cyrilzakka/clinical-trials huggingface dataset:
Nevirapine + 3TC Based Maintenance Therapy for HIV Infection

Type of study: Investigator initiated clinical study Study design: One arm, open label, pilot study (n=10) Research question Is treatment with Nevirapine + 3TC sufficient for HIV maintenance Risk Category B (no investigational drugs, non standard Tx) Therapies with 2 drugs are often done in HIV-maintenance. This is a systematical evaluation of such a two drug trial. Rescue therapy is well defined within the protocol. Centers (n) St. Gallen only Participants 10 HIV Patients already on nevirapine + 2 non-nuke RT-Inhibitors Study duration 24 weeks primary observation period after study termination, patients may opt to continue on the bi-therapy. Clinical follow up will then continue Sponsor/Investigator Pietro Vernazza, Kantonsspital St. Gallen Principal investigator Pietro Vernazza, MD. Kantonsspital St. Gallen Co-Investigators Patrick Schmid, MD, Matthias Hoffmann, MD

Financial source None (Pilot Study) If study demonstrates good results, an SNF grant proposal will be submitted

This is a pilot study to evaluate the efficacy of a two drug combination for Long term HIV maintenance therapy.

The study is conducted in order to confirm the feasibility of the combination of Nevirapine and lamivudine (3TC) in patients with long term fully suppressive therapy.

Patients (n=10) with a stable (\>6 months) Nevirapine based triple therapy and a full viral load suppression for at least 2 years will continue their therapy for 6 months with Nevirapine+3TC.

The primary endpoint is treatment failure defined as an HIV-RNA value \>100 cp/ml, confirmed by a second measurement.

Preliminary stopping rules are defined if results indicate futility. Futility is defined as a situation, where the investigators would stop their plan to conduct a multicenter comparative trial. Futility is reached, when the study documents more than 1 failure in the first 5 patients over 24 weeks of observation or more than 2 failures in all 10 patients.

Only 10 patients will be followed in this single center pilot study.

After an amendement (April 2017) the total number of 20 patients was increased to 20. Futility was defined as more than 2 failures in 20 patients.

Eligibility Criteria:
Inclusion Criteria:

* HIV-pos, 18 years
* Stable ART, Nevirapine based (plus 2 nukleotide-analogues), at least 6 months
* Viral load suppression at least 24 months Prior to inclusion (\<50cp/ml)

Exclusion Criteria:

* chronic Hepatitis B necessitating tenofovir therapy
The Health Effects of Small-sided Team Handball

The purpose of the project was to examine the fitness and health effects of participation in recreational Team Handball for untrained 20-30 year old healthy men and women.

Fitness and health effects of 12 weeks of recreational team handball in untrained adult men and women aged 20-30 years"

Adult men and women aged 20-30 years will be recruited to take part in a 12-week intervention with recreational team handball. Half of the participants are men (n=32), who are randomly assigned to a group playing recreational team handball (n=16) and an inactive control group (n=16). The women (n=40) are also divided and assigned to a group with regular participation in recreational team handball (n=20) and an inactive control group (n=20). The training sessions will be offered 2-3 times weekly for 70 minutes per session by a supervised trainer. The sessions involves an injury preventive warm-up and ball exercises for 15 minutes followed by recreational handball on small pitches such as 4 vs 4. A comprehensive testing protocol is conducted before and after the training period. The measurements includes body composition and bone mineralization, blood pressure, resting heart rate, fasting blood sugar, insulin, cholesterol and bone markers. In addition, a number of physical tests which involves fitness level (VO2max), intermittent work, muscle strength and balance will further be conducted. The testing takes place at the University of Copenhagen. The training sessions will also take place at the University of Copenhagen or in a handball club near the University. The study will be approved by the local ethical committee of Copenhagen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy women and men from 20-30 years old
* If women, a regular menstrual cycle length (25 to 32 days) with or without use of contraceptives.

