cyrilzakka/clinical-trials huggingface dataset:
Prospective Clinical Investigation Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy

Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy

A prospective, randomized, controlled, multicenter non-inferiority study comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy. Patients will be enrolled for 90 Days from day of Surgery. It is expected that it will take 6-9 months for the full duration of the study including the 90 day follow up period.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age;
2. Provide signed and dated informed consent form;
3. Willing to comply with all study procedures, schedules and be available for the follow-up evaluations for the duration of the study;
4. Willing to follow instructions for incision care and follow guidelines related to resumption of daily activities;
5. Agree not to schedule any additional elective surgical procedures that involve an incision until their participation in this study is complete;
6. In good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history, and review of recent concomitant medications;
7. Requiring a mastectomy (standard, modified, modified radical) with or without sentinel node biopsy;
8. ≤ ASA 3 - American Society of Anesthesiologists Physical Classification System

Exclusion Criteria:

1. Pregnancy or lactation;
2. Known medical condition that results in compromised blood supply to tissues;
3. Known or suspected allergy or sensitivity to any test materials or reagents;
4. Any condition known to affect wound healing, such as collagen vascular disease;
5. Receiving antibiotic therapy for pre-existing condition or infection;
6. Planned immediate breast reconstruction;
7. Concurrent use of fibrin sealants or other internal wound care devices;
8. Unable to understand questions, instructions or the informed consent presentation in the language of the investigators performing the study;
9. Requiring a mastectomy with ALND (as determined at time of surgery);
10. Be participating in any conflicting medical device clinical trial within 30 days of enrollment in this study.
Biofunctionalization of a Volume-stable Collagen Matrix (VCMX) for the Treatment of Single Gingival Recession

The treatment of single gingival recessions comprises different well-established techniques, and the association between coronally advanced flap (CAF) and the subepithelial connective tissue graft is considered the gold standard. However, despite the excellent clinical results obtained, the use of subepithelial connective tissue graft is related to an increased risk of trans and postoperative bleeding, a longer duration of the surgical procedure and greater postoperative pain and morbidity. To overcome these limitations and increase patient acceptance, new biomaterials have been developed as possible alternatives to the use of connective tissue graft. Recently, tissue engineering has been investigating collagen matrices as carriers of biologically active substances. In vitro and in vivo studies have shown that the biofunctionalization of these matrices using injectable platelet rich-fibrin (i-PRF) can optimize the healing process of soft tissues using own's patient regenerative components. However, although it has promising potential, clinical studies evaluating the performance of functionalized collagen matrices are still scarce in the literature. Thus, the present study aims to evaluate the clinical, esthetic, patient-centered, immuno and microbiological results of the use of the biofunctionalized volume stable collagen matrix (VCMX) for the treatment of single gingival recessions RT1. For such purpose, a randomized controlled clinical trial of superiority, parallel and blind will be carried out. Seventy-five patients with RT1 single gingival recession will be selected, who will be randomly allocated to one of the following groups: CAF+VCMX+i-PRF (n = 25), coronally advanced flap associated with VCMX functionalized with i-PRF; CAF+VCMX (n=25), coronally advanced flap associated with VCMX; and CAF group (n = 25), coronally advanced flap alone (CAF). The groups will be compared regarding clinical, esthetic and patient-centered outcomes at the baseline, three and six months after the surgical procedure. The microbiological evaluation will be performed at baseline, three and six months after surgery and the concentration of inflammatory markers and growth factors will be assessed before the procedure and 3, 7, 14, 30 and 60 days after treatment.


Eligibility Criteria:
Inclusion Criteria:

* Presence of RT1 (Cairo et al., 2011) buccal single gingival recession (GR) on vital upper or lower canines and premolars with intact root surface (visible CEJ).
* Presence of dentin hypersensitivity (HD) and/or esthetic concerns related to GR.
* Adults \> 18 years old.
* Systemically health.
* No signs of active periodontal disease.
* Full-mouth plaque and bleeding score ≤ 20%.
* Written informed consent given.

Exclusion Criteria:

* Smoking.
* Contraindication for periodontal surgery.
* Pregnancy.
* Presence of orthodontic braces.
* Medications known to interfere with periodontal healing.
* Use of anticoagulants.
The Prevalence of Semicircular Canal Dysfunction Among Rehabilitation Patients

Patients hospitalized at the rehabilitation department at the hospital will fill a questionnaire regarding dizziness and ear diseases, and the Dizziness Handicap Inventory, and then will be examined by an ENT physician, followed by a video Head Impulse Test (vHIT) study.


