cyrilzakka/clinical-trials huggingface dataset:
Training Health Promotion Women Community Leaders

Goal of the Program:

To develop personal and group ability for participants in the DPP to plan and implement health promotion programs.

Objectives:

1. Develop skills in the planning, implementation, and assessment of community-based health promotion programs
2. Personal, group and community capacity development in health promotion

All participants were graduates of our previously implemented diabetes prevention program (DPP), in which women learned the health dangers involved in a sendentary life style, and unhealthy diet, a lack of planned physical activity, insufficient personal health management, and smoking. The importacne of adopting a healthy lifestyle, and how to achieve this goal was stressed. The 24 graduates most motivated to empower others were chosen to take part in this 12 session leadership program. In the leadership program, women were taught more about the manner in which to bring about a change in one's health by adopting a healthy lifestyle, leadership, and facilitation skills and the development, implementation, and evaluation process required to conduct a community program that will impact society as a whole. Women learned how to map needs and resources, define goals and objectives, implement and evaluate a community based program. Following frontal training, three action grousp were established. Each group was responsible for developing and implementing a program in the community. Programs based on initiatives set during the first stage of the DPP included: working in schools to promote a healthy lifestyle, community work targeting non-working/homemaker women ages 25+, enhancing physical activity in the community, and empowering teens. Together, all of these initiatives: increased awareness of fast food dangers, increased awareness to the dangers of nargillah smoking, and increased awareness as to the importance of physical activity.

Eligibility Criteria:
Inclusion Criteria:

* had to previously take part in the previously implemented diabetes prevention program (DPP)
* had to have interest and ability in developing programs

Exclusion Criteria:

-
A Phase 1 Study to Assess HM15275 in Healthy and Obese Subjects.

This Study is a Phase 1 Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15275 in Healthy and Obese Subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Female and male adults, ages ≥ 18 and ≤ 65 years.
2. Part A: Healthy subjects with body mass index (BMI) ≥ 20.0 kg/m2 and ≤ 27 kg/m2.

   Part B: Obese subjects with BMI ≥ 30.0 kg/m2 and ≤ 45.0 kg/m2 with a stable body weight for 3 months prior to screening (defined as change \< 5%).
3. HbA1c \< 6.5 % \[based on American Diabetes Association, 2023\].
4. Female subjects must be non-pregnant and non-lactating.
5. Subjects must be able to provide written informed consent and are willing to follow study procedures and commitment to the study duration.

Exclusion Criteria:

1. Subject with existence of any surgical or medical condition that, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product.
2. Active or untreated malignancy or has been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for \< 5 years.
3. Subjects with a history of any serious adverse reaction or hypersensitivity to study drug components (includes GLP-1, GIP, glucagon analogs) or have contraindicating diseases.
4. Subjects with confirmed type 1 or type 2 diabetes.
5. Subject is unwilling to avoid consumption of coffee and caffeine-containing beverages within from 24 hours before each study visit and while subjects are confined to the study center.
6. Subject is unwilling to abstain from vigorous exercise from 48 hours prior to admission until the Follow-up visit.
7. History of alcohol abuse as judged by the Investigator within approximately 1 year prior to Screening.
8. History of regular use (defined as ≥ 10 cigarettes per day) of nicotine-containing products (including but not limited to cigarettes, e-cigarettes, pipe, chewing tobacco, nicotine patch or gum) or vaping products within 6 weeks prior to check-in for the first In-house Period.
to Evaluate Efficacy and Safety of HLX10 in Combination With Chemotherapy Versus Placebo in Combination With Chemotherapy as Neoadjuvant Therapy and HLX10 Versus Placebo as Adjuvant Therapy in Patients With Triple Negative Breast Cancer (TNBC)

This study is a randomized, double-Blind,international multi-Centre, phase III clinical study to evaluate efficacy and safety of HLX10 in combination with chemotherapy versus placebo in combination with chemotherapy as neoadjuvant therapy and HLX10 versus placebo as adjuvant therapy in previously untreated and potentially resectable patients with TNBC and without distant metastasis.

Eligible subjects in this study will be randomized to Arm A or Arm B at 2:1 ratio as follows:

Arm A (HLX10 arm): HLX10 + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → HLX10 + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → HLX10 (9 cycles) Arm B (placebo arm): Placebo + chemotherapy (nab-paclitaxel carboplatin) (4 cycles) → Placebo + chemotherapy (doxorubicin or epirubicin cyclophosphamide) (4 cycles) → surgery → Placebo (9 cycles) The three stratification factors for randomization include: lymph node metastasis (yes or no), size of primary tumor lesion (T1/T2 or T3/T4), asian population (yes or no).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects histologically diagnosed with previously untreated TNBC (lack of human epidermal growth factor receptor-2 \[HER2\], estrogen receptor \[ER\], progesterone receptor expression as determined by the study site).
2. Subjects who are judged as one of the following by the American Joint Committee on Cancer (AJCC) within 4 weeks prior to randomisation:

