cyrilzakka/clinical-trials huggingface dataset:
Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors

Part A: The purpose of this study is to find the maximum tolerated dose of BMS-777607 in subjects with advanced or metastatic solid tumors

Part B: The purpose of this study is to describe the preliminary activity of BMS-77607 in subjects with advanced or metastatic gastroesophageal cancer, hormone refractory prostate cancer, head and neck squamous cell carcinoma, and type I papillary renal cell carcinoma


Eligibility Criteria:
Inclusion Criteria:

Part A:

* Subjects with advanced or metastatic solid tumors who have either progressed on standard therapy or for whom standard therapy is not known

Part B:

* Subjects with advanced or metastatic gastroesophageal cancer, HRPrC, HNSCC, or PRCC who have either progressed on standard therapy, or for whom standard therapy is not known. Eighteen (18) subjects each with gastroesophageal cancer, HRPrC, and HNSCC will be treated. Subjects with PRCC (up to 18) will be enrolled as feasible
* Tumor paraffin tissue block or 6-10 unstained slides from the tumor tissue block must be provided
* Subjects with HRPrC must have either measurable disease or rising PSA levels (≥3 consecutive rising levels with at least 1 week interval and with PSA level ≥5 mg/ml). All other subjects must have measurable disease as assessed by CT or MRI

Exclusion Criteria:

* Know brain metastases
* Uncontrolled or significant cardiovascular disease
* Retinal atrophy
Study of BEZ235 as Monotherapy in Patients With Transitional Cell Carcinoma After Failure of Platinum Based Chemotherapy

The mTOR (mammalian Target of Rapamycin) protein is the center of the mTOR pathway that plays an important role in cell growth, proliferation, survival and angiogenesis through sensing and integrating energetic signals from cellular environment. The mTOR protein is composed of two complex, mTOR complex 1 (mTOR C1) and mTOR complex 2 (mTOR C2).

In regards of mTOR pathway dysregulations observed in TCC development, there is a rational to test BEZ23 in advanced TCC. BEZ235 is a pan-class I PI3K inhibitor that, in addition, binds to the catalytic site of mTOR, inhibiting mTOR C1 and mTOR C2.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically- or cytologically-confirmed locally advanced or metastatic TCC not amenable to curative surgery or radiation.
2. Documented disease progression (according RECIST 1.1 criteria) after first line platinum-based therapy (given in neoadjuvant/adjuvant or palliative setting).
3. An interval of \>4 weeks since last anticancer treatment.
4. Archival paraffin-embedded tumor tissue (block or at least 20 unstained slides) of the primary tumor and/or metastases. The most recent archival tissue is mandatory. Recidive of the disease should lead to perform if possible novel biopsies, as major oncogenic differences are found between primary tumor and secondary lesions.
5. At least one measurable lesion by MRI or CT-scan
6. ECOG performance status 0-1, in stable medical condition
7. Patients must have adequate organ function: Hemoglobin ≥ 9 g/100 ml, neutrophils ≥ 1,000/mm3, platelets ≥ 100,000/mm, INR ≤ 1.5, total serum bilirubin ≤ 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN (or \<5.0 x ULN if hepatic metastases are present), creatinine £1.5 x ULN, fasting plasma glucose \<140mg/dl, HbA1c \< 8%.
8. Patients must be over 18 years old and able to give written informed consent.
9. Signed informed consent prior to beginning protocol specific procedure

Exclusion Criteria:

1. Non- TCC bladder cancer
2. More than 2 prior chemotherapy regimens given for palliation.
3. Concurrent malignancy or previous malignancy in the last 3 years prior to start the study treatment (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer)
4. Patient with active uncontrolled or symptomatic central nervous system (CNS metastases).
5. Significant active cardiac disease including uncontrolled high blood pressure, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac arrhythmias.
6. Other uncontrolled medical condition (active infections requiring antibiotics, bleeding disorders, uncontrolled diabetes ...)
7. Other concomitant anticancer therapy.
8. Previous therapy with PI3K and/or mTOR inhibitors (sirolimus, temsirolimus, everolimus)
9. Concomitant drugs such as coumarin and warfarin, and drugs known to induce torsade de pointe, drugs known to be moderate or strong inhibitors or inducers of CYP3A4
10. Pregnancy or risk of pregnancy.
Strategies for Preventing Falls in the Elderly

