cyrilzakka/clinical-trials huggingface dataset:
A Cross Over Pilot Study of Abobotulinum Toxin A (Dysport) as a Treatment for Task-dependent Upper Limb Tremor

Task-dependent upper limb tremor is a disorder that frequently impairs patients' function and quality of life. Few studies exist that quantify the improvements in motor performance and disability with botulinum toxin (injections). The study team aims to perform an exploratory pilot trial using toxin Type A (Dysport) in 25 patients with task-dependent upper limb tremor, to refine quantitative measures of performance using blinded video analysis, demonstrate efficacy and tolerability of injections, and provide power calculations for a potential future multi-centered double blinded clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with task-dependent essential tremor in upper limb. Tremor is present during at least one of the study functional tasks i. pointing task (touch between nose and a pen held 2 ft. in front. ii. pouring task (cup: pouring water out/in). iii. feeding task (weighted fork from plate on table to mouth). iv. string instrument bowing or holding instrument in static position. v. computer mouse (simple vertical or horizontal movements).
* Patients must be capable of performing informed consent.
* Patients on stable medications for treatment of task-dependent essential tremor for 1 month prior to study entry and maintain them throughout the study.
* Patients previously treated with BoNT of any type must have occurred no sooner than 12 weeks prior to study entry.

Exclusion Criteria:

* Patients with no presence of tremor during study functional tasks.
* Presence of tremor during the functional task is below minimum amplitude required to be considered for injection based upon investigator's clinical judgment.
* Patients with unstable medical conditions or psychiatric conditions.
* Patients with a medical condition that precludes them from receiving BoNT injections.
* Pregnant women, or premenopausal women not willing to use contraceptive measures throughout the duration of the study.
* Lithium, Valproic acid, Amiodarone, typical and atypical neuroleptics. Exposure to other than the listed tremorogenic or potentially tremorogenic drugs is allowed only if, in the opinion of the investigator, this will not interfere with the study drug evaluations.
Evolution of Plasma Lipid Profile in Patients With HIV1 Who Change Atripla to Eviplera Compared to Continue With Atripla

To compare the lipidomic profile in patients with HIV-1 with viral suppression changing efavirenz + emtricitabine + tenofovir (Atripla) to rilpivirine + emtricitabine + tenofovir (Eviplera®) versus a group of patients that continue with Atripla®.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or above
* Patients infected with HIV-1
* Patients treated with Atripla at least the last 6 months.
* Patients with virologic suppression (HIV RNA \<50 copies / ml) for at least the last 6 months.
* Women of childbearing potential must use contraception double barrier.
* Voluntary signature of informed consent

Exclusion Criteria:

* Any acute or chronic (besides chronic HIV-1) disease that could interfere with the analysis of lipidomic
* Women pregnant or lactating
* Abuse of alcohol or other drugs
* Body Mass Index (BMI)\> 25
* Use of drugs that may affect lipid metabolism (lipid-lowering drugs, steroids ...)
* Patients unable to understand the study protocol or any other condition that in the investigator's opinion could jeopardize compliance with the protocol
* History or presence of allergy to any of the study drugs or their components
Efficacy and Safety of JMT101 in Patients With Advanced Solid Tumor

This study is a Phase I, open label, multi-center study of to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.

The objective of the trial is to evaluate the safety and efficacy of JMT101 in patients with advanced solid tumor.

This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.

Eligibility Criteria:
Inclusion Criteria:

* Monotherapy: Pathologically or cytologically confirmed, advanced solid tumor, harboring RAS wild type; Combined with chemotherapy: Pathologically or cytologically confirmed, locally advanced /metastatic colorectal cancer, harboring RAS and BRAF V600E wild type.
* At least 1 measurable lesion according to RECIST 1.1;
* ECOG score 0 or 1;
* Stable for more than 14 days of brain metastasis or spinal cord compression.