   1. T1c, N1-N2, M0
   2. T2, N0-N2, M0
   3. T3, N0-N2, M0
   4. T4a-c, N0-N2, M0.
3. Major organs are functioning well
4. Participant must keep contraception

Exclusion Criteria:

1. Subjects with any other active malignancy within 5 years prior to signing the informed consent form or at the same time. Localised tumours that have been cured such as basal cell carcinoma, squamous-cell skin cancer, superficial bladder carcinoma, and cervical cancer in situ are acceptable.
2. Subjects who have received chemotherapy, targeted therapy, or radiotherapy within 12 months prior to the initial dose of the investigational product.
3. Subjects with a history of severe allergy to any monoclonal antibody or investigational product and its excipient.
4. Pregnant or lactating women.
5. Subjects with a known history of psychotropics abuse or drug abuse
6. Subjects presenting other factors not suitable for participation as judged by the investigator.
A Study to Evaluate the Safety and Efficacy of Clozapine in Patients With Treatment-resistant Schizophrenia

Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.

This study is not recruiting in the United States.

Clozapine is an antipsychotic. This 24-week study will evaluate the safety and efficacy of clozapine in patients with treatment-resistant schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as schizophrenia
* Not responded to at least two atypical antipshychotics launched in Japan
* Inpatient

Exclusion Criteria:

* Low white blood cell count
* Significant heart diseases
* Diabetes mellitus

Other protocol-defined exclusion criteria may apply.
Study of Autologous Fat Enhanced w/ Regenerative Cells Transplanted to Reconstruct Breast Deformities After Lumpectomy

A post-marketing study evaluating the transplantation of autologous fat augmented with Adipose Derived Regenerative Cells (ADRCs), in patients with functional and cosmetic breast deformities post segmental mastectomy or quadrantectomy (lumpectomy).


Eligibility Criteria:
Inclusion Criteria:

* Females with a history of T2N0M0 breast carcinoma (tumor ≤3 cm in largest dimension)
* Surgical or endoscopic segmental mastectomy or quadrantectomy (lumpectomy)
* Clean surgical margins
* No prosthesis in breast(s) to undergo treatment
* Ability to undergo lipoaspiration
* Last treatment for breast cancer ≥ 12 months prior to enrollment with absence of recurrence (patients on anti-estrogen adjuvant therapy are NOT excluded)
* No evidence of recurrence of cancer based on mammogram or breast exam prior to enrollment
* Objective signs of mild breast damage post Breast Conservation Therapy
* Type I Cosmetic Sequelae Classification
* A minimum of 1 cm of soft tissue (e.g. breast or fat) is available between the skin and chest wall at the recipient site
* A minimum of two-thirds of the breast is remaining post Breast Conservation Therapy
* No continuous adhesion of skin to bone \>3 cm in diameter
* The volume and shape of the defect(s) must be conducive to correction during a single treatment session (maximum defect volume ≤150 mL in breast(s) to undergo treatment)

Exclusion Criteria:

* History of autoimmune disorder (e.g., Systemic Lupus Erythematosus \[SLE\])
* History of connective, metabolic or atrophic skin disease
* History of keloid scarring
* Chronic use (\>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days prior to enrollment
* Life expectancy ≤ 2 years
* Recurrence or active malignancy requiring radiation or surgical treatment ≤12 months prior to enrollment
* Presence of any other known malignancy
* Body Mass Index (BMI) \>30
* Plan to undergo weight reduction surgery or foresee any significant weight changes during the study (defined as changes in BMI \>5 compared to baseline
* Presence of contraindications to MRI
A New Speech, Spatial, and Qualities of Hearing Scale Short-Form for Deaf Children

Deafness significantly affects several auditory tasks of everyday life in children: understanding speech in quiet and noisy environments, spatial location of sounds ...

These difficulties in locating sound sources are often ignored by parents and underestimated by children. Nowadays we there is specific tools to evaluate these problems in children. Indeed, there is a validated French questionnaire (Speech and Spatial Questionnaire SSQ) for adults that evaluates auditory abilities, including sound localization, in different tasks of daily life. Although robust, this questionnaire includes 49 questions and is too long for daily use in consultation. For this reason, Moulin et al validated in 2018 a short version of the SSQ questionnaire for adults with only 15 items.

