cyrilzakka/clinical-trials huggingface dataset:
Breast Milk Content Expressed Manually Compared to Electric Pump

Breast milk is a unique and unmatched nutritional and non-nutritive source of bioactive factors for the health and development of infants.Colostrum, which is produced in low quantities for the first 3 to 4 days after birth, is rich in immunologic components and developmental factors.

Breastfeeding difficulties during the first days of life of an infant are common. Moreover, not all infants can be directly fed at the breast.

Therefore, breast milk feeding at this early stage is initiated and promoted by the expression of breast milk either manually or by use of a pump. Whether the method of milk expression at this stage has a qualitative impact on colostrum is currently unknown.

The purpose of this randomized controlled study is to compare the effect of manual expression with electric pump expression upon the macronutrient composition of breast milk.


Eligibility Criteria:
Inclusion Criteria:

* Healthy lactating mothers of term infants

Exclusion Criteria:

* HIV infected mothers
Social Incentives To Encourage Physical Activity and Understand Predictors

This study tests the effectiveness of three social incentive-based gamification interventions to increase physical activity using a 24-week intervention period with a 12-week follow-up.

This is a four-arm randomized, controlled trial with a 24-week intervention period and 12-week follow-up period. Participants are considered ready to be randomized once they have completed all surveys, established a baseline step count, and selected a step goal increase.Participants in the control arm will receive no other interventions during the 24-week intervention period or the 12-week follow-up period. Participants randomized to the one of the three intervention arms will have a 4-week ramp up towards their step goal. The participant will then be asked to maintain their goal during the 20-week "maintenance period" and the 12-week "follow-up period." Participants in arms 2-4 will be entered into an intervention approach that has points and levels designed to incorporate insights from behavioral economics. Participants in the supportive social incentive arm will be asked to identify a family member or friend to be their support sponsor. This sponsor will be encouraged to support the participant in their progress during the study. Participants in the competitive social incentive arm will be in a group of three total participants.At the end of each week the participants will receive notification that ranks them on their cumulative points in the study thus far and also displays their level.This feedback may help to induce participants to compete for the top spot among the group. Participants in the collaborative social incentive arm will be in a group of three total participants as a team. Each day one of the members of the group will be randomly selected to represent their team for that day. In this design, each person is accountable to the others on the team and this may induce a collaborative effort to meet their daily goals.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older;
2. ability to read and provide informed consent to participate in the study;
3. Self-reported body mass index (BMI) of 25 or greater.
4. Smartphone or tablet compatible with application for the wearable activity tracking device.

Exclusion Criteria:

1. Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English;
2. conditions that would make participation unsafe such as pregnancy or being told by a physician not to exercise;
3. already enrolled in another study targeting physical activity;
4. any other medical conditions or reasons he or she is unable to participate in a physical activity study for 36 weeks.
This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors

This is the first study using PF-03758309, an oral compound, in patients with advanced solid tumors. In this study different doses of PF-03758309 will be administered to different groups of patients. The study will assess the compound's safety, the blood levels of PF-03758309 during the treatment and the effect of the compound on the tumor cells.

The study was prematurely terminated on 26Jul2011 due to the undesirable PK characteristics of PF-03758309 and the lack of an observed dose-response relationship. There were no safety concerns that contributed to the study termination.

Eligibility Criteria:
Inclusion Criteria:

* Advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available.
* ECOG (Eastern Cooperative Oncology Group) Performance Status (PS) must be 0 or 1.
* Adequate bone marrow, liver and kidney function.

Exclusion Criteria:

* Patients with known brain metastases.
* Previous high dose chemotherapy requiring stem cell rescue.
* Prior irradiation to \>25% of the bone marrow.
* Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV).
* Current active treatment in another clinical study.
* Pregnancy or breast feeding.
* Active inflammatory gastrointestinal disease, chronic diarrhea (unless related to underlying malignancy or prior related treatment) or history of abdominal fistula, gastrointestinal perforation, peptic ulcer disease, or intra-abdominal abscess within 6 months prior to study enrollment.
Aromatic Amino Acid Metabolism in the Pathogenesis of Kwashiorkor

This research may explain whether a shortage of three special compounds called aromatic amino acids is responsible for the severe illness and high death rate of children with the kwashiorkor type of malnutrition and whether supplying adequate amounts of these compounds in the treatment diet will speed up recovery from this condition. We propose that decreased availability of the aromatic amino acids may be the reason why children with kwashiorkor are sicker and more difficult to treat.