Exclusion Criteria:

* Receipt of any EGFR inhibitors within 5 months prior to the first dose of study treatment.
* The second primary malignant tumor was diagnosed within 5 years prior to the first dose of study treatment.
* Known hypersensitivity to any ingredient of JMT101 or their excipients;
* Major surgery within prior 4 weeks of first treatment.
* Receiving an investigational product in another clinical study within 4 weeks;
* History of serious systemic diseases;
* Pregnancy or lactating wo
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks

Noninvasive ventilation (NIV) is an established therapy that delivers positive pressure to the upper airways to provide respiratory support. Two types of NIV can be delivered; continuous positive airway pressure (CPAP) at one continuous pressure and bilevel NIV at two pressures for inhalation and exhalation.

This investigation is designed to physiologically evaluate the performance of a NIV mask, Mask A, compared to a standard NIV mask, Mask B on CPAP therapy.

People with sleep disordered breathing who have chronic hypercapnia, and are already receiving nocturnal CPAP will be recruited. They will receive one night's CPAP therapy on Mask A and 1 night on Mask B in random order. Physiological parameters will be recorded.

Parameters will be recorded during three baselines at the beginning of each evening and throughout the night when participants are asleep. The three baselines are:

1. participant awake with normal breathing (not on CPAP),
2. participant awake and on CPAP, and
3. participant asleep on CPAP in REM-sleep (rapid eye movement sleep).


Eligibility Criteria:
Inclusion Criteria:

* Already using overnight CPAP and tolerating the therapy well (over 4 hours use/night)
* Hypercapnia: venous bicarbonate of 30 milliequivalents of solute per liter (Eq/L) or more, OR transcutaneous carbon dioxide (TcCO2) of 50 millimeters of mercury (mmHg) of more.
* Provide written informed consent
* Already use a full (oronasal) face mask for CPAP
* Willing to have a venous blood sample taken during the pre-screening visit.

Exclusion Criteria:

* Presence of sleep apnea on CPAP:

  * Subjects excluded if they have an apnea-hypopnea index (AHI) of more than 20, or
  * If the AHI has not already decreased by 50 percent or more from pre-CPAP to with CPAP.
* Forced expiratory volume in 1 second (FEV1) of less than 40 percent of predicted.
* Forced expiratory volume in 1 second divided by forced vital capacity (FEV1/FVC) less than fifty percent of predicted, at the screening visit.

  * Have poorly controlled asthma or changing asthma symptoms.
  * Nasal obstruction
  * Do not fit Mask A or Mask B
  * Agitation or psychological illness
Trial of Oral Karenitecin in Patients With Solid Tumors and Lung Cancer

The purpose of this study is to determine the maximum safe dose of orally administered Karenitecin (BNP1350) in patients with solid tumors.

Initially, the safety, side effects and recommended phase 2 dose of oral Karenitecin in patients with advanced solid tumors will be determined.

When the recommended phase 2 dose has been determined, the specified dose will be used to determine if Karenitecin is effective in the treatment of patients with relapsed or refractory non-small cell lung cancer.

Eligibility Criteria:
Inclusion Criteria

* Patients entering the Phase 1 portion of the study must have a histologically or cytologically documented diagnosis of cancer (solid tumors) refractory to conventional therapeutic modalities or for which no conventional treatment exists.
* Patients entering the Phase 2 portion of the study must have a histologically or cytologically documented diagnosis of advanced (Stage IIIb/IV) NSCLC.
* Patients entering the Phase 1 portion of the study can have either measurable or evaluable disease.
* Patients entering the Phase 2 portion of the study must have measurable disease meeting RECIST criteria.
* Patients must have an ECOG performance status of less than or equal to 1.
* More than 2 weeks must have elapsed since previous chemotherapy and 6 weeks from previous treatment with nitrosoureas or mitomycin-C.
* Patients must have fully recovered from the toxic effects of prior therapy.
* Patients entering the Phase 1 portion of the study may have received up to two prior chemotherapy programs including adjuvant or neoadjuvant therapy.
* Patients entering the Phase 2 portion of the study may have received only one prior chemotherapy program including adjuvant or neoadjuvant therapy for NSCLC.
* More than 2 weeks must have elapsed since previous radiation therapy and prior radiation must be less than or equal to 15% of the bone marrow.
* Required Initial Laboratory Data: \*ANC ≥ 1,500/mm3, \*Platelet count ≥ 100,000/mm3, \*SGPT \< 1.5 times ULN, \*Alkaline phosphatase \< 2.0 times ULN, \*Bilirubin \< 1.5 mg/dl, \*Serum creatinine \< 1.5 times ULN

