cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Relationship Between Severity of Chronic Venous Obstruction and Venous Claudication

Assessment of the Relationship between Severity of Chronic Venous Obstruction and Venous Claudication

The postthrombotic syndrome (PTS) occurs in about 20-50% of patients after a deep Venous thrombosis and significantly affects the quality of life of patients. With the patency rates of 73-100% are achieved with endovascular procedures. At 58% of patient ulcer healing was achieved. Neglen et al. could a significant demonstrate an improvement in quality of life. Aim of the study: To show the influence of the increased inflow to venous Objectively review recanalization for patient symptoms and walking performance. Therefore, before and after venous interventions, to assess walking performance and pain-free Measure the walking distance of the patient on the treadmill and compare it to get a possible identifying relevant and/or significant changes.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with an obstruction in the femoral vein communis, V. iliaca externa, V. iliaca communis or V. cava inferior
2. Age: 18-80 years old
3. Signed informed consent form
4. Persons who are legally competent and mentally capable, to follow the instructions of the staff

Exclusion Criteria:

1. Patients under 18 years of age.
2. Patients who are unable to consent and/or not in are able to appreciate the nature, importance and scope of the study understand and give their consent in writing.
3. Persons acting by administrative or judicial order are housed in a facility
4. Patients who abuse drugs
5. Peripheral arterial disease stage IIb, III and IV -
Association Between Live Birth Rate and Serum Progesterone During Hormonal Replacement Therapy

Nowadays, frozen-thawed embryo transfers (FET) are expending. This practice avoids risk of ovarian hyperstimulation syndrome (OHSS), as well as allowing better synchronization between endometrium and embryo, which is fundamental for pregnancy.

There are several FET protocols, including hormonal replacement therapy cycle (HRT), which enable clinicians to adapt the day of embryo transfer.

However, increase in spontaneous miscarriages was observed with this latter protocol compared to fresh embryo transfers and the other endometrial preparations (natural and stimulated), in relation with the lack of physiological corpus luteum.

Then, Clinicians interrogate about measuring serum progesterone in order to adjust their treatment and/or transfer date. Various studies have shown thresholds below and/or above which pregnancy or live birth rate were lowered.

The main objective is to find a serum progesterone threshold on the day of embryo transfer above which live birth rate is increased. The secondary objectives are to analyze the factors associated with increased serum progesterone on the day of transfer, to analyze the miscarriage rate, and impact of change on luteal phase support on day 12.


Eligibility Criteria:
Inclusion Criteria:

* women between 18 and 43,
* having frozen-thawed single embryo transfer of a day-5 blastocyst with hormonal replacement therapy, with measurement of serum progesterone on the day of transfer

Exclusion Criteria:

* frozen-thawed transfer of a day-2 or -3 or -6 embryo,
* double embryo transfer,
* other protocol than HRT,
* patient without serum progesterone measurement on the day of transfer
Effectiveness of the Numerous Educational Strategy Interventions Seeking to Increase the Water Consume in Child

The current project seeks to evaluate the effectiveness of numerous educational strategy interventions to increase the percentage of water consumed among early elementary school students over a 1-year period.

A community intervention trial will be conducted at four public elementary schools of the Coyoacan Delegation in Mexico City. It will include healthy first graders during the 2017-2018 school year whose parents agree to participate through verbal informed consent and a signed privacy notice. These parents will complete a baseline 3-day beverage record (two weekdays and one weekend day). The four schools will be assigned to one of three groups: Group I will receive the educational strategy during the first grade; Group II will receive it during first and second grades; and Group III will receive it during the first, second, and third grades. All schools will have water dispensers inside the classrooms, and the children will receive a reusable 600-mL bottle so they are able to consume water on demand throughout the day. A second record of beverage consumption will be obtained by completing multiple interventions within each group, and a third record will be completed 1 year later.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children
* Both girls and boys
* Children whose parents agree to participation in the study through verbal informed consent
* Children whose parents sign a privacy notice

Exclusion Criteria:

* Children who present with any pathology that interferes with the free consumption of water or with the proper execution of the study
* Children for whom it is not possible to obtain a baseline record of beverage consumption
Safety Profile Following Inactivated COVID-19 Vaccine in Healthy Adults Aged >18 Years in Indonesia

The aim of this study is evaluating safety profile of COVID-19 Vaccine in healthy adults aged \>18 years in Indonesia.

To assess any serious systemic reaction within 30 minutes after COVID-19 vaccine immunization.