Eligibility Criteria:
Inclusion Criteria:

* Malnourished children between 6 to 18 months of age.
* To standardize for degree of malnutrition, only patients whose weight is \< 80 % of that expected for age will be enrolled. By the Wellcome Classification (22), enrolled patients will have marasmus (\< 60 % weight/age and no edema), marasmic-kwashiorkor (\< 60 % weight/age plus edema) or kwashiorkor (\< 80 % weight/age plus edema).
* Presence of infection at admission. Infection will be defined by the presence of two or more of the following: Leukocyte count \>11,000 cells/dl, temperature at admission \> 99 oF, positive blood or urine cultures.

Exclusion Criteria:

* Criteria for exclusion will include presence of cardiovascular, hepatic, renal, gastrointestinal, metabolic disease or HIV/AIDS.
Trial Comparing Loop Ileostomy Versus Loop Transverse Colostomy

The purpose of this study is to determine which stoma creation technique is preferable after low anterior resection of the rectum.

The investigators enroll patients with a histologically confirmed diagnosis of primary rectal cancer with or without prior chemoradiotherapy who were hospitalized at the Ufa Republican Clinical Oncology Center from February 2023 to February 2024.

All patients undergo planned laparoscopic or open low-anterior resection of the rectum with total mesorectal excision. Patients are randomized into 2 groups in a 1:1 ratio. In the first group, a loop transverse colostomy is created, and in the second group, a loop ileostomy is created. The stoma exit sites are marked in advance the day before the surgery. The bowels are prepared by mechanical means (a polyethylene glycol-based laxative with a cleansing enema) according to a standard procedure before the surgery. Standardized stoma creation techniques are used. The resected parts are collected through a separate access. Patients are followed up for 60 days after surgery.

The sample size should be 124 patients to reach statistical significance (α = 0.05, study power 80%, confidence interval (CI) = 95%.). Considering possible losses during the study, the number of patients was increased to 130.

The investigators hypothesis is that the loop ileostomy group has a 20% higher incidence of stoma dysfunction but a 20% lower incidence of SSI (stoma site infections) compared to the loop colostomy group.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the rectum (stages 1-3 according to MRI)
* ECOG status 0-2,
* ASA≤3.
* At least 18 years of age
* Written informed consent

Exclusion Criteria:

* Emergency surgery;
* Previously formed stoma;
* Stage 4 disease;
* Obstructive resection of the rectum;
* Patients older than 79 years
CLAD: Finding Biomarkers to Predict Rejection and/ or Outcome After Lung Transplantation

Lung transplantation is the ultimate treatment for end stage lung diseases. Survival after lung transplantation is limited mainly due to the development of chronic allograft dysfunction (CLAD). Both acute cellular rejection and primary grade dysfunction (PGD) have been associated with the development of CLAD. In this study we will investigate multiple prognostic factors that influence long term survival after lung transplantation with a specific interest in PGD, acute rejection and the development of CLAD.

At specific time points (according to protocol) exhaled breath, blood specimens, bronchoalveolar lavage and biopsies will be collected. These will be analyzed in an attempt to identify possible biomarkers that will predict the development of PGD and/or CLAD.

Eligibility Criteria:
Inclusion Criteria:

* all lung transplant recipients \> 18 years signed ICF (informed consent form)

Exclusion Criteria:

* none
Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men

The purpose of this study is to assess the tolerability, safety, and efficacy of bupropion hydrochloride sustained-release in the treatment of sexual dysfunction in men on methadone maintenance therapy.