Exclusion Criteria:

* Pregnant or lactating women.
* Uncontrolled high blood pressure, uncontrolled diabetes mellitus, unstable angina, symptomatic congestive heart failure (CHF), myocardial infarction (MI) within 6 months, or uncontrolled arrhythmia.
* Phase 2 no previous or concurrent malignancy
* Central Nervous System (CNS) metastasis if neurologically unstable or requiring steroid use.
* Active infection.
* Known positive HIV status.
* Conditions requiring use of H2 blockers or other antacids.
* Inability to provide informed consent.
AI-guided TIPS Procedure

The goal of this clinical trial is to learn if transjugular intrahepatic portosystemic shunt (TIPS)-guided AI model can guide TIPS procedure in adults better than conventional TIPS procedure (artificially blinded TIPS). TIPS surgical outcomes and intraoperative and postoperative complications will also be observed. The main questions it aims to answer are:

* Does the AI model lower the number of punctures, radiation dose, and complications of participants undergo TIPS?
* Does the AI model improve the efficacy of TIPS for participants?

Participants will:

* Take the TIPS by the guidance of the AI model or conventional manually blinded penetration (placebo)
* The number of punctures, the success rate of the procedure, the radiation dose, intraoperative complications and postoperative complications within 3 months will be recorded
* Intraoperative portal pressure gradient drop values, symptoms of ascites and rebleeding within 3 months after TIPS will be reported


Eligibility Criteria:
Inclusion Criteria:

* Participants who require transjugular intrahepatic portosystemic shunt (TIPS) and meet the clinical indications for the procedure.
* Participants whose physical condition is suitable for TIPS.

Exclusion Criteria:

* Participants with a history of allergy or serious adverse reactions to iodine contrast media or other related drugs.
* Participants are pregnant or breastfeeding.
* Participants are unwilling or unable to sign informed consent.
Impact of Mobile Text Messaging on Follow Up Rates After Discharge From the Pediatric Emergency Department

To compare the effectiveness of text message versus voice call as a method of contact for providing results of diagnostic tests and assuring ongoing care from the pediatric emergency department.

The investigators plan to conduct a prospective randomized controlled trial to compare two means of contacting patients and their caregivers after discharge from the emergency department in order to provide results of tests: text messaging (intervention group) vs. telephone call (standard group).

Eligibility Criteria:
Inclusion Criteria:

* patients under the age of 18 who have had diagnostic testing without finalized results prior to discharge from the emergency department

Exclusion Criteria:

* Admitted patients
* Patients transferred to another facility
* Patients with critical values as results
* Do not have devices that can receive phone and text messages
* Cannot read English or Spanish
Physical Activity and Social Support Prompting Via Phone Messaging

The objective of this study was to investigate the feasibility, perceived usefulness, and potential effectiveness of a short text or voice message intervention to activate 1) physical activity behavior change among low-income, urban, Latino patients in diabetes management and 2) supportive behaviors by family members or close friends.

