cyrilzakka/clinical-trials huggingface dataset:
Clinical and Functional Variables in Oncology

The aim is to analyse the effect of a Therapeutic Exercise and Education programme in several clinical and functional outcomes in cancer patient and survivors

In the oncology field, both patients and survivors have to face several symptoms, like cancer-related fatigue or pain. Cancer patients also have affected quality of life, lower levels of function and they are at higher risk of weight gain following diagnosis. Given the risk of obesity, both exercise and diet play a key role in recovery from cancer.

Hence, the aim of this study is to show the effect of a Therapeutic Exercise and Education programme (TEEP) in clinical and functional, including practical nutritional education in other clinical and functional secondary outcomes in cancer patients and survivors.

Variables included are: body composition, mediterranean-diet adherence, quality of life (QoL) and functional outcomes (limb functionality, physical activity, physical function and handgrip strength). Furthermore, laboratory variables like muscle thickness (ecography) and muscle activity (electromyography) were included.

Eligibility Criteria:
Inclusion Criteria:

* In the case of survivors: Patient who had been surgically treated for their primary tumour with no evidence of recurrence at the time of recruitment. The inclusion of patients undergoing hormonal treatment radiotherapy or antiHER therapy will be allowed.
* In the case of cancer patients: patient who had been dignosed by cancer.

In both cases, all participants have to maintain the minimum physical function to perform exercise in group.

Exclusion Criteria:

* Patients were excluded if they had suffered any cardiovascular event defined as stable or unstable angor, acute pulmonary edema, cardiac rhythm disorders, or syncope of cause not affiliated in the year prior to inclusion
Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders

SLeeP AID4 is a single-group, single-arm, Canada-wide, non-randomised, unblinded, in-home, observational study to prospectively collect and build a data set of natural sleep behaviour and physiology in maternal-fetal dyads (and bed partners, if applicable) in the third trimester of pregnancy in the home setting and subsequently investigate the feasibility of using computer vision technology (CVT) to monitor sleep during and across the third trimester of pregnancy in the home setting for research purposes by eliciting participants' attitudes toward CVT and training, validating, and testing a CVT model to accurately, unobtrusively, non-invasively, and objectively detect and quantify various sleep behaviours, disturbances, and disorders.


Eligibility Criteria:
Participant Inclusion Criteria:

* Healthy (see American Society of Anesthesiologists Physical Status \[ASA-PS\] classification; participant must be ASA-PS class II or lesser)
* Have a singleton pregnancy
* Be in the third trimester (gestational age between 28 weeks and 0 days through 40 weeks and 6 days, inclusive, by first-trimester ultrasound)
* Live in a home with a 2.4 GHz Wi-Fi network
* Sleep in a bed at night (i.e., not a La-Z-Boy chair or similar)

Participant's Bed Partner (if applicable) Inclusion Criteria:

* Sleep in the same bed as the pregnant study participant.
* Healthy (see American Society of Anesthesiologists Physical Status \[ASA-PS\] classification; participant must be ASA-PS class II or lesser)

Participant Exclusion Criteria:

* Non-English speaking, reading, or writing
* ASA-PS class III or greater

Participant's Bed Partner (if applicable) Exclusion Criteria:

* Non-English speaking, reading, or writing
* ASA-PS class III or greater
Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes

This trial is conducted in Africa, North and South America, Asia and Europe. The purpose of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus insulin glargine once-daily on glycaemic control after 30 weeks of treatment in insulin-naïve subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years or older at the time of signing informed consent
* Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
* HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period
* Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
* Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term treatment (7 days or less in total) with insulin in connection with intercurrent illness
* History of chronic or idiopathic acute pancreatitis
* Screening calcitonin value greater than or equal to 50 ng/L
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
* Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m\^2 per modification of diet in renal disease (MDRD) formula (4 variable version)
* Acute coronary or cerebrovascular event within 90 days before randomisation
* Heart failure, New York Heart Association Class IV
* Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
* Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
* Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Patupilone (EPO 906) in Patients With Recurrent or Progressive Glioblastoma

Patupilone trial for patients with recurrent glioblastoma, which are planned for re-operation. Objectives: prolongation of PFS compared to patients with re-operation only, Patupilone tumor concentrations, pharmacokinetic, Perfusion in MRI pre - and post Patupilone. Translational research of tumor tissue exposed to patupilone.