Fall incidents are the third cause of chronic disability in the elderly, according to the World Health Organization (WHO). Recent reviews demonstrate that multifactorial and multicomponent intervention programs are effective in preventing falls in community-dwelling older adults. However, the application of these programs may not be accessible to a large part of the elderly population. The lack of continuity in the treatment of the consequences of falls, as well as the dissemination of prevention measures for this patient profile, could be minimized through the use of information and communication technologies. Method: This will be a randomized clinical trial that aims to evaluate the effects of two fall prevention strategies via telerehabilitation for elderly fallers after admission to an emergency room. It will be carried out by a multidisciplinary team with interventions for eight weeks and monitoring of outcomes over a period of four months. Patients will be evaluated regarding aspects of functionality in the second and month after the interventions and regarding the recurrence of falls during the four-month period. Discussion: The hypothesis is that the programs are viable in terms of accessibility to home training. However, to date, there is no evidence about the differences between these forms of interventions to prevent falls via telecare.

To compare the effects of two different strategies for preventing falls through telerehabilitation for elderly fallers after admission to an emergency room.

Eligibility Criteria:
Inclusion Criteria:

* elderly fallers

Exclusion Criteria:

* neurological diseases
P3 Study of Umbilical Cord Blood Cells Expanded With MPCs for Transplantation in Patients With Hematologic Malignancies

The study investigates the time to engraftment of a mesenchymal expanded cord blood unit in patients with hematologic malignancies undergoing transplantation with myeloablative conditioning.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have one of the following:

  * Acute myelogenous leukemia (AML) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
  * Acute lymphoblastic leukemia (ALL) in complete morphological remission at study screening (Complete Remission with Incomplete Platelet Recovery (CRp) acceptable).
  * Non-Hodgkin's lymphoma (NHL): High risk subjects with responsive disease after first relapse. High risk includes those with Burkitt's Lymphoma and those with extensive marrow involvement at diagnosis-precluding autologous transplant.
  * Hodgkin's disease: High risk subjects with responsive disease after first relapse.
* Minimum Karnofsky Scale
* Subject must weigh at least 20 kg
* Up to 65 years of age
* Adequate major organ system function

Exclusion Criteria:

* Pregnancy and/or lactating
* Suitable, 6/6 HLA matched related sibling donor available
* Previous participation in a stem cell study within last 30 days
Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages

Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.

The objective of this study is to evaluate and optimize a method of detecting sleep and sleep stages based on a new algorithm combining actigraphy and heart rate variability (measured by optical analysis of the pulse wave) to determine sleep architecture (segmented into three phases: WAKE, REM and NREM) with high accuracy compared to the gold standard polysomnography.

Eligibility Criteria:
Patients with sleep wake disorders

Inclusion Criteria:

* 18 ≤ Age ≤ 80 years
* Suspected sleep wake disorder (sleep apnea, sleep movement disorders, hypersomnia, parasomnia)
* Written informed consent

Exclusion Criteria:

* Skin condition with eczema or damaged skin
* Ischemia (cutaneous)
* Allergy against nickel
* Allergy against silicone
* Current treatment with vasoactive drugs (e.g. beta-blockers, calcium channel antagonists, nitroglycerin, etc.) and/or antidepressive drugs (e.g. serotonin reuptake inhibitors, etc.).
* Known infection with multiresistant bacteria
* Implanted devices (e.g. pacemaker, pumps)
* Rhythmogenic heart disease (e.g. resting heart rate \> 120/min)
* Severe or untreated arterial hypertension (blood pressure \> 140mmHg systolic, \>90mmHg diastolic)
* Hypotension (blood pressure \< 90mmHg systolic, \< 60 mmHg diastolic)
* Current alcohol or drug abuse, alcohol consumption the same day as the study
* Consumption of coffee 7h before
* Dark skin pigmentation
* Severe metabolic disease (e.g. diabetes)
* Pregnancy or lactation
* Physical handicap effecting the two arms
* Wound in the wrist region
* Too large or too small wrist

