cyrilzakka/clinical-trials huggingface dataset:
In Vitro Organoid Drug Sensitivity-Guided Treatment for Advanced Pancreatic Neuroendocrine Tumor

The purpose of this study is to explore whether chemotherapy and targeted-therapy regimens guided by organoid drug sensitivity test can improve the outcomes of non-resectable locally advanced and metastatic Pancreatic neuroendocrine tumors. At the same time, this study will evaluate the successful stablishment rate of organoid from biopsy tissue , and explore the concordance between drug sensitivity test results and patients' treatment response

Twenty non-resectable locally advanced and metastatic pancreatic neuroendocrine Tumor(p-NET) patients who should receive palliative treatment will be enrolled in this study. Baseline information of the enrolled patients including medical history, physical examination records and clinical examination records will be collected. Tumor material of those patients will be obtained from Pancreatic endoscopic biopsies or surgical resection. Patient-derived organoids (PDOs) will be established and cultured from p-NET tumor specimens. PDOs will then be treated with drugs of the chemotherapeutic and targeted therapeutic regimens for p-NET. Organoid size and growth will be monitored before and after the treatment, and dose-response curves will be generated. As for the assessment of clinical outcomes of patients, treatment responses will be assessed by biomedical imaging according to the Response Evaluation Criteria in Solid Tumors (RECIST1.1). Consistency between treatment responses in PDO models and clinical outcomes of patients will be assessed by correlation analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years old.
2. Histologically or cytologically confirmed locally advanced/metastatic Pancreatic Neuroendocrine Tumor
3. Surgery was considered impossible or can not receive the radical purpose.
4. Able to provide fresh tumor tissue specimens for organoid culture, including: tumor biopsy tissues, tumor surgical specimens, etcy.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
6. Expected survival time≥ six months.
7. Patient have been informed and consented, compliance and geographic proximity to ensure adequate follow-up

Exclusion Criteria:

1. Other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin.
2. History of severe cardiovascular events and myocardial Infarction within twelve months before the study.
3. Patients with psychiatric disorders or with psychotropic substance abuse and inability to abstain.
4. Pregnant or breastfeeding women.
5. According to researcher's consideration, patients with other serious systemic diseases or other conditions that are not suitable for participation.
Third Line Antiretroviral Treatment Optimization in Sub-Saharan Africa

Thilao is a multi-country, phase 2b, non-randomized study, in Burkina Faso, Cote d'Ivoire, Mali and Senegal, West Africa.

HIV-1 adults with 2nd-line ART virologic failure (plasma HIV-1 RNA \>1000 copies/ml) will be recruited and followed in two phases:

* First, a 12-week intentive adherence reinforcement phase, during which patients will continue 2nd-line ART, be seen repeatidly for counseling and educational training on adherence, and be offered the possibility of phone, SMS and home visit contacts with social workers;
* Second, a 48-week phase, during which:

  * Patients successfully resuppressed at the end of the first phase will continue 2nd-line ART and adherence reinforcement;
  * Patients with persitent virologic failure will switch to a darunavir/r + raltegravir-based 3rd-line ART.

Genotype resistance tests will be performed retrospectively on frozen samples. The main outcome will be the percentage of patients with plasma HIV-1 viral RNA \<50 copies/ml at 64 weeks.

Main objective

To estimate, in sub-Saharan African HIV-1 infected adults who failed a NNRTI-base first-line ART and then a PI-based second-line ART:

1. The efficacy (and associated factors) at 12 weeks of an intensive 3-months adherence reinfrocement phase;
2. In patients who successfully resuppress at 12 weeks: The percentage of patients still with continuing succesfull virologic supression on 2nd-line ART at 64 weeks (and factors associated to success) ;
3. In patients with persistent failure at 12 weeks : The efficacy (and associated factors) at 64 weeks of a darunavir/r + raltegravir-based 3rd-line regimen.

Number of participants : 200

Main outcome :

* At 12 weeks : Proportion of patients with a plasma HIV-1 RNA \<400 copies/ml and/or with a decrease in plasma HIV-1 RNA \>2 log10 copies/ml between inclusion and 12 weeks;
* At 64 weeks : proportion of patients with a plasma HIV-1 RNA \<50 copies/ml.

Inclusion criteria:

* Age \>18 years
* Documented HIV-1 infection.
* History of failing a NNRTI-based 1st-line ART
* Current PI-based 2nd-line ART \>6 months
* Plasma HIV-1 RNA \>1000 copies/ml
* Signed informed consent

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Documented HIV-1 infection
* History of failing a NNRTI-based 1st-line ART
* Current PI-based 2nd-line ART \>6 months
* Plasma HIV-1 RNA \>1000 copies/ml
* Signed informed consent

Exclusion Criteria:

* HIV-2 infection
* Any Severe clinical event under exploration
* History of treatment including darunavir or raltegravir.
Appetite and Related Factors in Patients With ALS

Chinese cnaq scale was used to evaluate the appetite changes of Chinese ALS patients; Objective to investigate the related factors of appetite changes in ALS patients; Objective to investigate the effect of anorexia on the progression and survival of ALS patients.

