cyrilzakka/clinical-trials huggingface dataset:
Group Antenatal Care: The Power of Peers for Increasing Skilled Birth Attendance in Achham, Nepal

In rural Nepal, the major drivers of underutilization of skilled birth attendance are poverty, poor social support and inadequate birth planning. Drawing from similar programs that have been shown to improve maternal and neonatal outcomes, we have designed a group antenatal care program that uses a participatory learning and action process to engage women in identifying and solving problems accessing maternity care services and create a supportive social network. We plan to test a group antenatal care program that will change antenatal care in three major ways: 1) conduct care in a group setting with women matched by gestational age, 2) incorporate participatory learning and action, and 3) provide expert and facilitated peer counseling.

The group antenatal care intervention aims to improve rates of institutional birth and ANC care completion via improving acceptability of group care, maternal and neonatal health knowledge, self-efficacy, social support, and birth planning.

Objective 1: Assess the effect of group antenatal care on institutional birth rates through a prospective study using community household census data. Secondary outcomes will be completion of basic ANC package; neonatal mortality rate; percentage of preterm births; percentage of stillbirths; and percentage of small-for-gestational age (SGA) births.

* Hypothesis 1: Group ANC will increase institutional birth rates by 5% over one year.
* Hypothesis 2: Group ANC will increase completion of 4 ANC visits by 5% over one year.
* Hypothesis 3: Group ANC will reduce infant mortality rate by 5% over one year.
* Hypothesis 4: Group ANC will reduce the postpartum contraceptive prevalence rate by 5% over one year.
* Hypothesis 5: Group ANC will reduce the stillbirth rate by 5% over one year.
* Hypothesis 6: Group ANC will reduce the perinatal mortality rate 5% over one year.
* Hypothesis 7: Group ANC will reduce the combined infant mortality and stillbirth rate by 5% over one year.

Objective 2: Assess the mechanisms of implementation of group antenatal care through quantitative participant survey measures, qualitative focus group discussions and key informant interviews.

* Hypothesis 1: Group antenatal care will be acceptable to participants and providers, and preferred to individual care.
* Hypothesis 2: Group antenatal care will increase pregnant patients' access to and utilization of delivery services through improved knowledge, self-efficacy, social support and birth planning.

Objective 3: Report on key aspects of the implementation process: costs, human resources, logistics, and fidelity of the group antenatal program to model content and participatory processes.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 15-49 years old
* Resident of 14 village clusters in study site
* Intervention cohort: less than 24 weeks' gestation prior to first group antenatal care session.

Exclusion Criteria:

* Intervention cohort: more than 24 weeks' gestation prior to first group antenatal care session.
Study of Pelvic Hypofractionated Radiotherapy in Endometrial Cancer

This study will investigate if a shorter treatment course (known as "hypofractionation") for pelvic radiation is safe for women with endometrial cancer. Doctors leading the study will also determine the safest and most tolerable dose of shortened radiation (hypofractionation) used to treat women in this study. Because this study will shorten the radiation course typically used to treat endometrial cancer, each daily treatment given to women in this study will be slightly higher than normal to ensure that the total radiation dose they receive is still effective and similar to the radiation dose they would receive if they were not participating in this study (standard treatment).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary cervical cancer or uterine cancer of any histology
* Age ≥ 18 years.
* Non-metastatic disease according to the International Federation of Gynecology and Obstetrics (FIGO).
* Must have been treated with definitive intent, including standard-of-care hysterectomy, without any gross residual disease post-operatively. Nodal dissection is not required, but if it is not performed, then diagnostic imaging to confirm absence of gross pelvic or para-aortic disease should be obtained pre- or post-operatively.
* Recommended to undergo whole pelvic radiotherapy without concurrent chemotherapy or para-aortic radiation. Chemotherapy before or after radiotherapy is acceptable.
* Eastern Cooperative Oncology Group (ECOG) PS≤ 2
* Able to provide informed consent and willingness to sign an approved consent form