Exclusion Criteria:

* Known familiar diseases
* If been smoking for the last two years before recruitment
* If involved in any regular physical training two years before recruitment
* Women: a peak oxygen uptake (VO2peak) higher than 45 mL/min/kg
* Men: a peak oxygen uptake (VO2peak) higher than 51 mL/min/kg
A Prospective Observational Registry of Peripheral Use of AngioJet Rheolytic Thrombectomy With Mid-Length Catheters

This registry collects observational data about how mid-length AngioJet catheters (ie XPEEDIOR and DVX models) are used in routine clinical practice.

The PEARL Registry collects real world data about mid-length AngioJet catheters to:

* Characterize usage patterns, treatment approaches, and targeted vessels
* Document treatment strategies, including specific techniques and concomitant therapies
* Collect outcome data during initial hospitalization and at a 3-month follow-up phone call or visit
* Evaluate the frequency of specific clinical events in relation to risk factors, diagnosis, and treatments provided
* Identify treatment strategies that may optimize procedural and clinical outcomes, to facilitate development of treatment guidelines
* Offer sites a valuable resource for tracking usage and performance of the AngioJet System at their institution

Information collected by the PEARL Registry is intended for educational and clinical research purposes only.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been treated with a mid-length AngioJet catheter(defined as 90-120 cm in length)
* Patient has provided appropriate authorization per institutional policy and procedure.

Exclusion Criteria:

* None
Study Evaluating the Effect of Lecozotan SR on the QTc Interval

This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled, 4-period crossover study.


Eligibility Criteria:
Inclusion Criteria:

* Women and men aged 18 to 55 years inclusive.
* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* History of any clinically important drug allergy.
* Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, and opiates).
Cinematherapy for Women With Depression and Anxiety

Group cinematherapy program in reducing depressive and anxiety symptoms in women diagnosed with Depressive Disorders and Anxiety Disorders.

Cinematherapy is a creative therapeutic intervention in which a trained professional prescribes the patient to watch a film and uses the characters and themes as metaphors to promote self-exploration and change. The effectiveness of cinematherapy as a therapeutic technique has been demonstrated through its effectiveness in improving participants' self-esteem, emotional expression and understanding, and interpersonal relationships, and in reducing depressive and anxious symptoms.The cinematherapy intervention involves a targeted selection of film content and activities designed to improve the patients' mental condition.The study includes eight meetings on a monthly basis (programming of eight films lasting approximately two hours and subsequent discussion on the contents of the film shown).

Eligibility Criteria:
Inclusion Criteria:

* female, aged 18-75 years;
* Diagnosis of Depressive Disorders (unipolar and bipolar) and Anxiety Disorders according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5), both new onset in subjects without a previous psychiatric history, and depressive and anxious recurrences;
* Taking psychopharmacological therapy;
* Fluent knowledge of the Italian language;
* Release of a written informed consent, signed by the patient or legal representative and partner.

Exclusion Criteria:

* Diagnosis of Schizophrenia or other psychotic spectrum disorders;
* Diagnosis of neurological disorders associated with cognitive decline;
* Current abuse of alcohol and psychotropic substances, with the exception of smoking;
* Refusal to sign the informed consent to participate in the study.
Rifaximin and Propranolol Combination Therapy Versus Propranolol Monotherapy in Cirrhotic Patients

To reduce portal pressure, the only recommended medication is nonselective beta blocker(NSBB). However, NSBB has some limitation to apply clinically because of poor response rate and compliance.

Recent literature has supported the role of bacterial translocation as a mediator of splanchnic vasodilatation and portal hypertension. This stimulates the release of pro-inflammatory cytokines and the activation of the vasodilator NO resulting in a more pronounced deterioration of the baseline hyperdynamic circulatory state. Selective gut decontamination with Rifaximin can induce inhibition of bacterial translocation and associated worsening of portal hypertension. The investigators hypothesized that Rifaximin plus NSBB could result in decrease of portal pressure in cirrhotic patients with esophageal varices.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis:diagnosed based on histology or unequivocal clinical, sonographic, and laboratory findings
* 19≤age≤75
* Hepatic venous pressure gradient \> 12 mmHg
* Informed consent

Exclusion Criteria:

