criteria:

* history of previous contact with the acupuncture technique
* severe neurological or psychiatric disorders that make it impossible to participate in the study
AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers

This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).


Eligibility Criteria:
Inclusion Criteria:

1. Have participated in the informed consent process and signed a study-specific informed consent document.
2. Be able and willing to comply with study procedures, including study visits, study dressing regimens, and compliance with study required offloading device.
3. Be ≥ 21 years of age.
4. Have Type I or Type II diabetes mellitus with Investigator-confirmed glycosylated hemoglobin (HbA1c) of ≤ 12%.
5. Have at least one diabetic foot ulcer Ulcer size (i.e., area) is \> 1 cm2 and \< 12 cm2.
6. Have adequate vascular perfusion of the affected limb

Exclusion Criteria:

1. The subject was previously randomized and treated under this clinical study protocol.
2. The study ulcer has features that necessitates surgical operating-room debridement and/or penetrates to capsule/tendon/bone.
3. The subject is unable to safely ambulate with the use of a study required offloading boot.
4. The subject has suspected or confirmed gangrene or wound infection of the study ulcer.
5. The subject has suspected or confirmed osteomyelitis.
6. In the opinion of the Investigator, the subject has received or is scheduled to receive during study participation, a medication or treatment which is known to interfere with or affect the rate and quality of wound healing
7. The subject has a history of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy prior to signing the Informed Consent Form for trial participation.
8. The subject is currently pregnant or is actively trying to conceive.
9. In the opinion of the Investigator, the subject is unable to comply with the treatment regimen
10. In the opinion of the Investigator, the subject has a history of, or is currently diagnosed with, any illness or condition, other than diabetes, that could interfere with wound healing.
11. In the opinion of the Investigator, the subject has a condition that could inhibit wound healing.
12. The subject has ulcers secondary to a disease other than diabetes.
Vitamin D for Established Type 2 Diabetes (DDM2)

This research study in adults with established type 2 diabetes will test whether daily vitamin D supplementation affects how the body processes glucose (sugar).


Eligibility Criteria:
Inclusion Criteria:

* Established type 2 diabetes, defined by one of the following two criteria:
* Age ≥ 25 years and ≤ 75 years
* BMI: 23 to 40 kg/m2 inclusive
* Provision of signed and dated written informed consent prior to any study procedures.

Major Exclusion Criteria

* "Severe" diabetes defined by one of the following criteria:
* - (a) Symptoms of hyperglycemia;
* - (b) Screening HbA1c ≥ 7.5 \[may indicate potential for rapid progression during the trial necessitating need to amplify diabetes-specific pharmacotherapy\]
* History of nephrolithiasis or hypercalcemia
Enhanced Human Sensorimotor Integration Via Self-modulation of the Somatosensory Activity

The purpose of this study is to examine the functional and structural modification effects on the brain of a non-invasive experimental device applied to the head and forearms of healthy subjects during motor recall training. The experimental device used in this study is the Brain-Machine Interface (hereinafter referred to as BMI), which is under development in the principal investigator's laboratory. The BMI consists of an arithmetic unit that processes the results in real time using a personal computer, a depth ray that displays the results, a transcutaneous electrical stimulator that is driven based on the results of the arithmetic, and an exoskeletal motor assist device that is driven based on the results of the arithmetic.

This study does not fall under the category of 'medical research involving human subjects' or 'clinical research subject to legal regulations' in Japan, and the appointment of a principal investigator (PI) is not required. For the convenience of registry submission, the name of the principal investigator field has been filled with the name of the study representative (a non-physician).

Eligibility Criteria:
Exclusion Criteria:

* History of neurological disorder
Efficacy and Safety of Two Doses of Formoterol Fumarate MDI (PT005) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), Compared to Foradil® Aerolizer® as an Active Control

The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Key Inclusion Criteria:

* Signed written informed consent
* 40 - 80 years of age
* Fluency in written and spoken English
* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
* Current/former smokers with at least a 10 pack-year history of cigarette smoking
* A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70
* A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
* Competent at using the inhalation device

Key Exclusion Criteria:

* Women who are pregnant or lactating
* Primary diagnosis of asthma
* Alpha-1 antitrypsin deficiency as the cause of COPD
* Active pulmonary diseases
* Prior lung volume reduction surgery
* Abnormal chest X-ray (or CT scan) not due to the presence of COPD
* Hospitalized due to poorly controlled COPD within 12 weeks of Screening
* Poorly controlled COPD, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician within 6 weeks of screening or between screening and visit 2
* Lower respiratory tract infection requiring antibiotics within 6 weeks of screening
* Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG or uncontrolled hypertension)
* Positive Hepatitis B surface antigen or Hepatitis C antibody
* Cancer that has not been in complete remission for at least 5 years
* History of hypersensitivity to any beta2-agonists or any study drug component
* History of severe milk protein allergy
* Known or suspected history of alcohol or drug abuse
* Medically unable to withhold short acting bronchodilators for 8-hours
* Use of prohibited medications prior to screening and during the study as specified in the protocol
* Receiving long-term-oxygen or nocturnal oxygen therapy for \>12 hours a day
* Participation in acute phase of pulmonary rehabilitation within 4 weeks of screening or will enter acute phase of pulmonary rehabilitation program during study
* Unable to comply with study procedures
* Prior participation in a Pearl PT005 study
* Requires use of a spacer due to poor hand-to-breath coordination
Video Training on Pre-Pregnancy Fear of Birth in Male Partners

This study aimed to evaluate the effect of an online video training on fears surrounding childbirth given to male partners before the pregnancy of their spouses. The study conducted with 43 male (22 intervention; 21 control) participants. Participants were divided into intervention and control groups. The intervention group was given video training on pregnancy and the birth process. \&#34;Descriptive Information Form\&#34; and the "Male-Childbirth Fear Prior to Pregnancy Scale" was used for data collection. Before the intervention, it was found that the fear level of childbirth was low. The video training given to male partners before the pregnancy of their spouses diminished the fear of birth but did not create a significant difference. These findings support long-term training that includes video tutorials for parents before birth. Interactive, participatory birth preparation training is likely to enhance the training's appeal for male partners.


Eligibility Criteria:
Inclusion Criteria:

(i) must be married (ii) must be male gender (iii) must participate voluntarily

Exclusion Criteria:

(i) to have a spouse who had been previously pregnant or having a living child.
Evaluation of Three Strategies of Second-line Antiretroviral Treatment in Africa (Dakar - Bobo-Dioulasso - Yaoundé)

Since the first line antiretroviral (ARV) treatment is now largely accessible in the Sub-Saharian Africa countries, documentation of virological failure, drug resistance patterns and second line treatment evaluation are still to be consolidated in settings where viral load monitoring is not available and non-B HIV subtype is predominant.

This trial aims at evaluating the efficacy and tolerance of 3 different second line treatment strategies: two recommended by WHO combine two non-nucleoside reverse transcriptase inhibitor associated with a ritonavir boosted protease inhibitor (emtricitabine-tenofovir-lopinavir/ritonavir and abacavir-didanosine-lopinavir/ritonavir); the third strategy combines emtricitabine-tenofovir-darunavir/ritonavir and is not yet evaluated in Sub-Saharian Africa. Darunavir has a potentially superior antiviral efficacy, a better tolerance and its single daily administration may facilitate treatment adherence.


Eligibility Criteria:
Inclusion Criteria:

* Patient over the age of 18 years at pre-inclusion and monitored under outpatient conditions
* Documented HIV-1 infection regardless of clinical stage and CD4 lymphocyte count
* Patient with treatment failure after first-line antiretroviral treatment with a combination including a non-nucleoside reverse transcriptase inhibitor and two nucleoside reverse transcriptase inhibitors, failure being defined as 2 measurements (at 1 month interval) of plasma HIV RNA levels \> 1000 copies/ml after at least 6 months of uninterrupted treatment
* Adherence (\> 80%) to first- line antiretroviral treatment (questionnaire) at pre inclusion
* Patient agrees not to take any concomitant medication during the trial without informing the investigator
* Informed consent signed no later than D-15
* For women in childbearing age: negative pregnancy test at inclusion, with no plan of pregnancy in the coming 12 months and agreeing to use mechanical contraception (with or without hormonal contraception) during the study

Exclusion Criteria:

* Infection with HIV-2 or HIV-1 groups O or N or HIV1+2
* Deficiency of the patient, making it difficult, if not impossible, for him/her to take part in the trial or understand the information provided to him/her
* Participation in any other clinical trial
* Presence of an uncontrolled, ongoing opportunistic infection or of any severe or progressive disease
* First-line treatment with a protease inhibitor, abacavir, tenofovir or ddI
* Ongoing treatment with rifampicin
* Severe hepatic insufficiency (TP \< 50%)
* ALAT \> 3 x ULN
* Creatinine clearance calculated by Cockcroft formula \< 50 ml/min
* Hb ≤ 8 g/dl
* Platelets \< 50,000 cells/mm3
* Neutrophiles \< 500 cells/ mm3
* Use of drugs prohibited in the context of this trial (drugs contraindicated by the SCP of the trial drugs) - in the event of tuberculosis or malaria during the trial, a list of authorized medicines and, if necessary, a dose adjustment of the antiretroviral medication will be provided
* Pregnancy or lactation
ED to EPI: Using SMS to Improve the Transition from the Emergency Department to Early Psychosis Intervention

Psychosis is a disabling condition that typically has its onset in adolescence and early adulthood. Many young people with psychosis have difficulty navigating services or are reluctant to engage in treatment until their illness becomes an emergency. Consequently, nearly half of all new psychotic disorders are diagnosed in the emergency department (ED). Despite the rationale and evidence for early psychosis intervention (EPI), around half of youth do not access these services. The investigators will use short message service (SMS)/text messaging, a low-cost, low-complexity, youth-friendly approach, to improve transitions in care from the ED and related acute services to EPI services, investigating the intervention's effect on attendance at the first consultation appointment, longer term service engagement, and system-level outcomes. The investigators will also evaluate cost-effectiveness and user perspectives of the intervention.

At the Centre for Addiction and Mental Health (CAMH), the investigators will recruit a consecutive series of 186 participants aged 16 to 29 referred by the CAMH ED and related acute services to CAMH's EPI program for a pragmatic randomized controlled trial of a 2-way SMS intervention involving reminders, psychoeducation, and check-ins. The primary outcome will be rate of attendance at the first consultation appointment assessed through chart reviews. Secondary outcomes will include indicators of long-term service engagement as well as symptoms and functioning 6 months following study enrollment and health service utilization for up to 2 years using administrative data from the Institute for Clinical Evaluative Sciences (ICES). Administrative data will be used for an economic analysis. Participants who receive the active intervention will be asked to complete a web-based survey evaluating their experience and a subgroup will be asked to participate in in-depth in-person qualitative interviews. Patients and family members with lived experience will be engaged in all aspects of the project, including shaping the intervention and study design.

The investigators hypothesize that the intervention will result in increased rate of attendance at the first EPI consultation appointment, as well as improved longer-term engagement in outpatient EPI services compared to the sham comparator. Demonstrating evidence that this low-cost, low-complexity, youth-friendly intervention improves engagement in outpatient EPI services has the potential to improve long-term outcomes for young people with psychosis.

Eligibility Criteria:
Inclusion Criteria:

* Have been referred by the Centre for Addiction and Mental Health (CAMH) emergency department or related acute services to the CAMH early psychosis intervention (EPI) program for suspected psychosis

Exclusion Criteria:

* Inability to communicate in basic written English
Teriparatide for Improved Knee Prosthesis Fixation

The investigators will study how well knee joint prostheses become fixed to the bone when patients get teriparatide, compared to placebo. Measurements will use high resolution 3D radiography (radiostereometry, RSA).


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee planned for prosthesis surgery

Exclusion Criteria:

* Poor health, drugs affecting bone metabolism.
Investigation of Fatigue, Physical Activity, Sleep Quality and Anxiety Levels

Hundreds of thousands of confirmed cases have been reported worldwide, just 3 months after the first patients were identified in Wuhan, China. Just like other members of the community, MS patients are uncomfortable with the emotional distress and health anxiety caused by the COVID-19 outbreak. Most MS patients receive immunosuppressive or immunomodulatory therapies. Patients taking immunosuppressive agents are theoretically at increased risk of being affected by viral pandemics, and a higher health concern is expected in this group of patients. Moreover, MS patients lose social support. Patients with increased duration of stay can no longer access physical and cognitive rehabilitation therapies. We also know that increased anxiety and sleep disorders can cause MS patients to have an attack.