Exclusion Criteria:

* Distant metastases as determined clinically or radiographically based upon standard-of-care work-up for endometrial cancer.
* Concurrent (or other) chemotherapy occurring at the time of study.
* Gross residual disease (cancer cells that remain after attempts to remove the cancer have been made) post-operatively and/or at the time of radiation based upon pre-op or post-op imaging, intra-operative findings, and gynecologic oncologists' judgment.
* History of small bowel obstruction, inflammatory bowel disease, irritable bowel syndrome, connective tissue disorder requiring ongoing active medical management, or prior radiation therapy directed to the pelvis.
* Unresolved grade 2 or higher chemotherapy-associated diarrhea or abdominopelvic pain requiring medication prior to the initiation of radiation.
* Recommendation to undergo para-aortic nodal irradiation.
High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis

The investigators hypothesise that high dose RIF (RIF35) will increase pericardial fluid RIF exposure and so enhance mycobacterial clearance, compared to standard of care dosing (RIF10).

This Phase 2b randomized, placebo-controlled, double-blinded trial will evaluate the efficacy and safety of RIF 35mg/kg compared 10mg/kg, added to standard first-line ATT, for the treatment of PCTB.

IMPI-3 - A Randomized Controlled Trial of High vs. Standard Dose Rifampicin for Effusive Tuberculous Pericarditis

Phase 2b Randomized, placebo-controlled, double-blinded clinical trial

The trial will enroll 100 adult participants with pericardial TB from two research sites in South Africa, with no exclusions being made on the basis of sex/gender, racial or ethnic group.

Consenting participants will be stratified by HIV status and PCF GX-Ultra status, then randomized 1:1 to receive either standard of care anti-tuberculosis treatment (ATT) or standard of care plus high dose Rifampicin (RIF), both administered orally for 2 months, followed by a continuation phase of 4 months' RH at standard doses.

Eligibility Criteria:
Inclusion Criteria:

1. Aged \>18 years
2. Suspected PCTB with confirmed pericardial effusion on echocardiography (i.e., echo free space of ≥1 cm anterior to the right ventricle in diastole)
3. Consent to study participation including testing for HIV-1 (if HIV status is unknown)
4. Microbiologically detected Mtb in PCF or diagnosis of probable PCTB. Probable PCTB (in the absence of a positive pericardial fluid culture) will be defined as per Mayosi et al.4:

   1. Evidence of pericarditis with microbiologic confirmation of Mtb- infection elsewhere in the body and/or
   2. Exudative, lymphocyte predominant effusion with elevated adenosine deaminase (≥35 U/L)
5. Participant will undergo pericardiocentesis (as per clinical indication)
6. Within 5 days of ATT initiation

Exclusion Criteria:

1. Glomerular filtration rate \<30ml/min or renal failure requiring dialysis
2. Rifampin-resistant TB
3. Severe concurrent opportunistic infection
4. Contraindication to placement of intra-pericardial catheter
5. Failed pericardiocentesis procedure and/or failure of placement of intra-pericardial catheter
6. Any disease or condition in which the use of the standard anti-TB drugs (or any of their components) are contraindicated. This includes, but is not limited to, allergy to any TB drug or their components.
7. In females: a positive urine pregnancy test result
8. Confirmed autoimmune disorders (e.g. systemic lupus erythematosus)

Additional Exclusions for Gadolinium contrasted CMR

1. Any implanted devices that are not MR compatible (e.g. pacemaker, defibrillators, cerebral aneurysm clips, cochlear implants etc.)
2. Claustrophobia
3. Gadolinium allergy
4. Inability to lie on a flat surface for prolonged periods of time (e.g. severe congestive cardiac failure)
5. Breastfeeding
Phase I/II, Open-Label Trial of Three Monoclonal Antibodies

Monoclonal antibody infusions will prevent rebound of viremia in well-suppressed HAART-treated individuals who began therapy during acute and early HIV-1 infection.