* Shock status requiring vasopressor
* Active infection, for example Spontaneous bacterial peritonitis
* Acute renal failure patients of any cause
* Clinically relevant coronary artery disease(NYHA functional angina classification III/IV),congestive heart failure NYHA III/IV), clinically relevant cardiomyopathy, history of myocardial infarction in the past 12 months
* Poorly controlled hypertension (BP 150/100mmHg)
* Hepatocellular carcinoma
* History of another primary malignancy ≤ 3years
* Medical or psychological conditions that would not permit the subject to complete thte study or sign informed consent
* Pregnancy or lactation period
* Serum creatinine ≧ 6mg/dL
* Involvement in the conduct of other study within 30 days
* Known hypersensitivity to Rifaximin or propranolol
* Dysarrhythmia, inappropriate for study on investigator's judgment
Three-Dimensional Vascular Reconstruction of the Pancreas on Multidetector Computed Tomography Images and Its Impact on Patients Undergoing Pancreaticoduodenectomy

Three-Dimensional Vascular Reconstruction of the Pancreas on Multi detector Computed Tomography images and its impact on patients undergoing Pancreatoduodenectomy - A Prospective Observational Study IPDA is difficult to identify in pre op in routine CECT images IPDA is difficult to identify in intra op Identification of those major blood vessels (SMA, MCA, Left Renal vein) that lie around the IPDA and then to measure the distances between these major vessels and the IPDA, helps to determine the location of the IPDA

Pancreaticoduodenectomy (PD) is a complex surgical procedure performed for benign and malignant indications .

Vascular anatomy of the pancreatic head, is important in multiple aspects

* Classical arterial anatomy is observed in 55-79% of cases
* Arterial Variation is observed in around 25-30% of cases
* Relationship of the tumor to the blood vessels determines the resectability of tumor The presence of anatomical variations may increase the risk of complications through
* direct (bleeding due to intraoperative vessel injury)
* indirect (postoperative ischemia of tissues and anastomotic leakage) Preoperative understanding of the vascular anatomy of the pancreatic head is important in order to reduce intraoperative bleeding.
* IPDA is difficult to identify in pre op in routine CECT images. It is identified in only 20% of patients.
* IPDA is difficult to identify in intra op because- It generally originates from the posterior wall of superior mesenteric artery (SMA).The origin of IPDA frequently varies, which makes it difficult to identify in some patients. It is surrounded by dense lymphovascular tissue, which makes it difficult to identify IPDA during surgery.

IPDA can be identified in up to 86% of the time using 3D MDCT . Identification of those major blood vessels (SMA, MCA, Left Renal vein) that lie around the IPDA and then to measure the distances between these major vessels and the IPDA, helps to determine the location of the IPDA.

In the existing studies, they have not defined the impact of identifying IPDA on intra operative parameters ( Operative time, Blood loss) These studies have not used uniform landmarks in the identification of IPDA

Eligibility Criteria:
Inclusion Criteria:

• Consecutive Patients undergoing pancreaticoduodenectomy during the study period at ILBS

Exclusion Criteria:

* If surgery is not proceeded for any cause like Presence of metastasis, Unreconstructable portal or SMV involvement , SMA involvement of \>180 degree
* Refusal for consent
A Study Assessing the Safety, Tolerability, and Efficacy of Galegenimab (FHTR2163) in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (AMD)

This study will evaluate the safety, tolerability, and efficacy of intravitreal injections of galegenimab (FHTR2163) administered every 4 weeks (Q4W) or every 8 weeks (Q8W) for approximately 76 weeks in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) compared with sham control. After completing the study's last visit (Week 76), eligible participants will have the option to enroll in open-label extension study NCT04607148 (GR42558) and receive open-label galegenimab (FHTR2163) injections.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 60 years at time of signing Informed Consent Form;
* Visual acuity: best-corrected visual acuity (BCVA) letter score \>/= 24 letters (Snellen equivalent of 20/320 or better). If the study eye BCVA letter score is \>/= 69 letters (Snellen equivalent of 20/40 or better), the non-study eye must have a BCVA letter score of \>/= 44 letters (Snellen equivalent of 20/125 or better);
* Well-demarcated area of GA secondary to AMD with no evidence of prior or active choroidal neovascularization (CNV) in either eye.