To assess systemic reaction after COVID-19 Vaccine immunization. To assess local reaction after COVID-19 Vaccine immunization. To assess any serious adverse event after COVID-19 Vaccine immunization.

Eligibility Criteria:
Inclusion Criteria:

* Clinically healthy adults aged \> 18 years.
* Subjects have been informed properly regarding the study and signed the informed consent form.
* Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

Exclusion Criteria:

* Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
* Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with thermometer).
* Women who are lactating, pregnant or planning to become pregnant during the study period.
* History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
* Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)).
* Subjects receive any vaccination within 1 month before and after IP immunization.
* Subjects plan to move from the study area before the end of study period.
Fast Food, Fatigue, and Inflammation

This double-blind, randomized crossover trial assessed inflammation and fatigue following a fast-food-type meal (saturated fat) compared to a healthier meal (monounsaturated fat) in breast cancer survivors and benign controls (women who had an initial abnormal test for breast cancer).


Eligibility Criteria:
Inclusion Criteria:

* We recruited a subset of a larger parent longitudinal observational study to participate in this study. Initially, participants were recruited following an abnormal mammogram, which resulted in either a malignant (cancer group) or benign (non-cancer control group) diagnosis.

Exclusion Criteria:

* A history of any prior cancer except basal or squamous cell, chronic obstructive pulmonary disease, evidence of liver or kidney failure, symptomatic ischemic heart disease, significant visual or auditory problems, cognitive impairment, major medical conditions involving the immune system such as diabetes, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, alcohol or drug abuse, marked and recurrent gastrointestinal problems, or regular use of medications with major immunological consequences, e.g., steroids.
A Study of Evaluating the Safety and Efficacy of ATG-010 in Relapsed/Refractory Diffuse Large B-Cell Lymphoma

This is an open-label, single arm, and registered study of ATG-010 in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma.

This is an open-label, single arm, and registered study. About 60 patients with relapsed/refractory DLBCL plan to be enrolled in about 10 study sites of the study. It is planned that at least 50% (\~30 patients) will have the GCB subtype of DLBCL. Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle. Patients should remain on the study treatment of ATG-010, until either PD or occurrence of unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

1. The patient must provide informed consent form (ICF) prior to the first screening procedure.
2. Age ≥18 years.
3. ECOG performance status of ≤ 2.
4. Patients should have estimated life expectancy of \>3 months at study entry.
5. Previously treated, pathologically confirmed de novo DLBCL, or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma).
6. Patients must have received at least 2 but no more than 5 previous systemic regimens for the treatment of their de novo or transformed DLBCL.
7. Documented clinical or radiographic evidence of progressive DLBCL prior to dosing.
8. Patients must have measurable disease per the revised criteria for response assessment of lymphoma (Cheson, 2014).
9. Patients must not be eligible for high-dose chemotherapy with autologous stem cell transplantation rescue.

Exclusion Criteria:

1. Patients who are pregnant or lactating.
2. DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma, composite lymphoma (Hodgkin's lymphoma +NHL), or DLBCL transformed from diseases other than indolent NHL or Richter's.
3. Primary mediastinal (thymic) large B-cell lymphoma.
4. Known central nervous system lymphoma or meningeal involvement.
5. Patients whose most recent systemic anticancer therapy include radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy other than glucocorticoids \< 6 weeks prior to first dose of study drug.
6. Patients who have not recovered to Grade ≤ 1 clinically significant adverse events, or to their baseline, from their most recent systemic anti-DLBCL therapy.
7. Patients with active graft-versus-host disease after allogeneic stem cell transplantation. At least 4 months must have elapsed since completion of allogeneic stem cell transplantation.
8. Major surgery within 2 weeks of first dose of study treatment of ATG-010.
9. Any life-threatening illness, medical condition or organ system dysfunction which, in the Investigator's opinion, could compromise the patient's safety.
10. Active hepatitis B virus or hepatitis C virus infection.
11. Known human immunodeficiency virus infection.
Telehealth Intervention for Ostomy Self-Management

Over one million individuals in the U.S. have ostomies. An ostomy is a surgical procedure that creates an opening in the abdominal wall that allows bodily waste (urinary or fecal) to pass through into an external pouch; in essence, it is the externalization of the gastrointestinal or urinary structures to the abdominal wall. For cancer, ostomies are most commonly placed for rectal cancers, followed by urinary bladder cancer. The health-related quality of life impact of an ostomy is tremendous and greater than many other cancer treatments. The goal of this study is to pilot-test a perioperative ostomy self-management telehealth intervention (Periop-OSMT) in patients with colorectal and bladder cancer and their family caregivers. Participants will receive seven group telehealth sessions before and after ostomy surgery. This pilot clinical trial will study the feasibility of the methods/interventions and determine the preliminary efficacy to support a larger confirmatory trial.