Eligibility Criteria:
Inclusion Criteria: HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. Acute or early HIV-1 infection at the time of HAART initiation defined by HIV-1 RNA detectable with a negative serology or a negative detuned ELISA. HAART for at least 15 months and no more than 1 detectable HIV-1 RNA value (above the 50 copy/mL) for at least 6 months prior to screening.

Laboratory values

* Absolute neutrophil count (ANC) equal to or greter than 750/mm3.
* Hemoglobin equal to or greater than 9.5 g/dL.
* Platelet count equal to or greater than 50,000/mm3.
* Calculated creatinine clearance (CrCl) equal to or greater than 80 mL/min according to the Cockcroft-Gault formula:

Men: (140-age in years) x (wt in kg) = CrCl (mL/min) 72 x (serum creatinine in mg/dL)

Female: (140-age in years) x (wt in kg) x 0.85 = CrCl (mL/min) 72 x (serum creatinine in mg/dL)

* AST (SGOT), ALT (SGPT), and alkaline phosphatase equal to or less than 5 x ULN.
* Total bilirubin equal to or less than 2.5 x ULN.
* Serum Lipase equal to or less than 1.5 x ULN

Negative serum pregnancy test within 14 days. All females of childbearing potential must agree to practice active birth control measures (barrier methods such as condoms, diaphragms, cervical cap, etc. or an intrauterine device such as a coil) to avoid pregnancy while receiving the study drugs and for 30 days after the last dose of the study drugs. Additionally, men enrolled in the study should practice active birth control for the same period of time with their female partners of childbearing potential.

Men and women age \>18 years. Ability and willingness of subject to give written informed consent -

Exclusion Criteria:

More than 1 detectable HIV-1 RNA value (\>50 copies/mL) within 6 months of screening visit

Pregnancy and breast-feeding.

Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.

Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 30 days prior to study entry.

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Effect of Using Adaptive Seating Equipment on Hand Function

Objective: The purpose of this study was to evaluate the effect of adaptive swiss ball seating as an alternative for standard chair seating on hand function in children with hemiparesis. Subjects: A total of 30 spastic hemiparetic cerebral palsied children (19 boys and 11 girls), aged 3-6 years participated in this study. They were randomly assigned into control and study groups of equal numbers each consisted of fifteen children (n=15). Methods: Peabody Developmental Motor Scales 2 (PDMS-2) was used to evaluate each child individually before and after three successive months of treatment (3 sessions per week), to assess 2 subtests (the grasping skills and visual motor integration skills) for all children of both groups. Control group who received a specially selected physical therapy program for hand function on a standard chair seating. Study group who received the same selected program for hand function on adaptive swiss ball seating.

The aim of this study was to evaluate the effect of adaptive swiss ball seating as an alternative for standard chair seating on hand function in children with hemiparesis.

In this study, a total of 30 spastic hemiparetic cerebral palsied children (19 boys and 11 girls) aged 3-6 years, they were selected from general hospitals and private centers in kafr El-Sheikh government, randomly assigned to either the control group (n=15), who received a specially selected physical therapy program for hand function on standard chair seating, or the study group (n=15), who received the same selected program for hand function but on adaptive Swiss ball seating. Both groups received 3 sessions per week for 3 successive months. Peabody Developmental Motor Scales 2 (PDMS-2) was used to evaluate each child individually before and after three successive months of treatment, to assess 2 subtests (grasping skills and visual motor integration skills).

Eligibility Criteria:
Inclusion Criteria:

* Children with hemiparetic cerebral palsy.
* The age of the selected children ranged from 3 to 6 years old.
* Degree of spasticity ranged from 1 to 1+, according to Modified Ashworth' Scale (Bohannon and Smith, 1987)
* They were able to follow instructions and understand commands included in both assessment and training procedures.
* They were able to sit independent with trunk control.