Despite the promise of phone-based interventions to effectively support diabetes self-management (DSM), little is known about their impact on the outcomes of highly vulnerable populations such as low-income, inner-city, racial/ethnic minorities. And while phone-based interventions have generally been successful at reaching and engaging adults with diabetes, they have failed to do the same with family members/friends (FF) whom are a promising source of ongoing support for DSM. The objective of this study was to investigate the feasibility, perceived usefulness, and potential effectiveness of a short text or voice message (ST/VM) intervention to activate 1) physical activity (PA) behavior change among low-income, urban, Latino patients in diabetes management and 2) supportive behaviors by FF. The investigators conducted a 12-week pilot study in which participants were randomized into one of three study arms: control, phone messaging (PM), and phone messaging plus social support from FF (PM+FF). Participants were recruited in person from a diabetes management program at a safety-net ambulatory care clinic. All participants were given a pedometer and walking log for self-monitoring. Participants in the PM and PM+FF arms received ST/VMs as reminders to review daily step goals and to self-monitor; explaining the benefits of regular PA, importance of regular PA to daily life, and ways to overcome commonly identified barriers to PA; asking participants to report on PA performance; providing feedback based on responses. Participants in the PM+FF identified a FF to receive ST/VMs with suggested behaviors that are perceived as supportive by individuals making PA behavior changes. Participants received semi-structured assessments in person at baseline, 6 weeks, and 12 weeks. Participants were asked about the extent to which the program enhanced the participant's ability to make PA behavior changes. The primary outcome measures were daily step counts and perceived FF social support.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Diagnosis of type 2 diabetes
* No medical conditions restricting patient from beginning a walking program
* Preferred language of English or Spanish, self-identifies as a Hispanic
* Ability to walk without the use of assistive devices such as canes or walkers
* Available to attend three interviews at the clinic
* Does not plan to move away from the region or be out of the country during the next three months
* Has a working phone where they can receive regular short text or voice messages for three months

Exclusion Criteria:

* Pregnant or breastfeeding women
Spanish Version of the Balance Evaluation Systems Test and Mini Balance Evaluation Systems Test

This study aim to translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity in spanish population.

To translate the BESTest and mini-BESTest to Spanish, adapt it and investigate its validity in spanish. Check its metric properties in relation to other balance tests.

Eligibility Criteria:
Inclusion Criteria: healthy subjects without diagnosed balance problems.

-

Exclusion Criteria:

* Diagnosed balance problems.
* One falling in the last three months.
Cetuxibab to Reduce Circulating Tumor Cells in Early Stage NSCLC

Cetuximab to reduce the amound of circulating tumor cells in early stage NSCLC

A multicenter single arm phase II trial. 40 patients with pathology proven stage I-IIIA NSCLC that are eligible for resection will be enrolled in this study. All patients will receive one dose of cetuximab prior to surgery. Blood will be drawn on multiple timepoints to assess te amount of circulating tumor cells

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Presence of surgically resectable NSCLC, stage I-IIIA, with curative intent surgery planned.
* ≥10 EGFR+EpCAM+ cells detected in the baseline blood sample.
* Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment. Both men and women enrolled in this trial must agree to use adequate barrier birth control measures (e.g., cervical cap, condom, and diaphragm) during the course of the trial. Oral birth control methods alone will not be considered adequate on this study, because of the potential pharmacokinetic interaction between study drug and oral contraceptives. Concomitant use of oral and barrier contraceptives is advised. Contraception is necessary for at least 6 months after receiving study drug

Exclusion Criteria:

* Chemotherapy or other anti-cancer therapy including radiotherapy during the study or within 4 weeks prior to the start of the study.
* Prior anti-EGFR mAb therapy
* Other currently active malignancy
* Immunosuppressive drugs during the study or within 4 weeks prior to the start of te study
* Expected adverse reactions/allergies or study medication
* Mental disorder/unable to give informed consent
* Pregnancy or breast-feeding patients
* Significant skin condition interfering with treatment
* Major surgery within 28 days before start of study.
* Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
* Any condition that is unstable or could jeopardize the safety of the subject and their compliance in the study.
Study of Inflammatory and Physiological Profiles of Healthy and Diseased Lung

There are over 700,000 UK hospital admissions every year with lung disease symptoms. Two of the most common lung diseases contributing to these numbers are asthma and chronic obstructive pulmonary disease (COPD). The immunopathology of these diseases is not fully understood. Matched samples from the respiratory tract and circulation will be used to identify immune patterns throughout the respiratory system to elucidate the immunopathology of airway disease.