Eligibility Criteria:
Inclusion Criteria:

* Over 65 years old
* Hospitalized at the rehabilitation department

Exclusion Criteria:

* Blindness or loss of vision which is not corrected using glasses
* Past CVA with neurological remnants
* Movement disorder
* Lower body part weakness
* Limitation in neck movement
* Vestibular pathology diagnosed in the past 6 months
Zika-Vaccine Dose Finding Study Regarding Safety, Immunogenicity and Tolerability (V186-001)

Double blinded, randomized, placebo-controlled, dose finding, multi-center, phase 1 trial in 48 healthy volunteer subjects.

After completion of screening procedures, the subjects are randomized to one of four treatment groups (different dosage strengths and placebo) All subjects will receive study treatment at day 0 and will return on day 28. Subjects randomized to treatment groups with two vaccinations will receive a second treatment at day 28.

Subjects will return on day 56 for the final visit.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers aged 18 to 55
* subjects of child bearing potential must perform reliable method of contraception

Exclusion Criteria:

* immune deficiency, history of HIV, HBV, HCV
* drug addiction
* vaccination within 4 weeks prior to study or planned vaccination during study
* prior receipt of any Zika vaccine
* recent infection 1 week prior to screening
* relevant medical history interfering with aim of study
* neoplastic disease, hematological malignancy
* history of autoimmune disease
* psychological condition that affects ability to participate in the study
* history of severe adverse reactions to vaccine administration
* history of anaphylaxis
* allergic reactions, abnormal lab values, or concomitant medication per decision of the investigator
* use of immunosuppressive drugs within 30 days before screening or planned use during study
* receipt of blood products within 120 days before screening or planned use during study
* pregnancy, unreliable contraception method
* decision of the investigator
* regular blood plasma donor
CAR T-cells Against CD30 (HSP-CAR30) for Relapsed/ Refractory Hodgkin and T-cell Lymphoma.

HSP-CAR30 is a cell suspension of genetically modified T-cells to express a second generation (4-1BBz) chimeric antigen receptor (CAR) directed against CD30.

This is a phase I/IIa, interventional, single arm, open label, treatment study to evaluate the safety, tolerability and efficacy of HSP-CAR30 in patients with relapsed/refractory Hodgkin lymphoma and relapsed/refractory T-cell lymphoma expressing CD30.


Eligibility Criteria:
Inclusion Criteria:

* Classic Hodgkin lymphoma:

  * Relapsed patients after autologous hematopoietic stem cell transplantation who have already received Brentuximab-Vedotin and anti-PDL1 antibodies, OR
  * Primarily refractory patients who do not reach CR after rescue, including Brentuximab-Vedotin and anti-PDL1 antibodies.
* Anaplastic large T-cell lymphoma (ALK+/ALK-) and peripheral T-cell lymphoma (NOS/Angioimmunoblastic):

  * \>90% of tumor cells expressing CD30 determined by immunohistochemistry, AND
  * Relapsed patients after autologous hematopoietic stem cell transplantation, OR
  * Primarily refractory patients (after first line, including anthracycline) who do not achieve CR after rescue.
  * All patients must sign an informed consent before starting any procedure.
  * All patients must have measurable disease (detected by PET-CT) at the time of inclusion.
  * Performance status: ECOG 0-1
  * FEV1\> 39%; DLCO and FVC\> 39% of NV.
  * No significant ventricular dysfunction: EF \>45%.
  * Total bilirubin and transaminases \<3 times the maximum normal value, unless attributable to lymphoma.
  * Creatinine \<2 times the normal maximum value and clearance\> 40 mL/min.

Exclusion Criteria:

* Performance status: ECOG 2-4
* Prior allogeneic haematopoietic stem cell transplant.
* Active hepatitis B, C or HIV infection
* Active bacterial, fungal, or viral infection.
* Evidence of CNS involvement by lymphoma.
Pilot Evaluation of a Walking School Bus Program

Walking to school is one of the objectives for children and adolescents in Healthy People 2010 and in previous studies was associated with higher levels of overall physical activity, which has been shown to decrease obesity. Therefore, more children walking to school should result in increased physical activity and presumably reduce obesity. However, increasing child pedestrian activity could increase the risk of child pedestrian injuries. Walking with an adult who provides instruction in pedestrian skills and monitors the child's actual behavior may be the most important component of a successful intervention. Walking with an adult reduced child pedestrian injury risk by almost 70%. A walking school bus (WSB) addresses safety concerns by providing a period of physical activity supervised by several responsible adults and teaching opportunities around pedestrian safety skills on the way to and from school. Children may join the WSB at various points along the set route. Despite the growing popularity of WSB programs in the United States, randomized, controlled-studies are lacking that examine the impact on children's safety, physical activity, and health. We seek to help fill this gap in the literature by piloting a WSB program in elementary schools in the Houston Independent School District to test feasibility. We hypothesize that a WSB program will: (1) increase the number of students walking to school and decrease the number of students driven to school by car, (2) increase students' pedestrian safety behaviors (3) increase students' physical activity, and (4) decrease students' excess weight gain.