Exclusion Criteria:

* Children exposed to orthopedic surgeries or potolinium toxins injection in the last 6 mounth before intervention.
* Children with fixed upper limb deformities
* Children with hearing or visual impairments.
Safety, Pharmacokinetics and Pharmacodynamics of BEZ235 Plus MEK162 in Selected Advanced Solid Tumor Patients

This is an open label, dose finding, phase Ib clinical trial to determine the maximum tolerated dose (MTD) and/or RP2D of the orally administered PI3K/mTOR inhibitor BEZ235 in combination with the MEK1/2 inhibitor MEK162. This combination will be explored in patients with EGFR mutant NSCLC which has progressed on EGFR inhibitors and triple negative breast cancer, as well as pancreatic cancer, colorectal cancer, malignant melanoma, NSCLC, and other advanced solid tumors with KRAS, NRAS, and/or BRAF mutations. Dose escalation will be guided by a Bayesian logistic regression model with overdose control. At MTD or RP2D, two expansion arms will be opened in order to further assess safety and preliminary anti-tumor activity of the combination of BEZ235 and MEK162.

Study drugs will be administered orally on a continuous schedule, MEK162 bid and BEZ235 qd, a treatment cycle is defined as 28 days.


Eligibility Criteria:
Inclusion Criteria:

* histologically/cytologically confirmed, advanced non resectable solid tumors
* Measurable or non-measurable, but evaluable disease as determined by RECIST 1.0

Exclusion Criteria:

* Patients with primary CNS tumor or CNS tumor involvement
* Diabetes mellitus - Unacceptable ocular/retinal conditions

Other protocol-defined inclusion/exclusion criteria may apply
Good Shepherd: Back to Reality Series

The purpose of this pilot study is to explore whether the Back to Reality series of video games - Harry's Journey, Harry's Journal, and Pathways to care map - increase knowledge of the emotional, social, and psychiatric sequelae of problematic underage marijuana use among homeless and street involved youth. Additional objectives were to explore whether the video games promote awareness of the risk of psychosis associated with regular marijuana use among vulnerable youth.

This project pilots the use of educational video games designed to help youth gain awareness of the risk of mental health issues associated with regular marijuana use. By playing the Back to Reality video games, youths may absorb knowledge about where and how to access community care for symptoms associated with psychosis and problematic cannabis use. The purpose of this study is to pilot test the use of the Back to Reality series at increasing awareness of the social and emotional implications of underage substance use.

This study explores the effects of the Back to Reality video games compared to control video games (no content about mental health and addiction). Street involved and homeless youth registered with Good Shepherd services between the ages of 16 and 19 years of age will be recruited. The results will be assessed using quantitative questionnaires and qualitative interviews. The data will be statistically analyzed for significant differences in knowledge about the risk of psychosis linked to marijuana use among vulnerable youth. The qualitative interview assesses the participants understanding and views of potential emotional, social, and psychiatric sequelae associated with excessive marijuana use during.

Eligibility Criteria:
Inclusion Criteria:

* Homeless or street involved youth
* Registered at any of the Good Shepherd Hamilton Youth programs
* Male, female, or transgender youth from 16-19 years of age as of visit 1.
* Outpatient status
* Each youth must understand the nature this study and sign informed consent

Exclusion Criteria:

* Youth judged by Good Shepherd staff to be at serious suicidal risk.
* Youth who are being discharged from Good Shepherd programming.
* Youth who are currently admitted in an in-patient unit at a hospital.
* Youth who scores 5 or more on the Video Game Playing Problems questionnaire (Teijeiro Salguero \& Bersabé-Morán, 2002).
* Youth who do not have the capacity to provide informed consent.
Therapeutic Drug Monitoring of Tacrolimus Biliary Concentrations for Liver-transplanted Patients (STABILE)