Healthy subjects

Inclusion criteria:

* 18 ≤ Age ≤ 80 years
* Written informed consent

Exclusion criteria:

* Skin condition with eczema or damaged skin
* Ischemia (cutaneous)
* Allergy against nickel
* Allergy against silicone
* Any Medication (except birth control pill)
* Known infection with multiresistant bacteria
* Implanted devices (e.g. pacemaker, pumps)
* Rhythmogenic heart disease (e.g. resting heart rate \> 120/min)
* Severe or untreated arterial hypertension (blood pressure \> 140mmHg systolic, \>90mmHg diastolic)
* Hypotension (blood pressure \< 90mmHg systolic, \< 60 mmHg diastolic)
* Current alcohol or drug abuse, alcohol consumption the same day as the study
* Consumption of coffee 7h before
* Implanted devices (e.g. pacemaker, pumps)
* Known sleep-wake disorders
* Dark skin pigmentation
* Severe metabolic disease (e.g. diabetes)
* Pregnancy or lactation
* Physical handicap effecting the two arms
* Wound in the wrist region
* Too large or too small wrist
48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)

Double-blind, randomized, placebo-controlled, single- center study followed by an open-label extension period.

• The study will have two parts:

* Part 1: 24 weeks double-blind treatment (DB), followed by
* Part 2: 24 weeks open-label extension (OLE) - all subjects still participating at the end of Part 1 will be given an option to continue for additional 24 weeks on the active drug if evaluated eligible by the Investigator

Part 1 - the double-blind (DB) part: The active medication arm will be given co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks. The placebo arm will receive matching placebo tablets.

Part 2 - the open-label extension (OLE) part: All active participants at the end of the double-blind part will be given the active medication 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities
* Males and females, aged 18-75
* Confirmed diagnosis of HIO
* BMI ≥27 kg/m2 (where overweight is related to the HIO)

Exclusion Criteria:

* Blood Pressure (BP) ≥160/90 mmHg
* Heart rate (HR) ≥ 90, \<50 bpm
* Type 1 diabetes, Cushings disease, acromegaly, hypophysitis, infiltrative diseases or Prader-Willi syndrome
* Heart failure New York Heart Association (NYHA) level II or greater, decompensated heart failure
* Previous myocardial infarction or stroke within the last 5 years
Pregnancy Outcomes After Uterine Cavity Expansion

This study seeks to evaluate pregnancy outcomes following hysteroscopic uterine cavity expansion surgery for patients with dysmorphic uterine cavities and poor reproductive histories. Patients already planning to undergo surgery at the recommendation of their physicians will be recruited for participation.

Any patient scheduled to undergo hysteroscopic expansion of the uterine cavity at RMANJ is eligible to participate in the study. Patients will be approached for consent to participate in the study prior to undergoing surgery. If enrolled, outcomes following surgery will be followed and recorded.

Eligibility Criteria:
Inclusion Criteria:

* Any patient scheduled to undergo hysteroscopic expansion of the uterine cavity

Exclusion Criteria:

* None
Changes in Selected Function- and Participation-related Characteristics in Post-COVID Patients Following Pneumological Phase II Rehabilitation

The aim of this project is to provide insight into the relatively new group of post-COVID patients. On the basis of data collected in routine practice, function- and participation-related patient characteristics of post-COVID patients are first described descriptively. Subsequently, the extent to which selected function- and participation-related parameters change following a pneumological phase II rehabilitation in this group of patients is investigated. Furthermore, the extent of these possible changes will be compared between post-COVID patients who received respiratory muscle training and post-COVID patients who did not receive respiratory muscle training. Patients were not randomized but assigned to conditions based on medical criteria (e.g., initial respiratory muscle strength).

