cyrilzakka/clinical-trials huggingface dataset:
Animal-Assisted Therapy in Adolescents With Eating Disorders

This study aims to improve eating disorders symptomatology, mental, psychosocial and physical health, quality of life, strength and body composition of adolescents with eating disorders by the development of a dog-assisted therapy program.

The current research will involve thirty-two patients distributed equally in a control and an experimental group. The intervention group will participate once a week in a dog-assisted therapy of seven weeks. Moreover, all the included patients will participate in an assessment session before and after the intervention to compare the effects of the dog-assisted therapy within and between groups in anxiety, depression, character, behavior, eating disorder evolution, health-related quality of life, treatment satisfaction, strength and body composition.

Based on previous studies on different populations, it is expected that, compared to the control group, the experimental group may experience a potential reduction in anxiety, depression and symptoms, while improving quality of life, strength, body composition and behavior.

Animal-Assisted Therapies (AAT) have proved to increase self-esteem, social capacity and impulse control while reducing anxiety and depression. Thus, AAT could be an innovative and effective therapy to improve the mental, social and physical health of adolescents with eating disorders.

Based on previous studies on different populations, it is expected that, compared to the control group, the experimental group may experience a potential reduction in anxiety, depression and symptoms, while improving quality of life, strength, body composition and behavior.

Thirty-two adolescents, younger than 18 years and diagnosed with eating disorders from the University Hospital Niño Jesus will participate in this study. The informed consent must be signed to be included in the study.

The intervention will consist of 7 weeks conducted once a week (50 minutes each session). It will include three parts: 1) a welcome part aimed to get in touch with the dog, 2) a main part, where participants will be taught basic notions about dog training and then try to train the dogs. In this part, the patients will perform different activities and exercises with the dog. 3) A closing part to say goodbye to the dogs.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents in the Psychiatry and Psychology Service of the Niño Jesús University Hospital
* Patients diagnosed with eating disorders
* Adolescents with the willingness to participate and availability to assist
* Having read and signed the written informed consent.

Exclusion Criteria:

* Patients with dog-allergy or dog phobia
* Adolescents with a history of impulsive animal aggression
The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical

The purpose of this study is to determine effective incision type for the treatment of chronic anal fissures.

The lateral internal sphincterotomy (LIS) technique is considered the optimal surgical treatment for chronic anal fissures (CAFs); however, questions remain regarding the best technique. The present study investigated whether the type of anoderm incision (vertical or parallel to the anus) affected wound healing, wound-related complications, incontinence and recurrence rates in CAF patients undergoing open LIS.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing open lateral internal sphincterotomy for chronic anal fissure

Exclusion Criteria:

* Younger than 18 and older than 65 years of age, patients who had undergone no previous medical treatment, patients with a history of perianal interventions, patients with inflammatory bowel disease, diabetic patients, patients on steroids and immunosuppressives, patients with collagen tissue diseases, mentally retarded patients and patients with malignant disorders.
Evaluation of Two Types of PRP in Knee Osteoarthritis

OOsteoarthritis (OA) is a chronic joint disease characterized by progressive degeneration of cartilage and bone tissue, leading to the appearance of subchondral cysts, osteophyte formation and synovial inflammation. Although the causes of OA are still poorly understood, biomechanical stresses able to reach the articular cartilage and subchondral bone, biochemical changes in cartilage and synovial membrane, as well as genetic factors are important items in its pathogenesis. Although there is no cure for OA, treatment is directed to each individual patient, seeking to minimize pain, maintain or improve joint range of motion and limit disability. New therapies able to accelerate regeneration and tissue repair process are being discussed. The viscosupplementation with hyaluronic acid (HA) have been shown to be an effective and safe treatment alternative in the fight against knee OA, in addition to HA, worth highlighting the therapeutic effects of growth factors derived from autologous platelets. The platelet-rich plasma (PRP) appears as an autologous therapy, non-immunogenic, able to induce healing and repair of bone soft tissue. This study aims to evaluate the clinical efficacy, comparing treatment with PRP and the combination of HA and PRP in the treatment of knee OA. To this, 120 will be selected OA patients with mild, moderate and severe (Grade II, III and IV). Selected patients will be scheduled for the procedures and randomly assigned randomly. In PRP be determined concentrations of the growth factor PDGF, TGFb 1, VEGF, EGF, by the method Bio Plex®.\\. Functional evaluations will be conducted through questionnaires (WOMAC and SF-36) as measures of function and quality of self-reported life. The walking and strength test will be performed before and during periods of 90.180 and 360 days after the first application. The main motivation for the development of this study is the lack of randomized, double-blind clinical studies in the literature, and also based on the favorable results researchers have obtained, both with the use of HA, as the use of PRP in accelerating the process scar, preventing the development of arthrosis above. Therefore, we believe that the PRP, with its growth factors associated with synthetic HA play a synergistic action that should be studied in detail, in order to establish an effective therapeutic approach in the treatment of patients with knee OA.