1. With the consent of the original author, the scale was translated and back translated, and the Chinese version of the scale was determined after communication and confirmation with the original author.
2. Cnaq was used to measure the appetite of the patients, and hads was used to measure the anxiety and depression of the patients;
3. Analyze the proportion of loss of appetite in ALS group, compare the differences of clinical characteristics such as ALSFRS-R score, weight, BMI value, cognitive status such as ECAs score between patients with loss of appetite and patients without loss of appetite in ALS group, and conduct correlation analysis.
4. The patients were followed up every three months until they were unable to eat or end-point events (invasive ventilator or death), and the correlation between cnaq and disease progression and survival was analyzed.

Eligibility Criteria:
Inclusion Criteria:

* ALS patients diagnosed as probable, or definite according to the revised El Escorial criteria

Exclusion Criteria:

* there are other chronic consumption diseases such as severe digestive system diseases, thyroid diseases, diabetes and so on.
Movement Disorder Quantification Algorithm Development

The purpose of this study is to collect kinematic motion data from subjects with movement disorders such as Parkinson's disease (PD) and essential tremor (ET) to develop and validate algorithms for quantifying motor symptoms such as tremor, bradykinesia (slowed movements), dyskinesias (sudden, involuntary movements), gait, and balance during standardized tasks and/or activities of daily living.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Clinical diagnosis of idiopathic Parkinson's disease or essential tremor
* Able to provide informed consent

Exclusion Criteria:

* Significant medical or psychiatric illness
* Not capable of following the required clinical instructions
* Serious medical conditions that compromise safety
Muscle Memory After Treatment With Anabolic Substance Clenbuterol and Resistance Training in Humans

The purpose of the project is investigate muscle memory and underlying mechanisms in humans following resistance training and use of the anabolic substance clenbuterol.


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women
* BMI of \<26 and normal ECG and blood pressure

Exclusion Criteria:

* Smoking
* Chronic disease,
* Use of prescription medication
* Pain due to current or previous musculoskeletal injury
* Resistance training more than once per week in the 12 months leading up to the intervention
* Current or previous use of prohibited anabolic substances
Effectiveness of Soft Tissue Mobilization

The aim of this study was to determine the effects of soft tissue mobilization and trigger point release verses stretching in tension-type headache among university students. Two randomized groups of participants with tension type headache will be treated with combination therapy of soft tissue mobilization and trigger point release therapy after the application of hot-pack in experimental group while control group received stretching of cervical muscles after hot-pack application .Both, male and female patients meeting the inclusion criteria will be included. Patients having malignancy and cervical tumor will be excluded.

It was a Randomized Control Trial Study. Study setting was Bashir Institute of Health sciences. Inclusion Criteria was Age 18 to 25 year's students, with tension type headache and trigger point in neck muscles. 30 Subjects were randomly and equally allocated to experimental group (n=15) and control group (n=15) through toss and coin method. Outcomes include cervical range of motions were measured by Goniometer and VAS for paini.e., used at baseline and at the final session for duration of 3 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-25 years.
* Both Male and Female gender
* Trigger points in neck muscles

Exclusion Criteria:

* Patients taking pharmacologicaldrugs.
* Presence of co morbidities.
* Malignancy/ Trauma in cervical region
* Skin infections or open wound in cervical region
The Development of a Virtual Reality Program to Improve Attention in Individuals With TBI

The purpose of this research is to investigate the effectiveness of a technique designed to improve divided attention and set-shifting impairments in persons with a traumatic brain injury (TBI). The study is designed to evaluate how well this technique can help people with TBI increase their attention and ability to function better in everyday life.

A pilot study will be conducted to evaluate the effectiveness of a technique designed to improve higher level attention (switching between tasks and multi-tasking) for persons with a traumatic brain injury. 32 individuals with TBI will be recruited. Baseline assessment includes neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. Participants are random assigned to either the experimental or control groups. Experimental and control treatments include two 60 minute sessions, twice per week, for 5 weeks. Follow-up assessment includes a neuropsychological evaluation using traditional measures as well as a completion of a number of questionnaires designed to measure everyday attention and everyday functioning. Protocol efficacy will be determined by improvements between baseline and follow-up on several objective and functional measures of divided attention and set-shifting.