This is a single-center (University Malaya Medical Centre), randomized, double-Blind, placebo-controlled versus bupropion hydrochloride sustained-releases study trial on 70 men who have methadone emergent sexual dysfunction. Bupropion hydrochloride sustained-release (Wellbutrin SR) 150mg once a day for 7 days then 150mg twice a day for 42 days. Taken orally by the subjects.The total duration of the study is expected to be 24 months. 20months for subject recruitment and 4 months for final subject follow-up.

The primary endpoint is Mean improvement in scores on the Clinical Global Impression Scale adapted for sexual Function (CGI-SF). Secondary endpoints are Change from baseline International Index of Erectile Function (IIEF-15) score. Mean improvement in scores on the sexual desire inventory 2 (SDI2). Other evaluation included: Montgomery-Åsberg Depression Rating Scale (MADRS- Malay version ), Mini International Neuropsychiatric Interview (M.I.N.I), Opiate Treatment Index (OTI), World health organization Quality of Life-Brief Scale (WHOQoL-Brief, Malay version), Malay Version of the Golombok-Rust Inventory of Marital State (Mal-GRIMS) and Rapid urine drug test. Safety evaluation included: Incidence of adverse events. Data will be analyzed using linear mixed-effects model.

Eligibility Criteria:
Inclusion Criteria:

* Had a diagnosis of opioid dependence base on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria
* While taking a stable dose of methadone In UMMC (University Malaya Medica Centre) and University Malaya centre of Addiction Science (UMCAS) outpatient clinic for ≥ 6 months
* Were experiencing constant sexual dysfunction for ≥ 4 weeks
* Were in a stable sexual relationship with a female partner for ≥ 6 months

Exclusion Criteria:

* Severe behavior disturbances or psychotic symptoms
* Obvious organic illnesses caused the sexual dysfunction (such as diabetics or patients with heart and vascular disease)
* Those with history of sexual dysfunction before methadone therapy
* Receiving antiviral treatment for viral hepatitis or HIV, or androgen replacement treatment.
* History of an eating disorder (eg, anorexia, bulimia) or seizures (eg, epilepsy)
* Using other psychotropic medications other than methadone
* Clinical significant abnormal laboratory values.
* Clinically significant abnormal ECG. Documented history of other psychiatric diagnosis (schizophrenia, bipolar disorder, major depressive disorder, organic brain disorder, dementia etc.)
* Refused to give participate.
Study of PTK787 in the Treatment of Patients With Non-Metastatic Androgen Independent Prostate Cancer

The purpose of this study is to evaluate PTK787/ZK 222584, a drug that blocks new blood vessel growth, in the treatment of patients with non-metastatic androgen independent prostate cancer. This study will assess the safety and tolerability of PTK787/ZK 222584, and evaluate serum vascular endothelial growth factor (VEGF) levels.

This is an open-label, phase II trial of PTK787/ZK 222584. Patients will receive 750 mg daily for one week, 1000 mg daily for the second week, and then 1250 mg per day thereafter.

Response Assessment: In the absence of toxicity or clinical progression, patients will remain in the study until their PSA (Prostate-specific Antigen) has doubled from pretreatment baseline.

Eligibility Criteria:
Inclusion Criteria:

* Histologic or cytologic diagnosis of prostate cancer
* No evidence of metastatic disease
* PSA-only progression despite androgen depravation therapy and antiandrogen withdrawal
* Patients must maintain castrate levels of testosterone (\<50ng/mL) or continue on LHRH ( Luteinizing Hormone-releasing Hormone) analog therapy.
* ECOG (Eastern Cooperative Oncology Group) performance status of 0-2 (A measure of quality of life where 0 represents asymptomatic and 5 represents death)
* No prior anti-VEGF therapy is allowed
* No investigational or commercial agents or therapies other than LHRH agonists/antagonists may be administered concurrently with intent to treat the patient's malignancy
* Age greater than or equal to 18 years
* Life expectancy greater than 6 months
* Normal organ and marrow function obtained within 14 days prior to registration
* Must use adequate contraception prior to study entry and for the duration of study participation.