Eligibility Criteria:
Inclusion Criteria:

* 4th grade student at a study school in the Houston Independent School District
* Must be physically able to walk to and from school

Exclusion Criteria:

* Any condition that would prevent the student from walking to or from school
Observation of Cough Variant Asthma Treated in Combination of Chanqin Granules.

This single-center, randomized, double-blind, placebo-controlled trial was undertaken at an outpatient clinic in Shuguang Hospital. Newly diagnosed cough variant asthma adult patients with the T.C.M. pattern of pathogenic-wind are randomly divided into treatment and control group, with 60 patients in each group. Clinical observation of the Respiratory Impedance and Inflammation in Cough Variant Asthma adults reated in Combination of Chanqin Granules.

This single-center, randomized, double-blind, placebo-controlled trial was undertaken at an outpatient clinic in Shuguang Hospital. Newly diagnosed cough variant asthma adult patients with the T.C.M. pattern of pathogenic-wind are randomly divided into treatment and control group, with 60 patients in each group. All patients enrolled are treated with Budesonide + Formoterol Fumarate dry power (160/4.5ug bid) for inhalation. The treatment group are given additional Chanqin granulate (10g bid) and placebo granulate for controlled group. Investigators hypothesis that Chanqin granules may reduce day \& night cough score as well as the respiratory impedance, inflammation statues, and improve T.C.M. syndrome after 8 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of cough variant asthma according to Western medicine
2. Diagnosis of cough with pathogenic wind syndrome according to TCM
3. Aged between 18 to 70 years, regardless of gender, race or educational and economic status
4. The cough symptom should last for at least 8 weeks

4. Willingness to participate and to sign the informed consent form

Exclusion Criteria:

1. Patients with history of smoking (or quite smoking for less than 6 months)
2. Systemic use of corticosteroids in the past 4 weeks
3. Upper or lower respiratory tract infection in the past 4 weeks
4. Incapable of corporation with spirometry and FeNO test
5. Other chronic respiratory disease eg: COPD, pulmonary cirrhosis
6. Women who are pregnant or preparing to become pregnant or breast feeding women
Efficacy Study of Iferanserin to Treat Hemorrhoids

To evaluate the safety and efficacy of topical 0.5% S-MPEC cream vs. placebo cream (applied twice daily for 14 days) in the treatment of Grade I - III hemorrhoids.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Diagnosis of grade I - III hemorrhoids with bleeding episodes of at least every other day during the last two weeks before enrollment in the study.
* Patients signing the Informed Consent form.

Exclusion Criteria:

* Patients with protruding or irreducible hemorrhoids (grade IV).
* Patients with anal fistulas, periproctitis or hemorrhagic diathesis
* Patients with current history of Type I or Type II diabetes mellitus.
* Patients with severe hepatic, renal or cardiovascular disorders.
* Patients with any type of infectious disease.
* Patients who have been involved with another experimental drug trial within the past 30 days.
* Patients presently diagnosed with cancer.
* Patients who have known alcohol and drug abuse.
* Patients who require the use of suppositories.
* Patients with blood or urine laboratory values outside the normal limits or those with values considered abnormal in the opinion of the investigator.
Combined Effects of Nutritional and Exercise Countermeasures

The purpose of this study is to see if a combination of resistance exercises and amino acid capsules can reduce muscle loss and maintain muscle function during bedrest. This experiment will imitate many of the physical conditions experienced by astronauts during space flight by examining the effects of resistance exercise or nutrition on muscle during 2 days of bedrest. The diet of astronauts will also be imitated by providing diets in the General Clinic Research Center.


Eligibility Criteria:
Inclusion Criteria:

* 18-50 years of age
* Availability of transport and ability to report to Research Center at appointed times

Exclusion Criteria:

* Subjects with limiting or unstable angina or a cardiology confirmed ECG which demonstrates cardiac abnormalities such as \> 0.2 mV horizontal or downsloping ST segment depression, frequent arrhythmia's (\>10 PVC/min), or valvular disease.
* Subjects with vascular disease as determined by a combination of risk factors of peripheral atherosclerosis, namely hypertension, obesity, diabetes, hypercholesterolemia and/or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal, and pedal arteries.
* Any history of hypo- or hyper-coagulation disorders including subjects taking Coumadin or with a history of DVT or PE at any point in their lifetime.
* Any subject that has a chronically elevated systolic pressure \>170 or a diastolic blood pressure \> 100 will be excluded. Subjects may be included if they are taking blood pressure medication and have a blood pressure below these criteria.
* Any subject with an uncontrolled metabolic disease including liver or renal disease.
* Fasting blood glucose of \>126 mg/dl on two separate occasions
* Presence of acute illness or metabolically unstable chronic illness.
* Any subject currently on weight-loss diet.
* Inability to abstain from smoking for duration of study.
* Recent ingestion of anabolic steroids (within 6 months).
* Subjects with atrial fibrillation, history of syncope, angina or congestive heart failure.
* Subjects with a recently (6 months) treated cancer other than Basal Cell Carcinoma.
* Pregnancy/lactation.
* Any other condition or event considered exclusionary by the PI and covering faculty
Cumulative Live Birth Rates in Dual Ovarian Stimulation Versus Two Antagonist Stimulations in Poor Ovarian Responders