Based on this model, the aim of this study is to develop and test a paediatric questionnaire with 12 items to assess more specifically auditory difficulties in deaf children. This questionnaire will follow the validated frame of the adult SSQ questionnaire and will consist of three subscales: speech hearing (4 items), spatial hearing (4 items), and qualities of hearing (4 items). These 3 subscales are identical to those defined in long and short form pf the adult SSQ questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 7-17 (inclusive)
* Attending medical appointment for temporary or persistent deafness
* Able to understand the experimental instructions

Exclusion Criteria:

none-
3D-HD Optic Systems Influence Surgical Performance

Randomized controlled trial in which two different laparoscopic systems: standard 2D and Olympus VISERA Elite II 3D will be compared in terms of laparoscopic skills, length of surgery, intraoperative complications and surgeon's fatigue in a group of senior surgeons and senior residents will be measured when performing laparoscopic Roux-en-Y gastric bypass.

The introduction of minimally invasive surgery has faced the surgeon with some difficulties that were not present in traditional open surgery. The foremost disadvantage of laparoscopy is the loss of depth perception in 2-dimensional (2D) vision while having to operate in a 3-dimensional (3D) space.

Minimally invasive surgery has become the standard approach for most of the abdominal surgical procedures. It is associated with less surgical trauma, faster recovery, shorter hospital stay and better cosmetic results. These advantages have led laparoscopic skills to become a basic competence for general surgery programs. Advanced laparoscopic surgery involves a long learning curve, including demanding minimally invasive skills such as intracorporeal suturing and knot tying.

Video quality is critical for an accurate training. This is especially important for advanced laparoscopic skills training, where high-definition cameras are needed. HD imaging has been shown to provide subjectively improved image for visualization and to improve surgical task performance.

Some authors have investigated the effect of laparoscopic 3-dimensional view, and have demonstrated an improvement in speed, efficiency, optics and handling as well as surgeon's subjective assessment. Moreover, 3D systems have been demonstrated to provide better optical visualization that allows simpler presentation of anatomical structures, which can decrease intraoperative errors and postoperative morbidity secondary to visual distortions and may reduce postoperative fatigue of the surgeon.

The hypothesis of the study is that the length of surgery is reduced with the use of 3D laparoscopic systems compared with 2D laparoscopic systems, the reduction on the length of surgery will be higher on the training surgeons compared with the senior surgeons, and that the use of 3D laparoscopic systems reduces the postoperative fatigue of the surgeons.

In this study a group of full-trained surgeons and of 4th and 5th year General Surgery Residents performing laparoscopic Roux-en-Y Gastric Bypass will be randomized into the use of 2D standard laparoscopic optics or 3D laparoscopic optics.

Eligibility Criteria:
Inclusion Criteria:

* Morbid obesity (BMI \> 30)
* Laparoscopic Gastric Bypass candidates

Exclusion Criteria:

* Non-obese patients.
* Candidates to other surgical procedures than laparoscopic gastric bypass
Melanoma Inhibitory Activity (MIA): A Serological Marker for Metastatic Uveal Melanoma

Uveal Melanoma is the most common primary intraocular tumor in adults. Most tumors metastasize to the liver. So far no sensitive or specific serological tumor marker is routinely used. The marker "Melanoma inhibitory activity" is a promising marker. Study hypothesis is to detect metastatic lesions in an early stage. This would increase life expectance of our patients

Serum is taken from each melanoma patient at every follow up after signed concent. With ELISA the marker MIA is evaluated. An increase of MIA serum level will lead to search for metastasis by oncologists.

Eligibility Criteria:
Inclusion Criteria:

* uveal melanoma (With/without overt metastatic disease)
A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant.
* Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
* Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography.
* At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age.

Exclusion Criteria:

* Previous treatment with brentuximab vedotin.
* Previously received an allogeneic transplant.
* Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
* History of another primary malignancy that has not been in remission for at least 3 years.
* Known cerebral/meningeal disease.
Post-operative Sore Throat and Gum Chewing

The purpose of this study is to determine if chewing gum immediately prior to transport to the operating room reduces the severity of post-operative sore throat in patients who have an LMA (laryngeal mask airway) placed for procedures with duration greater than 1 hour.

Patients will be randomized into two groups. Group 1 will receive a piece of gum immediately prior to transport to the operating room. They will be asked to chew the gum for 2 minutes and then spit the gum in the garbage. Group 2 will not receive any gum. They will be asked to swallow twice and have no other intervention.

Eligibility Criteria:
Inclusion Criteria:

* Outpatient ambulatory surgery
* General anesthesia utilizing a laryngeal mask airway
* Greater than 1 hour duration

Exclusion Criteria:

* Chronic laryngitis
* Chronic bronchitis
* Asthma
* Gastroesophageal reflux disease
* Smoking within the last week
* Non-English speaking
Simple Continuous, Subcuticular and Interrupted Skin Suturing of Episiotomy and 2nd-degree Perineal Tears

Millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing.

The skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. Today, as surgery increases in complexity, and the heightened public awareness of scar cosmesis and skin healing need to be optimized to ensure the overall success of the surgical procedure


Eligibility Criteria:
Inclusion Criteria:

* Normal vaginal delivery.
* At term (37 40 weeks ).
* Live baby.
* Vertex presentation

Exclusion Criteria:

* Third and fourth degree perineal tear.
* Instrumental vaginal delivery.
* Previous perineal surgery.
* Anaemia with hemoglobin level \< 9 g/dl.
* Diabetes mellitus.
* Coagulation abnormalities.
* Postpartum hemorrhage.
* Delivery conducted outside Woman HealthHospital.
* Breech delivery.
* Body mass index \>35 kg/m2.
* Local infectious lesions.
* Anal fissures or hemorrhoid.
Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery

Hallux surgery is known to be extremely painful. Standard pain therapy is treatment with NSAID and opioid painkillers. Patients are frequently not-satisfied with this. Some institutions use a nerve block (single shot or catheter technic) of the ischiadic nerve. But this procedure is invasive, has a potential risk of nerve lesion, and is not accepted by all surgeons. A single shot nerve block of the posterior tibial nerve is less invasive and could be superior compared to standard pain treatment. A great variability of nerve supply of the foot is well described. There are some hints that the posterior tibial nerve supplies the first metatarsal bone and the first metatarsal joint. A nerve block could reduce postoperative pain in hallux surgery. To assess the effectiveness of this investigated measure, the requested morphine dose of a PCA pump will be used to verify the effectiveness of the tibial nerve block.

The overall purpose is to evaluate the effectiveness of tibial nerve block for postoperative pain relief after hallux surgery. The primary objective is to assess the morphine requirement in the first 24 hours after surgery. Secondary objectives are maximum pain scores and sleeping quality in the postoperative period. Patient's satisfaction with the pain therapy and approximately nerve block duration will be asked in the final interview.

Primary study endpoint is a 50% reduction of morphine requirement with a 60% standard deviation within 24 hours after surgery. Power is 80%, the level of significance is set at 5% (p \< 0,05).

Secondary endpoints are sleeping quality and maximum pain scores (maximum VAS) measured by means of postoperative questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Elective Hallux valgus surgery ("Magerl" operation technique)

Exclusion Criteria:

* Patient refusal, pregnancy
* Regular medication with opioids
* Drug abuse
* Contraindication for regional anesthesia
* Known allergy against one of the study drugs
* Polyneuropathia, or any other neurodegenerative disorders
Connecting Audio and Radio Sensing Systems to Improve Care at Home

This study aims to assess the usability of the innovative Audio + Radio (AURA) system in enhancing personalized supportive care for cancer patients and caregivers during the post-ostomy care transition by collecting information on patient's daily activities and answers to survey questionnaire, and enabling access to this information through a voice assistant device.

The investigators will assign up to 30 cancer patients with newly created ostomies for cancer treatment with curative intent and their primary caregivers to the AURA or usual care groups (up to 30 patient-caregiver dyads, a total of 60 individuals). AURA is defined as a system that connects audio-based voice assistant devices with radiofrequency (RF) sensing technology to gather relevant patient information automatically, interactively, and with context-awareness and to store a patient's health records that otherwise had to be measured and entered manually into an electronic system. Additionally, the system enables user's access to this information through a voice assistant device. The users of this system will be the entire care team, consisting of the patient and their family members as well as the caregivers and healthcare providers at remote sites. If results indicate that the pilot trial is feasible, the investigators will design and conduct a definitive trial to examine the efficacy of AURA, a potentially scalable intervention that can be disseminated through oncology clinics nationwide to enhance post-treatment care for cancer patients with ostomies who transition from hospital professional care to self-management at home and their caregivers.

Eligibility Criteria:
Inclusion Criteria

Phase I: The investigators will only be recruiting patients for this phase

Patients must:

* have been surgically treated for colorectal or bladder cancer with curative intent;
* have had an ostomy with curative intent for at least 90 days;
* be able to read and speak English;
* be 18 years or older;

Phase II: The investigators will be recruiting patients and caregivers as a dyad for this phase

* Patients must:

  * have been surgically treated for colorectal or bladder cancer with curative intent;
  * be within one month of hospital discharge of a newly created ostomy with curative intent;
  * be able to read and speak English;
  * be 18 years or older;
  * have a caregiver who is willing to participate in the study;
* Caregivers must:

  * be 18 years or older;
  * be able to read and speak English;
  * be identified as the primary caregiver by the patient;
  * have not themselves been diagnosed with cancer or received cancer treatment during the study (to ensure that patients and caregivers focus their efforts on care of the patient).

Exclusion Criteria

Patients and their caregivers will be excluded if they:

* are unable to read, speak, or understand English;
* have more than one type of ostomy;
* have other cancer diagnosis (excluding non-melanomatous skin cancer); or
* have cognitive impairment (assessed by the Short Portable Mental Status Questionnaire).