* Trial with medicinal product

Prior to and after re-operation patients with recurrent glioblastoma receive the investigational drug Patupilone, a tubulin-inhibitor.

The purpose of the trial is to prolong PFS in this patient population. Patupilone is already used in clinical trials of other tumor entities such as ovarian cancer, breast and lung cancer. Side effects are expected to be manageable.

Eligibility Criteria:
Inclusion criteria:

* Recurrent glioblastoma at least 2 cm in diameter after standard treatment (Surgery, Radiotherapy and Chemotherapy), which has to be completed at least three weeks earlier.
* \> 18 years of age, KPS 70-100%
* No liver disease, no malignancies (except curative treated skin tumors, DCIS of the breast and curative treated cervix carcinoma)
* Lc \> 3000 und Tc \> 100 000, Hb\> 9, Bilirubin \</= 1.5mg/dl, AST/ALT less than 2.5 x upper limit, creatinine \</= 132umol/l
* No pregnancy or breast feeding
* Written Informed Consent prior to study entry
* No reasons for incompliance
* Reoperation planned

Exclusion criteria:

* KPS \< 70%
* Radiotherapy- or Chemotherapy within 6 weeks
* Enzyme inducing medication or St John's wort
* Other study medication within 28 days
* Other malignancies
* Intolerance of Patupilone
* Prior Patupilone
* Neuropathy \> Grad 1
* Other life threatening illnesses
* Acute or chronic liver diseases
* HIV Infection
* Known non-compliance in medication intake,inability to give informed consent
* Cardiac problems (NYHA III oder IV) with uncontrolled insufficiency or angina pectoris
* Active or uncontrolled infection
* Pregnancy or breast feeding
* Hematologic Growth Factors (without Erythropoetin) colostomy
* Patients with uncontrolled diarrhea in the last 7 days prior to study entry.
Efficacy, Tolerability, and Cognitive Effects of Deep Transcranial Magnetic Stimulation for Bipolar Depression

The aim of this study is to evaluate the feasibility and efficacy of deep transcranial magnetic stimulation (dTMS) as an add-on treatment for bipolar depression. Meanwhile, we aim to evaluate the effect of dTMS on cognitive function of bipolar depressive patients. we hypothesize dTMS would improve depressive symptoms and cognitive function in bipolar disorder.

This is a randomized, double-blind, sham-controlled study to detect the effect of dTMS for treatment of bipolar depression. 100 participants were randomly assigned 1:1 to dTMS group or sham-control group. For both active and sham group, daily dTMS sessions were scheduled in a 5-day sequence for four consecutive weeks, and each session lasted 20minutes. Based on the original and stable medication, the active stimulation consisted of 55 18 Hz, 2 s trains at 120% MT intensity, with a between-train interval of 20 s (1980 pulses per day or 39 600 pulses per treatment). The sham stimulation was performed using the same procedures, with the sham coil.

Scale assessments are performed at baseline, week 2, week 4 and week 8. Collection of blood took place at baseline, week 4 and week 8.

Eligibility Criteria:
Inclusion Criteria:

Confirmed diagnosis of bipolar depression;

* Met standardized criteria for failure to achieve remission from pharmacological treatment in the current illness episode;
* Pharmacological treatment maintained unchanged for the four weeks preceding rTMS application；
* Able to read, verbalize understanding and voluntarily sign the informed consent form prior to performance of any study-specific procedures or assessments

Exclusion Criteria:

* Previous treatment with rTMS;
* Ferromagnetic material close to the head;
* Cardiac pacemaker and/or implanted electronic device;
* The presence of neurological disorders (uncontrolled epilepsy, previous significant head injuries, brain surgery);
* Pregnancy or lactation;
* Significant medical and/or psychiatric comorbidities;
* Substance abuse in the last three months (not including caffeine or nicotine);
* Acute psychosis;
* Acute suicidality;
* Patient refuses to sign consent for participation in the study
Peritoneal Dialysis Catheter Function

The straight Tenckhoff is the most common catheter for peritoneal dialysis. A new, more expensive,self-locating catheter with a heavy tip has been developed by Di Paolo. The investigators used these catheters in parallel for several years. To clarify what catheter has least problems the investigators performed a comparative study to clarify if outflow problems differed between these catheters.