Exclusion Criteria:

Ocular Exclusion Criteria, Study Eye:

* History of vitrectomy surgery, submacular surgery, or any surgical intervention for AMD;
* Previous laser photocoagulation or ITV anti-vascular endothelial growth factor (anti-VEGF) for CNV, diabetic macular edema, retinal vein occlusion, or proliferative diabetic retinopathy.

Ocular Exclusion Criteria, Both Eyes:

* GA in either eye due to causes other than AMD;
* Active uveitis and/or vitritis (grade trace or above) in either eye;
* Active, infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye;
* Retinal pigment epithelium (RPE) tear that involves the macula in either eye;
* Previous participation in interventional clinical trials for GA or dry AMD, except for vitamins and minerals, regardless of the route of administration (i.e., ocular or systemic) within the last 6 months.
Phase I/II, Open Label, Randomized, Safety and Immunogenicity Following DTwP-Hepatitis B-Hib-IPV Vaccine (Bio Farma) in Indonesian Infants

This trial is open label, comparative, randomized, phase I/II study, experimental, randomized, open-label, three arm parallel group study. The primary objective for phase I is to evaluate the safety of the DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine within 7 days after each dose. The primary objective for phase II is to evaluate protectivity of DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine.

This trial is open label, comparative, randomized, phase I/II study. For phase I, approximately 75 subjects will be recruited and will seamlessly continue to phase II recruiting 390 subject, in total 465 subjects.

In this study, DTwP-Hepatitis B-Hib-IPV (Bio Farma) vaccine will be compared to an active control (Registered DTwP-Hepatitis B-Hib Vaccine and Registered Inactivated Polio Vaccine). There are 2 formulas of DTwP-Hepatitis B-Hib-IPV Vaccine which will be used in the study. The regimen of the vaccine is 0,5 ml injected three-dose regimen with 28 days interval between doses. On the other hand, the control group will receive 0,5 ml of Registered DTwP-Hepatitis B-Hib vaccine and 0,5 ml Inactivated Bio Farma vaccine injected in three-dose regimen with 28 days interval between doses.

The safety and immunogenicity result of the Phase I study will determine the continuation of the next phase clinical trial. Clinical trial of phase II can be conducted after safety observation within 28 days after the third dose in phase I. Three hundred and ninety (390) healthy subjects aged 6-11 weeks of age will be recruited in Phase II trial.

Eligibility Criteria:
Inclusion Criteria:

1. Infant 6-11 weeks of age.
2. Infant born after 37-42 weeks of pregnancy.
3. Infant weighing more than 2.5 kg at birth.
4. Father or mother, or legally acceptable representative properly informed about the study and signed the informed consent form.
5. Parents will commit themselves to comply with the indications of the investigators and with the schedule of the trial.

Exclusion Criteria:

1. Child concomitantly enrolled or scheduled to be enrolled in another trial.
2. Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature ≥37.5°C on Day 0).
3. Known history of allergy to any component of the vaccines.
4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection.
5. Known history of congenital or acquired immunodeficiency (including HIV infection).
6. Child who has received in the previous 4 weeks of a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long term corticotherapy (\> 2 weeks).
7. Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis.
8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives.
9. Infant with a known history of diphtheria, tetanus, pertussis, Hib, hepatitis B infection.
BT-011 Pharmacokinetics of Botulism Antitoxin Heptavalent in Pediatric Patients

The purpose of this study is to verify the pediatric dosing recommendations for BAT product in pediatric patients that are treated with BAT product due to a confirmed or suspected case of botulism. A minimum of one serum sample should be collected but whenever feasible additional serum samples (up to three per enrolled participant) may be collected from the participant or obtained from surplus standard of care samples, if available, within 32 hours after BAT product administration. Safety of the BAT product will also be evaluated. Emergent will follow-up with the physician by telephone after 30 days post-BAT product administration to collect AEs, SAEs, and unanticipated events.

Primary Objective: To collect blood from pediatric participants to analyze the pharmacokinetics (PK) of BAT product to verify the current US FDA-approved pediatric dosing recommendations for BAT product.

Safety Objective: To evaluate the safety of BAT product in pediatric participants.

Protocol Design: This is a single arm, multi-site PK study in pediatric patients treated with BAT product.