Eligibility Criteria:
Inclusion Criteria:

* between the ages of 18-65
* diagnosis of TBI
* can read and speak English fluently

Exclusion Criteria:

* prior stroke or neurological disease other than TBI
* unstable or uncontrolled seizures
* currently taking benzodiazepines
Efficacy and Safety of Octreotide in Laparoscopic Hepatectomy Surgery: Effect on Blood Loss, Need for Vasoactive Drugs, Transfusion Requirements.

The goal of this double-blind clinical trial is to compare the efficacy of octreotide versus placebo in laparoscopic hepatectomy surgery in patients diagnosed with resectable hepatocarcinoma or liver metastases.

The main questions it aims to answer are:

* Decrease in intraoperative bleeding measured in ml of blood lost.
* Decrease in the need for blood transfusion and use of intraoperative vasoactive drugs.

Participants will receive octreotide or placebo after signing the informed consent form.

The drug will be administered during surgery, after anesthetic induction, and will be withdrawn at the end of surgery before leaving the operating room.

The patient will not receive any visit or require the performance of any other additional tests that are performed in the usual clinical practice. The monthly follow-up will coincide with the medical check-up and control analytical data will be taken. Subsequently, an attempt will be made to contact with the patient 3 months after surgery.

The duration of participation of each participant in the trial will therefore be about 3 months after surgery.

The intervention group will receive a loading dose of octreotide (100 mcgr) diluted in 100 ml of SSF to be given in half an hour and after that a continuous perfusion of 25 mcgr/h will be started until the end of the surgery.

The pharmaceutical form to be used is Sandostatin.

The control group will receive SSF as a placebo in the same sequence, first a loading dose in half an hour and then a continuous infusion of 25 mcgr/h until the end of surgery.

and then a continuous infusion until the end of the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hepatic lesions who are going to undergo hepatectomy via laparoscopy.
* The patient must be between 18 and 80 years old.
* The patient, or his/her representative, has given his/her consent to participate in the study.
* The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
* The patient must not be allergic to the drug.

Exclusion Criteria:

* History of hypersensitivity to the drug to be administered.
* Children under 18 years of age.
* Urgent intervention.
* Intervention performed in an open manner (not laparoscopic).
* Patient's refusal to participate in the study.
* Contraindication to receive octreotide.
* Women of childbearing age (those women who are in the period between menarche and menopause). Having to present a negative pregnancy test to take part in the study.
* Pregnant or lactating women, given the absence of studies of this drug in this patient profile.
New Version Pulmicort Turbuhaler USA Children

A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in children and adolescents who have asthma. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.


Eligibility Criteria:
Inclusion Criteria:

* Male or females aged 6 to 17 with a diagnosis of asthma for at least 3 months. Have used inhaled corticosteroids for no more than one month before entering the study or none at all.
* A forced expiratory volume (FEV1) in 1 second of 75% to 90% of predicted normal for those aged 6 to 11 and 60% to 90% for those aged 12 to 17 years.
* Airway reversibility of at least 12% , use of orally inhaled corticosteroids for no more than one month immediately before entering the study or none at all.

Exclusion Criteria:

* Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
* Use of steroid tablets or injections during the month prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
* Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to Visit 1. Must not smoke or have smoked.
Percutaneous Tibial Nerve Stimulation for Patients With Fecal Incontinence

Percutaneous tibial nerve stimulation is introduced as regular treatment option for fecal urge continence at the Cantonal Hospital St. Gallen. During this introduction phase efficiency und adverse events will be monitored in this observational study.

Before treatment patients will have a proctological exam, a proctoscopy, endosonography and anorectal manometry. Incontinence scores (Wexner, Vaizey, Hanley) and quality of life scores (FIQL, VAS) will be recorded.

Treatment consists of 4 phases with decreasing frequency of percutaneous tibial nerve stimulations (pTNS).

During phase 1 weekly stimulations of 30 mins are applied for 12 weeks. After 6 and 12 weeks incontinence scores are recorded. Additionally after the end of phase 1 quality of life is measured and an anorectal manometry is preformed.

Phase 2 lasts for 8 weeks, with 2-3 stimulations/month Phase 3 lasts for 8 weeks, with stimulations every 3 weeks Phase 4 consists of one stimulation in one month.

After phase 4 incontinence scores und quality of life are measured.

Eligibility Criteria:
Inclusion Criteria:

* fecal urge incontinence
* conservative treatment has been performed without success

Exclusion Criteria:

* current anticoagulation treatment
* sphincter defects larger than 120°
* pregnancy
* pace maker
* implanted defibrillators
* severe heart disease
* existing neurological damages
* disposition for strong bleeding
Validation of a Screening Tool in Geriatric Oncology

RATIONALE: A screening questionnaire may help doctors plan better treatment for older patients with cancer.

PURPOSE: This clinical trial is studying a questionnaire in screening older patients with cancer.

OBJECTIVES:

Primary

* Validate a new screening tool (G8).