Eligibility Criteria:
Inclusion Criteria:

Patients with Osteoarthrits

Exclusion Criteria:

* diabetes, rheumatoid arthritis, axial deviation (varus\> 10 degrees valgus\> 10 degrees), blood disorders (coagulopathy and platelet changes), cardiovascular diseases, infections, immunosuppression, patients on anticoagulant therapy or antiplatelet use of nonsteroidal anti-inflammatory 5 days before blood collection, patients with hemoglobin concentrations \<11 and platelet count \<150,000 mm³.
A Study of HH-120 Nasal Spray in Close Contacts of Those Diagnosed With COVID-19

This study is to evaluate the efficacy of post-exposure prevention and safety of HH-120 nasal spray in participants who are caregivers of hospitalized patients infected with SARS-CoV-2. HH-120 nasal spray are administrated 8-10 times to the participants per day until the discharge of the SARS-CoV-2 infected patients or confirmed infection of the participant, whichever occurs first.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects aged 18 or above;
* Caregivers of hospitalized children who are infected with SARS-CoV-2;
* Negative qRT-PCR nucleic acid test result during the screening;
* Willing and able to give written informed consent.

Exclusion Criteria:

* Those who have child-bearing plan or are unable to voluntarily take effective contraceptive measures, or plan to donate sperm/ovum during the study or within 3 months after the end of the study;
* Female subjects who are positive for human chorionic gonadotropin (β-Human Chorionic Gonadotropin, β-HCG) or are breastfeeding;
* Have used antiviral drugs with a therapeutic effect on COVID-19 within 3 months before screening, including various monoclonal antibodies (tixagevimab and cilgavimab, tocilizumab, ambavirumab and romisvir, Bamlanivimab, Etesevimab, Bebtelovimab, Casirivimab and imdevimab, Sotrovimab), convalescent plasma, hydroxychloroquine, Paxlovid (Nimatevir/ritonavir), Azvudine, Baricitinib, molnupiravir, remdesivir, interference drug, ribavirin, arbidol and lopinavir, etc.; (except those with the wash-out time longer than 5 half-lives);
* Those who have participated in clinical trials of SARS-CoV-2 neutralizing antibodies or participated in clinical trials of other drugs within 4 weeks before screening;
* Those who have a history of severe allergies or are sensitive to inhaled allergens; or are known to be sensitive to the ingredients of the study drug, other monoclonal antibody drugs, and therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokines, interleukin, etc.) Factors, etc.) have allergies or hypersensitivity reactions;
* Those who have received the COVID-19 vaccine within 2 weeks before the study drug administration or plan to receive the COVID-19 vaccine during the study;
* Those who cannot tolerate with nasal spray treatment;
* Any other circumstances that the researchers deemed not suitable for participating in the study.
Destination Therapy Post Approval Study

Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice.

The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product Surveillance Platform.

The HeartWare Destination Therapy (DT) Post Approval Study (PAS) is a prospective, observational, multi-site study. Enrollment into the DT PAS will be comprised of newly enrolled, commercial use DT patients with the HeartWare Ventricular Assist Device System (HVAD System). Patients enrolled in DT PAS will be followed for 5 years post-implant or until study closure, patient death, patient exit from the PAS (i.e., withdrawal of consent), or patient has HVAD device removed without replacement (i.e., transplant, recovery) or device is exchanged for non-HVAD. The total estimated study duration is approximately 7 years.

Eligibility Criteria:
Inclusion Criteria:

* Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
* Patient is intended to receive or be treated with a HeartWare HVAD System for use as destination therapy
* Patient is consented prior to the HVAD implant procedure

Exclusion Criteria:

* Patient who is, or is expected to be inaccessible for follow-up
* Patient with exclusion criteria required by local law
* Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and or effectiveness)
* Patient less than 18 years of age.
* Patient with previous support by long-term mechanical circulatory support (MCS), not including temporary mechanical circulatory support.
Sinovac, Pandemic Influenza A/H1N1 Vaccine in 6 to 35 Months Infants

A single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of Sinovac's influenza A/H1N1 Vaccine (PANFLU.1).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female aged between 6 and 35 months
2. Full-term birth, birth weight 2,500 grams or more
3. provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent

Exclusion Criteria:

1. Cases, cured cases and close contact of influenza A (H1N1) virus
2. Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc
3. Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
4. Symptoms of acute infection within a week
5. Autoimmune disease or immunodeficiency
6. Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
7. Asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids
8. Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
9. History or family history of convulsions, epilepsy, brain disease and psychiatric
10. Asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen
11. Guillain-Barre Syndrome
12. Administration of 2009-2010 seasonal vaccine
13. History of any blood products within 3 months
14. Administration of any other investigational research agents within 30 days
15. Administration of any live attenuated vaccine within 30 days
16. Administration of subunit or inactivated vaccines within 14 days
17. Be receiving anti-TB prophylaxis or therapy currently
18. Axillary temperature \> 37.0 centigrade at the time of dosing
19. Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Evaluation of the Mechanism of Action of Platelet Rich Fibrin Matrix (PRFM) in Producing Skin Volume Augmentation

Autologous platelet rich fibrin matrix will release growth factors which could increase the production of dermal proteins or affect the vascularity and status of neighboring tissues. This study is designed to evaluate the histologic and biochemical effect of injection of platelet rich fibrin matrix into the skin.

Subjects will be treated with platelet rich fibrin matrix into the skin of the inner aspect of the upper arm. Injected areas will be monitored clinically and will also undergo biopsies between 30 minutes and 12 weeks after treatment. Specimen of treated areas will undergo histologic and biochemical analysis and comparison to standard laboratory control specimen of untreated skin.

Eligibility Criteria:
Inclusion Criteria:

* 25 and 75 years of age

Exclusion Criteria:

* collagen vascular disorders
* autoimmune diseases
* signs or history of impaired wound healing
* shall not have had any infectious or inflammatory processes at the treatment sites within the prior 6 months
Poor Responders Infertile Patients -A Great Clinical Challenge

infertile , poor responders patients who underwent ICSI. The participants were divided into 2 groups according to the starting dose of Gn stimulation. Group I started with 4 ampoules while group II started with 6 ampoules

Participants will be randomized to start induction with 4 or 6 ampoules of gonadotropins from day 2 till the day of human chorionic gonadotropin (HCG), dose adjusted according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by TVUS scan daily or on alternate days according to the ovarian response to treatment starting on treatment cycle day 6 for folliculometry and endometrial thickness and pattern. Cetrotide (MerckSerono, Germany) 0.25 subcutaneously will be added when the leading follicle (DF) reaches \>12 mm and HCG 10 000 IU intramuscularly (Pregnyl, Merck Sharp, United Kingdom)will be given only if we have at least 3 mature follicles \>14 mm and the leading one \>17 mm; then, ovum pickup (OPU) was done after 36 hours of HCG and metaphase II ocytes were analyzed. The intracytoplasmic sperm injection (ICSI) procedure will be performed in all cases to avoid low fertilization rate by conventional IVF. Fertilization was assessed 16 to 18 hours after ICSI, and embryo quality will be evaluated 2 and 3 days after ICSI according to the number of blastomeres and the degree of fragmentation and multinucleation. Oocytes were collected and embryos will be cultured in ISM1 culture medium (Origiomedicult media, Denmark). Transfer of cleaving embryos will be done on day 3 after oocyte retrieval (using Labotect semirigid catheter; labotect GmbH, Germany), when the woman has at least 1 embryo (GI) otherwise canceled embryo transfer (ET). The ET was done by 1 person in each center. Both of the transferring consultants have more than 5 years experience in IVF unit. . All patients will receive luteal support in the form of daily progesterone cyclogest (Actavis, United Kingdom) 800 mg daily starting from day of ovum retrieval till day of hCG testing. Serum b hCG level was assessed on day 14 after ET and considered positive if \>5 mIU/ml. The TVUS was performed 28 days after ET to confirm ongoing pregnancy by visualization of intrauterine sac.

Eligibility Criteria:
Inclusion Criteria:

* Poor responders according to "Bologna consensus" with at least 2 of the following 3 points should be present:

  1. Age \>40 years or other cause of poor function.
  2. AFC\<2-5 in both ovaries or AMH \< 0.5-1.1 ng/dl 2)
  3. History of poor response with conventional stimulation protocol

Exclusion Criteria:

1. Uterine factor.
2. Severe male factor.
3. Endometriosis.
Mechanisms of Dyspnea Relief During Exercise in COPD Patients Following Treatment With Tiotropium (Spiriva)

To explore the mechanisms of dyspnea relief during exercise in patients with COPD following treatment with tiotropium bromide (Spiriva)