Exclusion Criteria:

* Patients may continue on a daily multivitamin, but all other herbal or alternative food supplements must be discontinued before registration.
* Patients must be on stable doses of bisphosphonates which have been started no less than 6 weeks prior to protocol therapy.
* Uncontrolled incurrent illness
* Patients with a "currently active" second malignancy are not eligible.
* Major surgery less than or equal to 4 weeks prior to randomization
* Prior chemotherapy less than or equal to 3 weeks prior to registration
* Prior biologic or immunotherapy less than or equal to 2 weeks prior to registration
* Prior investigational drugs of any kind less than or equal to 4 weeks prior to registration
* Patients who have had full field radiotherapy less than or equal to 4 weeks or limited field radiotherapy equal or less than 2 weeks prior to registration.
* Patients must not be on nonsteroidal antiandrogen blockade.
* Patients must have no evidence of disease on bone scan or computed tomography (CT) scan of the abdomen/pelvis.
Efficacy of Aspirin in Preventing Venous Thromboembolism

Efficacy of aspirin and enoxaparin in preventing venous tromboembolism was compared after total knee or hip arthroplasty.

Background: Venous thromboembolism (VTE) remains a significant risk following joint replacements, despite advancements in prevention strategies. Aspirin-based therapies have gained popularity due to their perceived safety, ease of administration, and supportive evidence.This study aimed to compare the efficacy of aspirin and enoxaparin in preventing VTE after total knee or hip arthroplasty.

Methods: Sixty patients undergoing primary total knee or hip arthroplasty were randomized to receive either aspirin or enoxaparin. The primary outcome was symptomatic VTE within 90 days. Patients were followed up for Doppler ultrasound evaluations.

Eligibility Criteria:
Inclusion Criteria:

* All patients provided written informed consent.
* All patients who underwent primary total hip or total knee arthroplasty for osteoarthritis

Exclusion Criteria:

* preoperative anticoagulation (direct oral anticoagulant, warfarin, IMPROVE Bleeding Score more or equal to 7, dual antiplatelet therapy)
* medical contraindications (allergy, cancer, cardiac disease, kidney disease, or bleeding disorder precluding anticoagulation).
Multicenter Retrospective Registry of Anterior Communicating Artery Aneurysms With Endovascular Therapy

Based on the anatomical features of the anterior Communicating artery complex, the investigators will analyze the outcome of the ACoA aneurysms treated by endovascular therapy.

The most common site of intracranial aneurysms is the anterior communicating artery (AcomA). AcomA aneurysms account for approximately one-fourth of all intracranial aneurysms.

Recent publications have addressed specifically the endovascular treatment of AcoA aneurysms. Furthermore, detailed anatomic characteristics and the effects of the multiple variations of the anterior communicating artery complex have scarcely been reported.

The hemodynamic factors play a fundamental role in the adequate treatment of aneurismal coiling.

The objective of our registry is to analyze the impact of morphological configuration of the anterior communicating artery complex and the results of coil embolization in AcoA aneurysms


Eligibility Criteria:
Inclusion Criteria:

* Patient with Anterior Communicating Artery Aneurysm treated with endovascular coiling.

Exclusion Criteria:

* Patients without imaging follow up of at least 12 months after endovascular treatment.
The SaeboGlove Evaluation Trial

This study evaluates the safety, feasibility and usability of a SaeboGlove rehabilitation device in the treatment of patients who have reduced ability to open their hand due to weakness after an acute stroke.

The SaeboGlove is a new rehabilitation aid that can be used in people with hand weakness after a neurological injury. It assists the hand to open, which is crucial for people to grasp, and release everyday objects. It may improve function by doing this but may also help people with severe weakness take part more fully in therapy sessions. This glove is already marketed and is being used in some NHS sites. This trial will assess how it could be used in NHS practice in acute stroke patients and will develop a plan to implement this.

Eligibility Criteria:
Inclusion Criteria:

1. Able to consent
2. Aged ≥18 years
3. Diagnosis of stroke occurring ≤30 days ago
4. Reduced active range of movement wrist and / or finger extension
5. Modified ashworth score at wrist and fingers ≤ 2
6. Some initiation of gross active finger flexion
7. At least 10 degrees passive range of motion wrist extension
8. Considered able to learn to don / doff a SaeboGlove +/- help of willing carer
9. Ability to engage in some independent rehabilitation +/- help of willing carer
10. Considered able to comply with the requirements of protocol?