Secondary

* Validate the French version of the screening tool "Vulnerable Elders Survey (VES-13)".
* Evaluate the merits of the screening tools (G8 and VES-13).
* Assess the screening tool in specific populations.
* Assess the number and type of interventions proposed after thorough geriatric assessment.
* Compare the two new tools (G8 vs VES-13).

OUTLINE: This is a multicenter study.

During the first consultation, patients have an initial clinical evaluation questionnaire comprising the G8. They also complete the self-questionnaire VES-13. Within 30 days, patients have a thorough geriatric assessment, including quality of life and physical function, by a physician without access to the G8 or VES-13 questionnaires. A blood specimen is also collected.

Information on health status and quality of life is collected from medical records or from the doctor after 1 and 5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed cancer including the following types:

  * Colon
  * Rectal
  * Lung
  * Squamous cell carcinoma of the head and neck
  * Breast
  * Prostate
  * Non-Hodgkin lymphoma
* Planning to undergo first-time treatment comprising medicine, surgery, or radiotherapy

PATIENT CHARACTERISTICS:

* No persons deprived of liberty or under guardianship
* No psychological, familial, social, or geographical reasons that would make monitoring clinically impossible

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women

Researchers are evaluating the safety of triptan treatment of migraine in individuals with elevated cardiovascular risk and in pregnant women.

Migraine is a very common condition that can be associated with significant morbidity. For the acute treatment of migraine attacks, the use of triptans, NSAIDs, acetaminophen, dihydroergotamine, calcitonin gene-related peptide antagonists, lasmiditan, and some nonpharmacologic treatments are associated with improved pain and function. The effectiveness of these therapies has been documented in various studies and summarized in systematic reviews. However, systematic reviews have demonstrated evidence gaps in two groups of patients that were excluded from treatment trials. These are patients with cardiovascular disease or at high risk of cardiovascular events, and pregnant women.

Triptans, the mainstay treatment for migraine attacks and the one supported by the highest quality evidence, are considered vasoactive and are contraindicated per formulary in individuals who have a history of myocardial infarction, stroke, or uncontrolled vascular risk factors such as hypertension. These individuals are usually excluded from randomized trials. Similarly, pregnant women have been excluded from triptans trials and the observational studies offered low certainty evidence about their safety. Yet, 44% of surveyed members of the American Headache Society reported being somewhat or very comfortable using triptans in pregnancy.

Therefore, the investigators intend to evaluate the safety of triptan treatment of migraine in individuals with cardiovascular disease or multiple cardiovascular risk factors, and in pregnant women in two target trial emulations.

Eligibility Criteria:
Treatments of Migraine With Triptans in Individuals With Elevated Cardiovascular Risk:

Inclusion:

* Aged \>=18 years
* At least 1 year history of migraine with or without aura
* Confirmed cardiovascular or cerebrovascular disease, including myocardial infarction (MI), coronary artery disease (CAD), cerebrovascular disease, stroke; or at least 2 cardiovascular risk factors, including diabetes, hyperlipidemia, hypertension, obstructive sleep apnea, peripheral vascular disease;
* At least 1 year of prior triptan treatment or no previous triptan treatment.

Exclusion:

• Prescription of ergot alkaloids or dihydroergotamine within 60 days before or after starting treatment

Treatments of Migraine With Triptans in Pregnant Women

Inclusion:

* Aged \>=18 years
* Pregnant woman
* Diagnosis of episodic or chronic migraine with or without aura before pregnancy

Exclusion:

• Prescription of ergot alkaloids or dihydroergotamine \<= 60 days before pregnancy or during pregnancy
Hyperinsulinemic Therapy in Sepsis

Insulin regulates blood sugar and acts to suppress inflammation. Hyperinsulinemic Therapy is a protocol for Insulin administration that involves the administration of a calculated higher dose of insulin into the blood stream. This therapy is called dextrose/insulin clamp. It has been shown to be safe and successful in maintaining normal glucose levels.

The objective of the study is to assess if the clamp can achieve a steady and normal blood glucose level in patients admitted to the intensive care unit with sepsis. Furthermore, if the higher insulin dose would lead to a drop in the inflammatory response seen in septic patients.


Eligibility Criteria:
Inclusion Criteria:

* Admission to the ICU with a diagnosis of Septic shock or Severe Sepsis.

Exclusion Criteria:

* Age less than 18 years old.
* Pregnancy.
* Patients who cannot provide informed consent and there is no surrogate decision maker.
* A delay of more than 24 hours between eligibility and randomization.
* Patients admitted to the intensive care unit for treatment of diabetic ketoacidosis or hyperosmolar state.
* Imminent death.
* Patients who the treating clinicians are not committed to full supportive care. This is confirmed by a documented treatment-limitation order that exceeds a "do-not-resuscitation" order.