This was a single-centre, randomised, double-blind, placebo-controlled, cross-over study. The duration of subject participation was 9 weeks. There was an initial screening period of up to 2 weeks. The first screening visit consisted of medical history, clinical assessment, chronic dyspnea evaluation, complete pulmonary function testing, and a symptom-limited maximal incremental cycle exercise test. A second visit during the screening period was intended as a training of the subject to the procedures to be performed in the study, with specific focus on familiarisation with the constant work rate exercise test. The screening period was followed by 2 x 7 day treatment periods (1 x tiotropium and 1 x placebo), separated by a 4 week washout period. On the last day of each treatment period, the subject visited the clinic to complete a series of trial related procedures, including lung function measurements and a constant work rate exercise test at 75% Wcap to symptom limitation. Testing consisted of pulmonary function testing, dyspnea evaluation, and symptom-limited constant-load cycle exercise tests with measurements of cardiopulmonary parameters, symptom intensity and pulmonary mechanics. \\

Study Hypothesis:

Dynamic hyperinflation restricts volume expansion during exercise and is suspected as a primary mechanism of dyspnea. The dissociation between drive or muscular effort to breathe and the mechanical response to increased volume (as reflected by an increased Pes/PImax: VT/predicted VC ratio) correlates well with the intensity of inspiratory difficulty during exercise in COPD. It was hypothesised that reduced Borg ratings at a standardized exercise level after tiotropium would correlate strongly with reduced restricted volume expansion during exercise (i.e., increased VT/IC and EILV/TLC ratios, and decreased IC and IRV). In other words, dyspnea and its predominant qualitative dimensions (i.e., inspiratory difficulty) result from patients being forced by DH to breathe at a high lung volume, at or above predicted TLC.

Comparison(s):

tiotropium bromide (Spiriva) vs. placebo

Eligibility Criteria:
Inclusion criteria: Patients with chronic obstructive pulmonary disease (COPD) with FEV1 \< 70% predicted and FRC \> 120% predicted, a cigarette smoking history \> 20 pack-years, and moderate to severe chronic dyspnea

Exclusion criteria: patients with a history of asthma, allergic rhinitis or atopy; patients who participated in a rehabilitation program for COPD within 6 weeks prior to screening
Mifepristone and Misoprostol for the Termination of Pregnancy up to 70 Days Gestation

The purpose of this study is to determine the efficacy and acceptability of a regimen of 200 mg mifepristone (Zacafemyl), followed 24-48 hours later by 800 mcg of buccal misoprostol.

In Mexico City, the registration of a new mifepristone product signals a new wave in the SSDF's program for terminating pregnancies up to 70 days. This study evaluates the efficacy of the product Zacafemyl for the termination of pregnancy up to 70 days LMP. It also evaluates the incidence and acceptability of side effects of the medication and regimen. Participants are women of reproductive age with a gestational age of less than or equal to 70 days who want and are eligible for medical abortion, are willing and able to provide all follow up information, and have no contraindications.

Women who are eligible and consent to enroll in the study will be given 200 mg of mifepristone orally in the clinic. The participants will then be given 800 mcg of misoprostol (four 200 mcg tablets) to take home and instructed to take two tablets bucally 24-48 hours after the mifepristone and the remaining tablets within 30 minutes. They will be warned of the side effects they may experience.

All participants will be informed that they can call the clinic in case they have questions about the symptoms or side effects or if they have other concerns. They will also be told that they can return to the clinic in case of severe or persistent bleeding, or if they decide at any point that they want surgical intervention. Participants will also be informed as to the signs of pregnancy termination.

Seven days after taking the mifepristone (the eighth day of the study) the woman should return to the clinic for follow up. Information will be collected on a series of six semi-structured forms that are filled out by members of the study team in accordance with the responses of the participants to the interview questions and the results of physical exams, ultrasounds, etc. Analyses of the data will focus on efficacy, acceptability, side effects, and adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Women of reproductive age
* Gestational age less than or equal to 70 days LMP
* Willing and capable of accepting and participating
* Eligible for medical abortion according to the clinic's evaluation
* Willing to undergo a surgical intervention to complete the abortion if necessary
* Willing to provide an address and/or telephone number for follow up
* Have easy, straightforward access to a telephone and emergency transport

Exclusion Criteria:

* Gestational age is greater than 70 days LMP
* Suspicion or diagnosis of ectopic pregnancy or undiagnosed adnexal mass
* Use of IUD (note: the woman will be eligible when she removes the IUD)
* Chronic renal failure
* Current long term treatment with corticosteroids
* Allergy to mifepristone, misoprostol, or other prostaglandin
* Coagulopathies or current treatment with anti-coagulants
* Hereditary porphyrias