An ostomy is a disability that adversely affects the HRQOL of cancer survivors and their support persons/family caregivers (FCGs) at all phases of cancer survivorship. More than half of survivors experience stoma-related challenges such as pain, troublesome odor, skin problems around the stoma, and leakage. Ongoing problems include pouching care, travel out of the home (especially relevant for rural populations), social interactions, intimacy, and acceptance of/satisfaction with appearance. Studies document persistent challenges including sexuality, psychological problems, and interference with work, and recreation and sporting activities. The purpose of this study is to assess the feasibility of a perioperative ostomy self-management telehealth intervention (Periop-OSMT) and to determine the preliminary efficacy of the intervention on participant-reported outcomes, compared to the usual care arm. We hypothesize that the intervention will be feasible, acceptable and will demonstrate preliminary improvements in outcomes compared to the usual care arm.

Eligibility Criteria:
Patient Eligibility Criteria:

* Patient with bladder or colorectal cancer
* Scheduled to undergo a surgical procedure that includes the creation of an intestinal stoma (fecal or urinary, permanent or temporary)
* For bladder cancer, only patients with incontinent urostomies (ileal conduit) are eligible.
* Age: ≥ 18 years
* Ability to read and understand English for Questionnaires

Family Caregiver Eligibility Criteria:

* A family member or friend identified by the patient and defined as a person who knows the patient well and is involved in the patient's care before and after surgery
* Age: ≥ 18 years
* Ability to read and understand English for Questionnaires
* Pregnant FCGs are eligible for participation. Participation in this behavioral/educational intervention should not impact the pregnancy/fetus.
A Study of Doxorubicin in the Treatment of AIDS-Related Kaposi's Sarcoma

To study the natural course of AIDS related Kaposi's sarcoma and to determine the usefulness and safety of weekly administration of small doses of doxorubicin.

Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.

Doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. When small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.

Patients are stratified for non-therapy purposes into 2 groups; doxorubicin is given intravenously (IV) every week on an outpatient basis. Patients are monitored carefully, and weekly blood samples are taken to determine the effectiveness and safety of treatment. Patients are evaluated for toxicity after one dose of the drug and weekly thereafter. Patients are evaluated for response to the drug after 4 weeks and monthly thereafter.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Ongoing and/or maintenance therapy for opportunistic infection.
* Medications for nausea, vomiting, and diarrhea resulting from drug.

Patients must have AIDS related Kaposi's sarcoma.

* Patients may demonstrate positive blood cultures for Mycobacterium avium-complex or cytomegalovirus.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions will be excluded:

* Patients with active opportunistic infection.
* Patients with concurrent neoplasm other than squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
* Patients with significant neurologic, cardiac, or liver disease.

Concurrent Medication:

Excluded:

* Antiretroviral agents.
* Immunomodulators.
* Corticosteroids.
* Experimental drugs.

The following patients will be excluded from the study:

* Patients with lymphadenopathy alone and/or visceral disease alone secondary to Kaposi's sarcoma.

Prior Medication:

Excluded:

* Cytotoxic chemotherapy.
* Excluded within 30 days of study entry:
* Antiretroviral agents.
* Biologic modifiers.
* Corticosteroids.

Prior Treatment:

Excluded:

* Total body electron beam therapy.
* Excluded within 30 days of study entry:
* Radiation therapy.
CAD-CAM PEEK Framework for All-on-4 Implants

This study was conducted to evaluate the clinical peri-implant soft tissue changes during the first year after occlusal loading and the ridge base relation after 3 years for mandibular computer-aided design and computer-aided manufacturing (CAD/CAM) screw-retained implant-supported hybrid prosthesis of polyetheretherketone (PEEK) framework utilized with All-on-Four treatment concept.

Sixteen completely edentulous patients were rehabilitated by four implants following the All-on-Four protocol. After 3 months, the definitive prosthesis was constructed to be a screw-retained CAD-CAM milled framework from the modified PEEK (BioHPP), bonded to polymethylmethacrylate teeth and a pink-shaded indirect light-polymerized nano-filled composite resin imitating the soft tissues. Peri-implant soft tissue changes regarding plaque, bleeding, gingival scores, and probing depth were evaluated at prosthesis insertion (T0), 6 months (T1), and 12 months (T2) after insertion. Also, monitoring of the ridge base relation was performed using cone-beam computed tomography CBCT at the time of insertion (T0), and 1 year (T1), 2 years (T2), and 3 years (T3) after mandibular fixed detachable All-on-Four framework insertion.