The straight Tenckhoff catheter (sT) is the most common used catheter for peritoneal dialysis (PD). A new, more expensive, self-locating catheter (sLC) has been developed by Di Paolo. The investigators had used both in parallel for several years. To clarify what catheter to focus on in the future the investigators performed a comparative study to clarify if outflow problems differed between these catheters.

Study design: interventional and randomized at the same hospital Patients: Patients that were planned to start PD were informed and asked to participate in the randomized study. All patients who were asked accepted and consented to be included in the investigation.

At the investigators hospital, insertion of pertitnoean dialysis catheters is performed by open surgery. This is performed using a three layer suture technique performed in local anesthesia. The technique enables immediate start of dialysis after surgery.

Outflow problems were defined as a delay of flow of more than 40 minutes for 500ml of PD fluid.

The duration of time was calculated by months on PD. Patients who died, were transplanted or changed for hemodialysis were censored. End-point was an insufficient drainage/flow of dialysis fluid that unabled adequate dialysis and intervention (by surgery) was necessary to correct/change catheter.

Statistical analyses used were Breslow test and Kaplan Meier survival curve.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients that are eligible and planned to start peritoneal dialysis and thereafter accept to be part of the study.

Exclusion Criteria:

* None
Effect of Agar Administration on Defecation and Fecal Condition in Chronic Constipated Patients

The administration of agar jelly may increase the number of defecation and the volume of feces, and then may improve fecal condition in chronic constipated patients.

Each subject eats one cap of agar jelly shortly before having dinner every day for 4 weeks.

At 0, 7th, 14th, 21th, and 28th day , the frequency of defecation and defecation condition is assessed.

Eligibility Criteria:
Inclusion Criteria:

* subjects take laxatives.

Exclusion Criteria:

* subjects underwent abdominal surgery.
Effect of Reverse Nordic Exercise on Vertical Jump in Youth Soccer Players

BACKGROUNDː The reverse nordic hamstring exercise is developed for the eccentric work of the rectus femoris. After performing Nordic exercise protocol (its original), the relationship between increased eccentric hamstring strength, improvements in sprint capacity and reduced incidence of injuries can be confirmed. The review of evidence, led us propose the relationship and the possible benefits that could exist in the performance of four weeks of reverse nordic exercise protocol and the vertical jump, measured with countermovement jump test (CMJ) on a platform of jump.

METHODSː An open randomized controlled trial was conducted, with an intervention and control group, to which they were randomly assigned. The sample was made of 19 players from the San Antonio de Murcia Catholic University Team in the youth A category, aged between 16 and 18 years old. The experimental group (n=10) performed the reverse nordic hamstring exercise protocol for four weeks, in addition to the usual training that they shared with the control group (n=9). Data collection for the CMJ test was done before starting the protocol and immediately after finishing it for all participants. Statistical analysis was carried out with the SPSS program.


Eligibility Criteria:
Inclusion Criteria:

* Between 16 and 18 years old
* Soccer Players

Exclusion Criteria:

* Pathologies or Musculoskeletal Injuries in the last 6 months
* Surgical Interventions in the lower extremities in the last 6 months
Epirubicin and Docetaxel Combination (ET) or Epirubicin Followed by Docetaxel (E/T) for Node Negative (N0) High Risk Breast Cancer Patients

The combination of taxanes, and especially docetaxel, with an anthracycline seems to be an important part of the chemotherapy regimens used in the adjuvant setting of patients with early-stage node-positive breast cancer patients. Whether sequential or concurrent administration of these drugs is preferable is not yet known, especially in patients with node-negative high risk tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast adenocarcinoma.
* Within 20-45 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
* Absence of lymph node involvement after eclosion and hormone (E\&H) staining and light microscopy evaluation.
* Premenopausal or postmenopausal women with at least one of the following tumor characteristics is required in order to characterize the tumor as high risk:

  * Estrogen receptor (ER) (-) and progesterone receptor (PR)(-);
  * Ki-67 + \> 30%; Grade III; HER2 (3+) (after an amendment on 15.05.2008 women with HER2 (3+) were not included); Perineural infiltration or presence of tumor emboli in blood or lymph vessels.
* Postmenopausal women with tumors 1-2 cm are eligible if the tumor has at least 2 of the above mentioned high risk criteria.
* Premenopausal and postmenopausal women with tumors measuring \> 2 cm are eligible irrespectively of the expression of the above adverse prognostic tumor criteria.
* Absence of any clinical or radiological evidence of local or metastatic disease.
* Age \> 18 years.
* Performance status (WHO) \< 3.
* Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3).
* Adequate liver (bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2 mg/dl).
* Adequate cardiac function (LVEF \> 50%).
* Negative pregnancy test.
* Informed consent.