Exclusion Criteria:

1. Presence of \>5-10 degrees digital contractures
2. Presence of other upper limb impairment that would influence participation (e.g. fixed contracture, frozen shoulder, severe arthritis or upper limb pain)
3. Presence of other conditions likely to influence participation (e.g. medically unstable, registered blind, terminal cancer, severe mood, cognitive or language issues)
4. Participating in another stroke rehabilitation trial
Study of the Acceptability and Psychosocial Impact of Using a Telepresence Robot in the Living Space of Inpatients

This study focuses on the mobile robot assist device for tele-interaction: the "COVEALINK 2" robot. This telepresence robot is designed for remote use inside the home. It works with an Internet connection (Wifi or 4G). It consists of a control interface (an application installed on the smartphone or tablet of the hospitalized patient) and a mobile robot placed in the home of the hospitalized patient (composed of a mobile platform, a visualization screen whose tilt is adjustable remotely for better adaptation to the interlocutors and an audio communication system). From the app installed on his smartphone or tablet, the patient hospitalized in the center for a long time (2 months minimum) will be able to start remotely (from the center where he is hospitalized) the robot and have it move within his home to communicate with the people present at the time of use (family, friends, neighbors etc.).


Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 18 years old
* Affiliation to a social security scheme or beneficiary of such a scheme
* Having signed a free informed consent in writing
* Hospitalized in PRM for a foreseeable period of at least 60 days
* Living space compatible with the movement of the robot (verified by a home visit by the center's occupational therapist) and equipped with wifi
* Cognitive and motor functions compatible with the use of the tablet or phone independently, with learning capabilities to use the robot and the completion of questionnaires and interviews remotely
* Medically stable

Exclusion Criteria:

* Subject being in a period of exclusion from another protocol
* Mood and behavior disorders not stabilized
* Insufficient command of the French language
* Protected adults (guardianship / curatorship)
* Pregnant or breastfeeding women
* Persons deprived of their liberty
* Being unable to issue their consent
* Person who has already presented a form of addiction to technologies and / or video games
A Controlled Trial to Investigate the Efficacy and Safety of Frovatriptan to Prevent Menstrual Migraine

Although the predictability of an MRM headache attack lends itself to preventative treatment, there are currently no drugs specifically indicated for the prevention of MM. Such preventative therapies might be administered either short term (during the time around the period otherwise known as the peri-menstrual period or PMP) or continuously throughout the menstrual cycle.

Frovatriptan has been developed for the management of migraine and is already licensed for use as an acute treatment for this condition. Previous well controlled clinical trials have highlighted the potential of frovatriptan as a short-term preventative medication for MM. This clinical trial was meant to further explore this indication for frovatriptan in an expanded population.

See above

Eligibility Criteria:
Inclusion Criteria:

* Pre-menopausal females diagnosed as suffering from MRM aged 15 years and over, that fit the criteria for 'difficult to treat'
Phase 3, Febuxostat, Allopurinol and Placebo-Controlled Study in Gout Subjects.

The purpose of this study is to compare febuxostat, allopurinol and placebo, once daily (QD), in subjects with gout.

A Phase 3 Study comparing 80 mg, 120 mg or 240 mg of febuxostat, allopurinol (300 mg for those with normal renal function and 100 mg for those with impaired renal function) and placebo administered once daily in subjects with gout.

Subjects will receive treatment for 28 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Hyperuricemia (serum urate ≥8.0 mg/dL and gout by American Rheumatism Association Criteria
* Renal function defined as a serum creatinine level of \< 2.0 mg/dL and creatinine clearance of \> 20 milliliters per minute (mL/min) by Cockroft and Gault formula.

Exclusion Criteria:

* History of xanthinuria
* Intolerance to allopurinol
* Presence of renal calculi,
* Alcohol intake of ≥ 14 drinks/week
* Clinically significant medical condition