When literature is examined, it is known that MS patients' physical activity levels decrease, fatigue, sleep quality and anxiety levels increase, so their quality of life and participation in daily life activities decrease. MS patients lose social support during the COVID-19 outbreak. For all these reasons, we think that the fatigue, physical activity level, anxiety level and sleep disturbances affected before the COVID-19 outbreak will be further affected for these reasons.


Eligibility Criteria:
Inclusion Criteria:

* patients with a confirmed diagnosis of clinically definite MS, physician-administered Expanded Disability Status Scale (EDSS) range of 1-5, and following the instructions.

Exclusion Criteria:

* patients with acute attacks (three months prior to the study) and those included on the physiotherapy program during the Covid-19 pandemic.
Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)

The current pilot study assesses the use of magnetic resonance imaging (MRI) to quantify hepatic steatosis. It will provide preliminary data regarding the use of omega-3 fatty acid supplementation (Lovaza) for the treatment of nonalcoholic steatohepatitis (NASH).


Eligibility Criteria:
Inclusion Criteria:

* Males and females at least 18 years of age.
* Evidence of nonalcoholic steatohepatitis (NASH) on a liver biopsy performed within six months of entry to this study.
* Laboratory parameters indicative of decompensated liver disease including:

  * bilirubin less than 2 milligrams/decilitre (mg/dl).
  * stable albumin within normal limits.
  * prothrombin time less than 3 seconds prolonged.
* Serum creatinine less than 1.5 times the upper limit of normal.
* Diabetic patients must be stable on oral medication for diabetes or have had less than a 10 percent change in their insulin dose over the past two months.
* Thyroid stimulating hormone (TSH) or Free Thyroxine Index (FTI) within the normal range.
* Hepatitis C antibody negative.
* Hepatitis B Surface Antigen (HBsAg) seronegative.
* Antinuclear antibody (ANA) less than 1:320.
* Patient provides written informed consent.

Exclusion Criteria:

* Alcohol use exceeding 10 to 29 grams per day during the past six months.
* Evidence of a cause of liver disease other than nonalcoholic steatohepatitis (NASH) on liver biopsy including: viral hepatitis, alcoholic liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha-1 antitrypsin deficiency, or recent hepatoxic drug exposure.
* Patients with cirrhosis.
* Use of medications commonly associated with nonalcoholic steatohepatitis (NASH) including: glucocorticoids, estrogens, tamoxifen, methotrexate, nifedipine, diltiazem, chloroquine, isoniazid, or amiodarone within the past six months.
* Use of non-steroidal antiinflammatory drugs, fibrates (fenofibrate or gemfibrozil) or warfarin within one month of entering the study.
* Uncontrolled diabetes, defined as a glycated hemoglobin (A1C) level greater than 8%.
* Patients with insulin-dependent diabetes.
* History of jejunal-ileal bypass or extensive small bowel resection.
* Substance abuse including, but not limited to, alcohol or intravenous and inhaled drugs within the past six months.
* Use of chemotherapy within six months of enrollment.
* Patients taking metformin.
* Thyroid abnormality in which normal thyroid function cannot be maintained by medication.
* Pregnancy, females who are breastfeeding.
* Solid organ transplant recipient.
* History of a medical condition, which could interfere with participation in and completion of the protocol.
* Use of oral supplements of Vitamin E within one month of enrollment.
Transcutaneous Electrical Muscle Stimulation In Chronic Obstructive Pulmonary Disease (COPD)

Transcutaneous electrical muscle stimulation (TCEMS) is well established intervention for rehabilitation of clinically stable patients with chronic obstructive pulmonary disease.

The investigators have conceived this study to test whether TCEMS is feasible and tolerated by patients experiencing severe physical and psychical challenge of acutely exacerbated COPD.


Eligibility Criteria:
Inclusion Criteria:

* chronic obstructive pulmonary disease GOLD stage III or IV
* acute exacerbation of the disease

Exclusion Criteria:

* contraindications for transcutaneous electrical muscle stimulation