Exclusion Criteria:

* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
* Other concurrent uncontrolled illness that could affect compliance with the study.
* Psychiatric illness or social situation that would preclude study compliance.
* Pregnant or nursing women.
* History of allergic reaction attributed to docetaxel.
* Other concurrent investigational agents.
Hand Motor Rehabilitation Using a Wearable Robotic Device (WRL HX MCP)

The purpose of this pilot study is to assess the safety and usability of the WRL HX MCP medical device, a prototypal robotic system for metacarpophalangeal joint mobilization. WRL HX MCP was developed by the Wearable Robotics Laboratory of Scuola Superiore Sant'Anna in a project funded by and in collaboration with INAIL, to fulfil the needs of patients with post-traumatic hand stiffness.

This study aims to:

1. Test the safety and reliability of the WRL HX MCP device for assisting flexion and extension movement of the stiff metacarpophalangeal joint
2. Conduct a preliminary examination of the efficacy of the device in the treatment of joint stiffness to design a subsequent RCT
3. Evaluate the performance of the device in estimating the biomechanical parameters useful for the objective treatment outcome assessment.

Ten injured workers with post-traumatic and/or post-operative index finger MCP stiffness will be enrolled in a clinical trial consisting of one to four sessions of robotic therapy with WRL HX MCP at the INAIL Rehabilitation Center in Volterra.

Pilot testing of the experimental device will include the preliminary goniometric measure of passive and active MCP range of motion (ROM), the selection of the appropriate size of exoskeleton segments to fit user's anthropometry, the robotic assessment of ROM, force and torque trajectories of MCP joint, a program of robot-assisted passive and active MCF mobilization and a final clinical and robotic reassessment of joint ROM. The session will last about 1 hour and all exercises will be administered by a trained physical therapist supported by two members of the engineering team; pain level will be assessed at baseline and after each mobilization sequence; patient feedback will be recorded about the usability of the device in term of comfort, wearability, user safety, and overall satisfaction.

For Aim 1, the Safety and Reliability of the device will be evaluated in terms of the number of adverse events and malfunctions occurring during the study session.

For Aim 2, the efficacy of robot-assisted mobilization modes will be assessed by means of the longitudinal analysis of pre- and post-treatment measurements of MCP range of motion and pain intensity level, the flexion peak torque evaluation and the final administration of an ad-hoc satisfaction questionnaire.

For aim 3, the performance of WRL HX MCP will be studied by comparing the robotic MCP angle estimation with the measurements from a motion capture system.

Eligibility Criteria:
Inclusion Criteria:

* history of traumatic hand injury or post-traumatic hand surgery
* hand size allowing to achieve proper exoskeleton fit
* NRS pain score in the 1-5 range

Exclusion Criteria:

* cognitive or linguistic ability insufficient to understand instructions
* cardiac implanted electronic devices
* open skin at the level of the patient-device interface
* absence of contraindications for finger joints mobilisation
* current or prior history of malignancy
* pregnancy or breast feeding
Long COVID-19 Intervention Using Digital Health & Technology

The current study seeks to pilot test the iENDURE (Enhancing Distress tolerance to Uplift motivation in Recovery) intervention among 10 participants with Long COVID (Coronavirus Disease) symptoms. Following informed consent procedures, participants will complete a brief baseline assessment of self-report measures. Participants will then engage in the iENDURE intervention (described below) for 4 weeks. At the end of the intervention period, participants will complete another brief assessment of self-report measures and a qualitative interview about their experience with the program. Participants will be compensated for completing the baseline and post-intervention assessments


Eligibility Criteria:
Inclusion Criteria:

* Must be over 18 years of age
* Must speak English proficiently
* Must own a text-enabled device
* Diagnosis (self-reported) of COVID-19
* Diagnosis (self-reported) of Long-COVID symptom(s)
* Must be able to provide written, informed consent

Exclusion Criteria:

* Not fluent in English
* Limited mental capacity or inability to provide informed written consent