To compare the difference in cumulative live birth rates between dual ovarian stimulation and two antagonist stimulations in poor ovarian responders.

Studies have shown the ability to obtain oocytes with equivalent quality from the follicular and the luteal phase, and a higher number of oocytes within one cycle when using dual ovarian stimulation (duostim). This could be particularly relevant for women with poor ovarian responders (POR). Whether the cumulative live birth rates differ after duostim and two antagonist stimulations in POR remains controversial.

Eligibility Criteria:
Inclusion Criteria:

* Women with POR were defined with adjusted Bologna criteria, at least two of the three following criteria: advanced maternal age (40 years); 3 oocytes in previous IVF; and antral follicle count (AFC) 5 and/or anti-Mu¨llerian hormone (AMH) 1.1 ng/ml (this criterion was mandatory)
* Aged from 20 to 44 years
* Body mass index (BMI) from 19 to 32 kg/m2
* No more than two previous IVF cycles were recruited

Exclusion Criteria:

* Amenorrhoea
* Follicle stimulating hormone (FSH) 20 IU/L or AFC 1
* Women with a partner with an extremely severe sperm anomaly or sperm donor use
Use of Narrative Voice and Introduction Content to Improve Interactive Voice Response Surveys in Bangladesh and Uganda

This study evaluates the effect of two different narrative voices (one male and one female) and two different introductions (one with informational content and the other with additional motivational content) on interactive voice response (IVR) survey cooperation, response, refusal, and contact rates, as compared to a control group (male, informational), in Bangladesh and Uganda.

Using random digit dialing (RDD) sampling techniques, participants were randomized to one of four arms: 1) male narrator and informational survey introduction, 2) male narrator and motivational survey introduction, 3) female narrator and informational survey introduction, and 4) female narrator and motivational survey introduction,male motivational, female informational, female motivational) which were then followed by a noncommunicable disease risk factor survey. This mobile phone survey was sent as an interactive voice response (IVR). In IVR surveys, participants use their touch tone key pad to answer pre-recorded questions. (i.e. If you are male, press 1; if you are female, press 2). This study was conducted in both Bangladesh and Uganda.

Eligibility Criteria:
Inclusion Criteria:

* Access to a mobile phone
* Greater or equal to 18 years of age
* In Bangladesh, conversant in either English or Bangla language. In Uganda, conversant in either Luo, Luganda, Runyakitara or English languages.

Exclusion Criteria:

* Less than 18 years of age
Safety and Efficacy Study of OMS721 in Patients With Thrombotic Microangiopathies

The purpose of this study is to assess the safety, efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of OMS721 in patients with thrombotic microangiopathies (TMA).

This is a Phase 2, uncontrolled, 3-stage, ascending-dose-escalation study in patients with 1 of 3 forms of TMA: atypical hemolytic uremic syndrome (aHUS), thrombotic thrombocytopenia (TTP), and hematopoietic stem cell transplant - associated TMA (HSCT-associated TMA). In Stage 1 of the study, OMS721 was administered to 3 cohorts, with dose escalation by cohort to identify the optimal dosing regimen. In Stage 2, the dose selected in the first stage was administered to expanded cohorts of patients with distinct etiologies (aHUS alone in 1 cohort and TTP or HSCT-TMA in the other cohort). Patients completing Stage 2 were eligible for continued treatment in Stage 3 if they tolerated OMS721 treatment and derived clinical benefit. Enrollment in the study has been completed.

Eligibility Criteria:
Inclusion Criteria:

1. Are at least age 18 at screening (Visit 1)
2. Have a diagnosis of primary aHUS, persistent HSCT-associated TMA or TTP
3. No clinically apparent alternative explanation for thrombocytopenia and anemia

Exclusion Criteria:

1. Had eculizumab therapy within three months prior to screening
2. Have STEC-HUS
3. Have a positive direct Coombs test
4. Have an active systemic bacterial or fungal infection requiring antimicrobial therapy (prophylactic antimicrobial therapy administered as standard of care is allowed)