The present project provides insight into participation- and function-related characteristics of a relatively new patient population, enables the observation of changes in these following pneumological phase II rehabilitation and provides differentiated insights into the course of health-related parameters for specific subgroups (respiratory muscle training vs. no respiratory muscle training).


Eligibility Criteria:
Inclusion Criteria:

The study participants were regular patients in a rehabilitation centre. The data basis consists of secondary data collected during routine operation.

Exclusion Criteria:

-
Reliability and Validity of the Finnish Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale

There are no validated patient-reported outcome measures to assess lower extremity function in Finnish language. The present study aimed to 1)translate and culturally validate the Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale, and 2) study the psychometric properties of these two questionnaires

This study assesses the reliability and validity of the Finnish versions of the Visual Analogue Scale Foot and Ankle and the Lower Extremity Functional Scale. The English versions were translated and trans-culturally adapted into Finnish language according to well accepted international translation guidelines. The psychometric properties are assessed by internal validity, intraclass correlation coefficient and test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* Pathology of the foot and ankle and
* Surgery due to foot and ankle problems

Exclusion Criteria:

* Other than foot and ankle surgery
* age under 18 years
National Varicose Vein Study - Portugal

The National Varicose Vein Study is a cross-sectional, multicenter, observational study. The primary goal is to evaluate the 30 days outcome of the conventional great saphenous vein surgery (stripping) in the treatment of the symptomatic chronic venous insufficiency, comparing the results of difference Portuguese's health centers, comparing the following variables: thrombo-prophylaxis (pharmacology or mechanic; compliance); antimicrobial prophylaxis; quality of life; medication compliance; complications and work incapacity period.

Chronic venous disease is one of the most prevalent pathologies in the world population. It presents a spectrum of variable manifestations, culminating in the most severe form, active venous ulcer. The clinical evaluation, the study of venous anatomy by echo- Doppler and the indications for surgical treatment are standardized in guidelines. The same applies to the techniques for surgical treatment that, in the long term, present equally satisfactory results. Thus, currently, in the Portuguese national health system, the surgical technique most frequently used is conventional surgery. As for postoperative care, namely thromboprophylaxis regimens, analgesia regimens, there is greater variability in its application between clinics and institutions, which may result in significant differences in postoperative recovery. In this way, we intend to develop an observational, cross-sectional and multicenter study, comparing postoperative care protocols and patient compliance and impact on quality of life, as well as absence from work.

The primary goal is to evaluate the 30 days outcome of the conventional great saphenous vein surgery (stripping) in the treatment of the symptomatic chronic venous insufficiency, comparing the results of difference Portuguese's health centers, comparing the following variables: thrombo-prophylaxis (pharmacology or mechanic; compliance); antimicrobial prophylaxis; quality of life; medication compliance; complications and work incapacity period.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated at CHUP, CHUSJ and CHUC
* Male and female;
* Age over 18 years;
* All clinical presentations (C) included in the CEAP classification system;
* Period from November 2022 onwards;
* Conventional surgical treatment of at least one great saphenous vein;
* Patients treated using the following techniques: arch ligation +/- trunk stripping.

Exclusion Criteria:

* Exclusive or concomitant treatment with endovenous surgery (thermal ablation by laser or radiofrequency...);
* Treatment by conservative conventional surgery of the great saphenous vein (CHIVA, ASVAL);
* Varicose surgery not involving the great saphenous vein;
* Age under 18 years;
* Patients treated in hospital units not covered by the study.
Cheetah - Sterile Glove and Clean Instrument Change at the Time of Wound Closure to Reduce Surgical Site Infection

To assess whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection

Internal Pilot

The aim of the 12-month internal pilot is to assess:

1. whether hospitals adhere to their allocation
2. what proportion of patients who are eligible for ChEETAh can be followed up successfully at 30 days after their surgery