In this observational study, we will be enrolling patients with diagnosed or suspected airways disease who are over 18 years old, as well as age matched healthy volunteers with no significant illness. Participants will be asked if they consent to enter the study, invited at clinically relevant time points (treatment change, disease exacerbation etc.) and to optional bronchoscopy visits. It is expected that participants will be seen yearly with any additional exacerbation/treatment visits also recorded. Research visits will occur at King's College London and the Guys and St Thomas' NHS Foundation Trust (GSTFT), with all bronchoscopy visits occurring within GSTFT

1. Disease specific questionnaires.
2. Lung function tests including spirometry or oscillometry (if not performed previously within 6 months)
3. Sputum collection
4. Nasal sampling including nasosorption, nasal brushing, nasal lavage, or nasopharyngeal swabs
5. Exhaled breath
6. Blood samples (\<6 tablespoons)

   Optional
7. Bronchoscopy involving a flexible fibreoptic camera passed into the lungs to collect bronchoalveolar lavage, bronchosorption, bronchial brushings and bronchial biopsies.
8. To repeat these procedures at later time - expected once per year or at times of clinically relevant changes

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Aged 18 years or above
* Patient: known or suspected airway disease
* Healthy volunteer: considered to be in good health with no significant comorbidity (immune disorder, cancer etc.)

Exclusion Criteria:

* Known or suspected current pulmonary tuberculosis, HIV (human immunodeficiency virus), Hepatitis B Virus, Hepatitis C Virus.
* Surgery within the preceding 6 weeks
* Participants who are pregnant
* History of psychiatric, medical, or surgical disorders that in the opinion of the chief investigator may interfere with sample collection, undergo a bronchoscopy, or may compromise study completion or data collection
* Alcohol or recreational drug abuse
* Diagnosis of immunodeficiency requiring treatment
* Unable to provide written informed consent
* Unable to read or write English
* Be considered, in the opinion of the investigator, to be an unsuitable candidate for the study
The Effect of Breakfast Size Prior to Morning Exercise on Cognition, Mood and Appetite in Habitually Active Women

Both regular exercise and breakfast consumption have well known health benefits. Consuming breakfast prior to morning exercise may influence appetite, mood and cognitive function later in the day. The purpose of this study is to test whether the amount of food consumed at breakfast prior to exercise influences these parameters in active women.


Eligibility Criteria:
Inclusion Criteria:

* Must be habitually active (exercising for least 30 minutes, 3 times per week for at least the previous 6 months)
* Must have a normal exercise routine includes a minimum of 1 morning exercise session (which takes place between 6am-11am) each week
* Must run on a regular basis (at least once per week) and be able to run at a moderate pace for 30 minutes non-stop on a treadmill
* Must consume breakfast on most days of the week, usually consume breakfast before undertaking a morning exercise session and be comfortable consuming a bowl of cereal 45mins before running

Exclusion Criteria:

* English not first language
* Smoking
* Previous or current eating disorders, metabolic disorders, gastric problems or any contraindications of exercise.
* Pregnancy
* The habitual use of some prescription or over the counter medications (excluding contraception) or herbal/dietary supplements (please ask the researcher)
* A history of or current learning difficulties, ADHD or dyslexia
* Daily use of an inhaler to control asthma
* Allergies or intolerances to any of the foods provided in the study (Special K cereal, semi-skimmed milk, pasta, tomato sauce, cheese, olive oil, rice, custard)