Eligibility Criteria:
Inclusion Criteria:

* Completely edentulous maxillary and mandibular ridges with sufficient mandibular bone height in the inter-foraminal area confirmed with panoramic x-rays.
* All selected patients will be with sufficient inter-arch space and restorative space.
* All selected patients will have apparently healthy ridge covered by compressible oral mucosa and free from any ridge flabbiness.

Exclusion Criteria:

* Patients with systemic diseases that contraindicate implant placement such as hematologic diseases, serious problems of coagulation and diseases of the immune system. Also, metabolic diseases related to bone resorption such as uncontrolled diabetics or osteoporosis will be also excluded
* History of para-functional habits (Bruxism, clenching), smoking and alcoholism.
* History of radiation therapy in the head and neck region.
Preemptive Analgesia for Postlaminectomy

To relieve post laminectomy pain, we have tried intraoperative perineural injection of lidocaine right after the exposure in expecting that this would be preemptive analgesia by blocking the nerve transmission so that postoperative pain starts later and lighter.

A randomized double-blind 40 patients aged 18-50 of ASA I and II undergoing laminectomy were included in the study. All the patients were followed for their heart rate, arterial pressure , respiratory rate, oxygen saturation, end tidal CO2 and postoperative VAS scores.

All the patients were premedicated with midazolam 0.1 mg/kg intramuscularly 40 minutes prior to surgery. The induction was made 2 mg/kg propofol, 1 ug/kg remifentanyl, 0.5mg/kg rocuronium. After the orotracheal intubation anesthesia was maintained with isoflurane (%0.5-2.0) and 0.1 mg/kg rocuronium.Just before the exposure of dorsal root, 0.5 cc %2 lidocaine was injected on the dorsal root.The patients postoperative analgesic period, VAS scores and additional analgesic need was recorded. For the postoperative analgesia tramadol 1 mg/kg tramadol was used.

Eligibility Criteria:
Inclusion Criteria:

* laminectomy
* 18-50 age
* ASA 1-2
* both sex

Exclusion Criteria:

* under 18 or older than 50
* any disease other than back pain\\
* ASA 3-4
The Role of Central Neck Dissection in Stage N0 Papillary Thyroid Carcinoma

The benefits of prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC). This study main goal is to investigate benefits of prophylactic central neck dissection in clinically node-negative papillary thyroid carcinoma.

Papillary thyroid carcinoma (PTC) is the most common type of differentiated thyroid carcinoma. Recurrence rate is still high. The standard management is total thyroidectomy. regional lymph node metastasis is noted in recurrent cases. Some studies stated benefits of central neck dissection in orevention of recurrence and others said there is no benefits. so prophylactic central neck dissection (pCND) remain controversial in clinically node-negative (cN0) papillary thyroid carcinoma (PTC).

Eligibility Criteria:
Inclusion Criteria:

* patients with papillary thyroid cancer with clinically node negative.

Exclusion Criteria:

* patients with clinical evidence of nodal metastases.
* patients with a previous history of thyroidectomy.
* patients with mixed-type papillary thyroid cancer.
Intraoperative Brain Shift Calculation Study

The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.

Brain shift is the main natural cause of major navigation imprecision. Despite numerous attempts no trials showed a possibility to calculate and predict it's value although some patterns were found. Some modern navigational features allow to partially resolve this problem. Manual shift correction allows to displace brain structures but can only be used if brain shift is linear. Intraoperative computed tomography (CT) and magnetic resonance imaging (MRI) allow to update navigational data but violate surgical workflow and cannot display brain tissue in real time. Intraoperative sonography has poorer quality, limited observe volume and lengthy learning curve.

The purpose of the study is to calculate magnitude, type of intraoperative brain shift and assess possibility of it's prediction.

For each patient a surgeon intraoperatively will assess location of brain surface, various intracranial structures and lesion margins during surgery. Postoperatively these data will be compared to lesion's characteristics, patient's state and intraoperative features.

Eligibility Criteria:
Inclusion Criteria:

* all intracranial tumors
* cavernomas
* arteriovenous malformations
* spontaneous (non-traumatic) intracerebral hemorrhages
* traumatic intracerebral hemorrhages
* supratentorial localization
* newly diagnosed
* age 18-100 years
* stable hemodynamics
* error of patient registration in neuronavigation no more than 2 mm

Exclusion Criteria:

* rapid cerebral dislocation