Main Study

To assess whether the practice of using separate sterile gloves and instruments to close wounds at the end of surgery compared to current routine hospital practice can reduce surgical site infection at 30-days post-surgery for patients undergoing clean-contaminated, contaminated or dirty abdominal surgery

Eligibility Criteria:
Inclusion Criteria

* Countries: LMICs defined by the Development Assistance Committee (DAC) Official Development Assistance (ODA) list where there are at least 4 eligible hospitals per country in HIC-CHEETAH protocol (HICs are those that do not appear on the Organisation for Economic Co-operation and Development's Official Development Assistance (ODA) list
* Hospitals (clusters): in LMICs where glove and instrument change is not currently routine hospital practice
* Participants: Patients undergoing abdominal surgery who satisfy the following criteria are eligible:
* Emergency (surgery on an unplanned admission) or elective (surgery on a planned admission)
* Intraoperative finding of clean-contaminated, contaminated or dirty surgery
* with at least one abdominal incision that is ≥5cm
* Aged 16 years and over on the day of surgery (applicable to HIC-CHEETAH protocol only)

Participant Exclusion Criteria:

• Patients undergoing caesarean section
Valproate Sustained Release Minitablets (Orfiril(R) Long) Once Daily in the Evening

Valproate is the first line therapy in primary generalized seizures. The applied drug contains sodium valproate in sustained release minitablets. As a multiple unit dosage form these can be easily swallowed and taken independent from meals.

A simple dosage scheme like valproate sustained release minitablets once daily in the evening should improve the compliance and likely the seizure situation of the patients. The data of this non interventional trial were directly extracted from the physician's electronic patient database. The observational period was 7 weeks compared to a retrospective period 7 weeks before start of the study.


Eligibility Criteria:
Inclusion Criteria:

* age of 12 years and above
* epilepsy patients
* indication to initiation / conversion to valproate sustained release minitablets once daily

Exclusion Criteria:

* contraindication to valproate use
* no indication for conversion to valproate sustained release minitablets once daily
A Study to Evaluate the Safety and Efficacy of DSFNC1 Soft Hydrophilic Contact Lenses and SiHy Color Soft Hydrophilic Contact Lenses

This project is an open, parallel, randomly controlled, and non-inferiority clinical trial of DSFNC1 soft hydrophilic contact lenses with SiHy color soft hydrophilic contact lenses.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old, gender is not limited;
2. Soft hydrophilic contact lenses to be worn range from 0.00 to -12.00D;
3. Both eyes were normal with no other abnormality or disease other than refractive error;
4. Best-corrected eyesight ≥ 1.0 in both eyes with frame lenses;
5. Astigmatism ≤ 2.0D;
6. T5ar film break-up time (BUT) \&gt;5s in both eyes
7. Those who are able to complete a minimum of 90 days of follow-up and are able to wear contact lenses as required by the protocol;
8. Ability to understand the purpose of the trial, to participate voluntarily and to have Informed Consent signed by the subject himself/herself or his/her legal guardian.

Exclusion Criteria:

1. Persons with any systemic condition that contraindicates the wearing of contact lenses, or who are receiving treatment that interferes with vision or the wearing of contact lenses;
2. Those who had worn hard contact lenses within 4 weeks or soft contact lenses within 7 days prior to enrollment in this trial;
3. People who are allergic to contact lens, and people with systemic allergic diseases;
4. Patients with conical corneas or other irregular corneas;
5. Those who have to wear soft hydrophilic contact lenses for a long period of time under special circumstances such as dryness, severe dust or volatile chemicals;
6. Those who are pregnant, breastfeeding, or planning a pregnancy at the time of enrollment;
7. Those who were eligible for enrollment in only one eye;
8. Concurrent participation in other clinical trials or participation in a soft contact lens clinical trial of soft hydrophilic contact lenses within 10 days prior to enrollment in this trial
9. Participants who have participated in a clinical trial of a drug or a medical device other than a contact lens within 3 months prior to enrollment in this trial;
10. Other conditions that, in the judgment of the investigator, make wearing soft contact lenses unsuitable or preclude enrollment.