The purpose of this study is to demonstrate that the biliary concentration of TCR is a good marker of its immunosuppressive activity.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years) of both sexes,
* Candidates for liver transplantation or retransplantation, whatever the etiology and severity of the underlying disease,
* Not having expressed their opposition to participation in the study

Exclusion Criteria:

* Bilio-enteric anastomosis,
* Associated transplantation of another organ
* Contraindications to TCR administration
* Delayed introduction of TCR (beyond the 5th postoperative day) whatever the cause.
Intradermal Suture Versus Stapling for Groin Skin Closure in Vascular Surgery (VASC-INF Trial)

Surgical site infection (SSI) is one of the most frequent and fearsome complications in vascular surgery due to its high morbidity and mortality. In addition, SSI is one of the factors related to the development of prosthetic infection. Consequently, it represents a significant increase in hospital stay and healthcare costs.

A 2021 meta-analysis on groin SSI prevention strategies in arterial surgeries reported that using intradermal sutures could be associated with a lower SSI rate. The published results from a single-center retrospective study comparing SSI rates before and after implementing an SSI prevention protocol also suggest better outcomes with intradermal suturing.

This study aims to assess the SSI incidences of both skin closure techniques in vascular surgery patients undergoing femoral artery approach through a perpendicular groin skin incision.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with chronic lower limb ischemia or aortic, iliac, or femoral aneurysm
* With a scheduled surgery for one of the following indications:
* Femoropopliteal Bypass
* Femorodistal Bypass
* Aortobifemoral Bypass
* Axillofemoral or Axillobifemoral Bypass
* Femorofemoral Bypass
* Femoral Endarterectomy
* Femoral approach for exclusion of an aortic aneurysm
* Surgical procedure with an incision perpendicular to the inguinal fold
* Patients who undergo both unilateral and bilateral surgical approaches \*

  \*Note: We will consider one patient as one intervention (i.e., bilateral approaches will be quantified as one single inguinal surgical approach). In the case of bilateral procedures, the same closure technique will be used for both sides.
* Patients who sign the written informed consent

Exclusion Criteria:

* Background of a previous surgical intervention in the groin area.
* Femoral approach carried out in a surgical emergency setting
* Femoral approach performed due to a femoral pseudoaneurysm
* A surgical procedure performed with a transverse/oblique incision to the groin
* A patient who withdraws consent for participating in the trial
Factors Associated To Intensive Care Admission And Mortality In Patients With Emphysematous Pyelonephritis

Emphysematous pyelonephritis is a lifethreatening necrotizing infection of the kidney characterized by accumulation of gas in the renal parenchyma and within the surrounding tissues. The aim of the study is to report the outcome of the management of this condition at the investigators institution and to determine the microbiological characteristics, antibiotic resistance patterns, and to analyze factors predicting mortality and intensive care unit admission.

The investigators are planning to perform a retrospective study analyzing cases of emphysematous pyelonephritis from a single tertiary care institution in the north of Mexico in the period of 2011-2021. The diagnosis of emphysematous pyelonephritis is confirmed by computed tomography. Demographic, clinical, biochemical, therapeutic management, and outcomes will be collected. Variables will be analyzed to determine factors associated with admission to intensive care unit and mortality. Urine cultures will be analyzed and drug resistance profile will be determined using microdilution plate. Clinical and demographic characteristics will be analyzed using Chi square test for categorical variables, and T-test for numerical variables. Statistical significance is set at p\<0.05. Statistical analysis will be performed with the SPSS software version 20.0.

Eligibility Criteria:
Inclusion Criteria:

* Emphysematous pyelonephritis confirmed with computed tomography
* Systemic inflammatory response
* Urinary tract infection symptoms
* Complete medical records
* Both genders included
* \>18 years old

Exclusion Criteria:

* Other infectious causes
* Asymptomatic bacteriuria
* Incomplete medical records
* Endourologic procedure 3 months before recruitment