Pharmacokinetic Parameters: The serum concentrations of BAT product obtained will be modeled using a population PK approach based on a previously developed model for BAT serotypes A through G in healthy adult human participants.

Safety Endpoints: The incidence of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI) that occur within 30 days after BAT product administration. In this study hypersensitivity/allergic reactions including serum sickness, febrile reactions, and hemodynamic instability and bradycardia, as well as reports of an infectious disease transmission will be included as AESI.

Eligibility Criteria:
Inclusion Criteria:

1. Legally authorized representative is able and willing to voluntarily provide informed consent and patients to provide assent, if applicable.
2. Pediatric participants (age groups: birth to \<two years, two to \<six years, and six to \<12 years).
3. Treatment with BAT product (initial dose only).
4. Blood sample can be collected (or standard of care sample scavenged) within 32 hours of completion of BAT product infusion.

Exclusion Criteria:

1. If the 5 mL blood sample volume is deemed, at the discretion of the investigator, to be unsafe based on patient weight or condition of health.
2. History of treatment with BabyBIG or other botulism antitoxin within the past 90 days.
Significance of Fluorescence Colposcopy With Autofluorescence Imaging for Cervical Cancer

Clinical Trial to access Significance of fluorescence colposcopy with autofluorescence imaging for the screening of cervical cancer

1. Perform pelvic vaginal exam of the subjective to know symptom, illness history, physical exam and basal state before fluorescence colposcopy.
2. Observe acetowhite epithelium and perform biopsy at suspicious lesion during fluorescence colposcopy.
3. Perform fluorescence colposcopy again after biopsy and confirm extraordinary reaction.
4. After 1\~2weeks follow up the subjective at opd and confirm biopsy result.

Eligibility Criteria:
Inclusion Criteria:

1. age : 20-65 years
2. abnormal cervical papanicolaou smear , no other specific cervical disease
3. subject to colposcopic biopsy or LEEP
4. signed voluntarily to informed concents with full knowledge after explanation abot objective, method, contents

Exclusion Criteria:

1. pregnant women
2. porphyria
3. severe cervical bleeding
4. genital chlamydia, gonorrhea infection
5. other drug user with possible interaction (e.g. photosensitizer)
6. no informed consent
Low Dose Decitabine + Modified BUCY Conditioning Regimen for High Risk Acute Myeloid Leukemia Undergoing Allo-HSCT

The purpose of this prospective, open-label, randomized multicenter study is to evaluate the safety and efficacy of low dose decitabine in combination with modified BUCY vs modified BUCY as a myeloablative conditioning regimen for high-risk patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (Allo-HSCT).

Allo-HSCT is the most effective treatment stratagey for high risk acute myeloid leukemia. At present, modified BUCY is the standard conditioning regimen for AML undergoing allo-HSCT in our institute. However, relapse occured in as high as 30-50% high risk AML patients after allo-HSCT. Thus, the best conditioning regimen for this subgroup remains to be optimized. Low dose decitabine in combination with chemotherapy have been shown to improve comple remission rate of high risk AML patients. To reduce the relapse rate after allo-HSCT, low dose decitabine is added in the modified BUCY regimen. In this study, the safety and efficacy of low dose decitabine + modified BUCY vs modified BUCY myeloablative conditioning regimens in high risk undergoing allo-HSCT are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age 12 to 60 years.
* Diagnosis of high-risk acute myeloid leukemia at the time of transplant. ("High-risk" AML features are defined by the following: relapsed or primary refractory AML; Secondary AML（AML Secondary to myelodysplastic syndrome(MDS) or treatment-related AML); extramedullary leukemia; adverse cytogenetic abnormalities of monosomy 5, monosomy 7, or deletion of 5q; or presence of FLT3 positive internal tandem duplication (FLT3/ITD+), particularly high allelic ratio.)
* Patient must have adequate pre-transplant organ function.

Exclusion Criteria:

* Age \<12 or \>60 years.
* Uncontrolled bacterial, viral, fungal, or other infection before conditioning regimen.
* Any other severe concurrent diseases, or have a history of serious organ dysfunction.
* Pregnant or lactating females.